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HSMN NewsFeed - 22 May 2026
AbbVie Announces Positive CHMP Opinion for MAVIRET(R) (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 May 2026
Partner Therapeutics Announces FDA Approval of BIZENGRI(R) (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner's National Priority Voucher
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Apr 2026
Lilly's Jaypirca (Pirtobrutinib) Significantly Extended Progression-Free Survival When Added to a Venetoclax Time-Limited Regimen in Patients with Previously Treated CLL/SLL
Biopharmaceuticals Oncology

HSMN NewsFeed - 22 Dec 2025
U.S. FDA Approves JASCAYD(R) (nerandomilast) Tablets for the Treatment of Progressive Pulmonary Fibrosis in Adults
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Dec 2025
BioMarin to Acquire Amicus Therapeutics for $4.8 Billion, Expanding Position as a Leader in Rare Diseases, Accelerating Revenue Growth and Strengthening Financial Outlook
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 8 Oct 2025
Lumen Bioscience Expands Board and Leadership Team to Advance Clinical Pipeline of Novel Oral Biologics
Biopharmaceuticals Personnel

HSMN NewsFeed - 15 Aug 2025
Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Jun 2025
Cristcot Appoints Richard Kim as Chief Commercial Officer
Biopharmaceuticals Gastroenterology Personnel

HSMN NewsFeed - 17 Jan 2025
FDA Approves LUMAKRAS(R) (Sotorasib) in Combination with Vectibix(R) (Panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Jan 2025
UCB Announces U.S. Availability of 320 mg/2 mL Single-Injection Administration Option for BIMZELX(R) (bimekizumab-bkzx)
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 30 Dec 2024
Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig(TM) with ENHANZE(R) for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo(R) (nivolumab) Indications
Biopharmaceuticals Drug Delivery Oncology FDA

HSMN NewsFeed - 23 Sep 2024
UCB Announces U.S. FDA Approvals for BIMZELX(R) (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Sep 2024
Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI(TM) (trastuzumab-strf), a biosimilar to Herceptin(R) (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 20 Aug 2024
RYBREVANT(R) (amivantamab-vmjw) Plus LAZCLUZE(TM) (lazertinib) Approved in the U.S. as a First-line Chemotherapy-free Treatment for Patients with EGFR-mutated Advanced Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Jun 2024
TALVEY(R) (talquetamab-tgvs) Demonstrates Highly Durable, Longer-Term Responses in Patients with Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Mar 2024
Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS(R)
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 11 Mar 2024
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA(R) (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Feb 2024
AbbVie Completes Acquisition of ImmunoGen
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 26 Dec 2023
Amgen Provides Regulatory Update on Status of Lumakras(R) (Sotorasib)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Oct 2023
FDA Approves Novartis Cosentyx(R) as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decade
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Aug 2023
AbbVie Announces European Commission Approval of AQUIPTA(R) (atogepant) for the Preventive Treatment of Migraine in Adults
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 20 Jul 2023
Boehringer Ingelheim Receives FDA Approval for NexGard(R) PLUS (afoxolaner, moxidectin and pyrantel chewable tablets): A Beef-Flavored Soft Chew That Protects Dogs from Internal and External Parasites
Biopharmaceuticals Veterinary FDA

HSMN NewsFeed - 9 Jun 2023
Astellas Submits New Drug Application for Zolbetuximab in Japan
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 29 Dec 2022
FDA Grants Appeal for Ardelyx's XPHOZAH(R) (tenapanor)
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 26 Sep 2022
Innocoll and DURECT Announce U.S. launch of POSIMIR(R)
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 19 Sep 2022
AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI(R)) for the Treatment of Adults with Moderate to Severe Crohn's Disease
Biopharmaceuticals Gastroenterology Regulatory

HSMN NewsFeed - 4 Aug 2022
Amgen to Acquire Chemocentryx for $4 Billion in Cash
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 21 Jul 2022
Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO(R) (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 7 Jul 2022
Renovia receives FDA clearance for leva(R) Pelvic Health System as first-line treatment for chronic fecal incontinence
Devices FDA

HSMN NewsFeed - 14 Apr 2022
NCCN Guidelines(R) Recommend VONJO(TM) (pacritinib) for the Treatment of Myeloproliferative Neoplasms
Biopharmaceuticals Oncology

HSMN NewsFeed - 6 Apr 2022
FDA approves Novartis Vijoice(R) (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Apr 2022
Ardelyx Announces US Launch of IBSRELA(R), a New First-in-Class Treatment for IBS-C in Adults
Biopharmaceuticals Gastroenterology Product Launch

HSMN NewsFeed - 18 Mar 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of the BRIGHT Phase III Clinical Trial Evaluating PRX-102 for the Treatment of Fabry Disease
Biopharmaceuticals

HSMN NewsFeed - 28 Jan 2022
Blueprint Medicines' AYVAKYT(R) (avapritinib) Receives Positive CHMP Opinion for the Treatment of Adults with Advanced Systemic Mastocytosis
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 5 Jan 2022
Meridian Bioscience Receives FDA Clearance for the Curian(R) Campy Assay
Diagnostics FDA

HSMN NewsFeed - 19 Nov 2021
BioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Oct 2021
FDA Approves Verzenio(R) (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Sep 2021
OLUMIANT(R) Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata
Biopharmaceuticals

HSMN NewsFeed - 27 Sep 2021
Japan's MHLW Approves PADCEV(R) (enfortumab vedotin) for Advanced Urothelial Cancer
Biopharmaceuticals Urology Oncology Regulatory

HSMN NewsFeed - 16 Sep 2021
LUMAKRAS(TM) (Sotorasib) Combined With Vectibix(R) (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 9 Aug 2021
SKYRIZI(R) (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology Product Launch

HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Jul 2021
Sandoz launches first generic high dose intravenous iron, Ferumoxytol Injection, to treat US patients with iron deficiency anemia
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 12 Jul 2021
Janssen Announces U.S. FDA Approval of DARZALEX FASPRO(R) (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jun 2021
Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jun 2021
Evrysdi(TM) Approved in Japan for the Treatment of Spinal Muscular Atrophy
Biopharmaceuticals Regulatory

HSMN NewsFeed - 1 Apr 2021
United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 30 Mar 2021
PTC Therapeutics Announces the European Approval of Evrysdi(TM) for the Treatment of Spinal Muscular Atrophy
Biopharmaceuticals Regulatory

HSMN NewsFeed - 26 Mar 2021
Constipation treatment Vibrant raises $7.5 million led by Unorthodox Ventures
Devices Gastroenterology Venture Capital

HSMN NewsFeed - 26 Mar 2021
European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 26 Feb 2021
Lilly announces additional doses of neutralizing antibody therapy purchased by U.S. government to treat COVID-19
Biopharmaceuticals

HSMN NewsFeed - 12 Feb 2021
The Lancet Publishes Libtayo(R) (cemiplimab) Data Showing Extended Overall Survival in Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Feb 2021
DURECT Corporation Announces U.S. FDA Approval of POSIMIR(R) For Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 25 Jan 2021
Eiger BioPharmaceuticals Announces U.S. Commercial Availability of Zokinvy(TM) (lonafarnib), the First and Only Treatment Approved for Progeria and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals Product Launch

HSMN NewsFeed - 22 Dec 2020
Soligenix Announces Topline Results from its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Dec 2020
FDA Approves GSK's BENLYSTA as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Dec 2020
BAVENCIO(R) (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 25 Nov 2020
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Oct 2020
Titan Pharmaceuticals Provides a Strategic & Corporate Update
Biopharmaceuticals Personnel

HSMN NewsFeed - 6 Oct 2020
REYVOW(R) (lasmiditan) C-V Demonstrated Superior Pain Freedom At 2 Hours in At Least 2 of 3 Migraine Attacks in New Phase 3 Consistency of Effect Study
Biopharmaceuticals Neurology

HSMN NewsFeed - 25 Sep 2020
Blueprint Medicines Announces European Commission Approval of AYVAKYT(R) (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Sep 2020
REYVOW(TM) (lasmiditan) C-V Demonstrated Pain Freedom from Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 Study
Biopharmaceuticals Neurology

HSMN NewsFeed - 14 Aug 2020
Lupin Presents Phase 3 Data for Solosec(R) (secnidazole) Demonstrating Significant Response Rate in Female Patients with Trichomoniasis
Biopharmaceuticals

HSMN NewsFeed - 30 Jul 2020
Jardiance(R) meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 24 Jul 2020
Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 22 Jul 2020
Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 20 Jul 2020
FDA Clears Abivertinib for Phase 2 Safety and Efficacy Study in Hospitalized Patients with Moderate To Severe Covid-19
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Jul 2020
TREMFYA(R) (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Jun 2020
Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
Biopharmaceuticals

HSMN NewsFeed - 18 Jun 2020
Almirall Announces FDA Approval Of Updated Label For Seysara(R) (Sarecycline) Tablets
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 5 May 2020
Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis
Biopharmaceuticals

HSMN NewsFeed - 22 Apr 2020
Novartis Kymriah(R) receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
Biopharmaceuticals Regenerative Medicine Oncology FDA

HSMN NewsFeed - 9 Apr 2020
EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO(R) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Mar 2020
EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Feb 2020
Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV(TM) (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Dec 2019
HIZENTRA(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) Receives Orphan-Drug Exclusivity for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 8 Nov 2019
Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA(R) (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Nov 2019
EIP Pharma Announces Clinical Trial Results of REVERSE-SD, a Phase 2b Study of Neflamapimod in Early-stage Alzheimer's Disease
Biopharmaceuticals Neurology

HSMN NewsFeed - 5 Nov 2019
Regeneron Provides Updates on Phase 3 Libtayo(R) (cemiplimab) Development Program in Advanced Non-small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Oct 2019
Biogen and Alkermes Announce FDA Approval of VUMERITY(TM) (diroximel fumarate) for Multiple Sclerosis
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Oct 2019
Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI(R) Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Oct 2019
Nplate(R) (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Oct 2019
FDA Grants Ofev(R) Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Oct 2019
Upsher-Smith Laboratories Launches Tosymra(TM) (sumatriptan) Nasal Spray For The Acute Treatment Of Migraine In Adults
Biopharmaceuticals Neurology Drug Delivery Product Launch

HSMN NewsFeed - 20 Sep 2019
CHMP Issues Positive Opinion to Expand Trulicity(R) (dulaglutide) Label to Include Results from REWIND Cardiovascular Outcomes Trial
Biopharmaceuticals Endocrinology Cardiology Regulatory

HSMN NewsFeed - 11 Sep 2019
Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations
Biopharmaceuticals Oncology

HSMN NewsFeed - 9 Sep 2019
Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Aug 2019
Amgen To Acquire Otezla(R) For $13.4 Billion In Cash, Or Approximately $11.2 Billion Net Of Anticipated Future Cash Tax Benefits
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 14 Aug 2019
Regeneron Announces Positive Topline Results from Phase 3 Trial of Evinacumab in Patients with Severe, Inherited Form of High Cholesterol
Biopharmaceuticals Cardiology

HSMN NewsFeed - 1 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo(R) (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Jul 2019
Lilly's Verzenio(R) (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Jun 2019
U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 14 Jun 2019
Janssen reports top-line Phase 3 results for TREMFYA(R) (guselkumab) in adults with active psoriatic arthritis
Biopharmaceuticals

HSMN NewsFeed - 12 Jun 2019
CutisPharma Announces Acquisition Of Silvergate Pharmaceuticals, Name Change To Azurity Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 30 May 2019
U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA(R) (gilteritinib)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 May 2019
U.S. FDA Approves GATTEX(R) (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 8 May 2019
Daiichi Sankyo Announces [Fam-] Trastuzumab Deruxtecan Demonstrated Clinically Meaningful Response in Patients with Refractory HER2 Positive Metastatic Breast Cancer, a Population with High Unmet Need
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Apr 2019
Aratana Therapeutics to be Acquired by Elanco Animal Health
Biopharmaceuticals Veterinary Mergers & Acquisitions

HSMN NewsFeed - 18 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Biopharmaceuticals FDA Regulatory

HSMN NewsFeed - 18 Mar 2019
Allergan Announces FDA Approval of AVYCAZ(R) (ceftazidime and avibactam) for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Feb 2019
FDA Approves Taiho Oncology's LONSURF(R) (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Feb 2019
Boehringer Ingelheim and Lilly announce the CAROLINA(R) cardiovascular outcome trial of Tradjenta(R) met its primary endpoint of non-inferiority compared with glimepiride
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 12 Feb 2019
U.S. FDA Approves DARZALEX(R) (daratumumab) Split-Dosing Regimen
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Jan 2019
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Jan 2019
Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO(R)
Biopharmaceuticals Oncology

HSMN NewsFeed - 15 Jan 2019
CutisPharma Announces New Management Team Appointments
Biopharmaceuticals Personnel

HSMN NewsFeed - 2 Jan 2019
Slayback Pharma Announces FDA Approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml in a Multi-Dose Vial, the First Generic Equivalent of Makena(R) Injection 1,250 mg/ 5 ml Multi-Dose Vial
Biopharmaceuticals Generics FDA Product Launch

HSMN NewsFeed - 18 Dec 2018
Lilly Announces Publication of Analyses Showing Benefit of the Addition of Verzenio(R) (Abemaciclib) in Multiple Subgroups of Patients with Advanced Breast Cancer Identified as Having a More Concerning Prognosis
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Nov 2018
FDA Approves AEMCOLO(TM) (rifamycin), the First Antibiotic Approved for the Treatment of Travelers' Diarrhea in Over a Decade
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 19 Nov 2018
Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Avelumab in Platinum-Resistant/Refractory Ovarian Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 Nov 2018
AbbVie Receives European Commission Approval of VENCLYXTO(R) (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 30 Oct 2018
U.S. FDA Approves INVOKANA(R) (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 17 Oct 2018
AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA(R) (ibrutinib) in Combination with Obinutuzumab (GAZYVA(R)) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Oct 2018
Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic Immune Thrombocytopenia (ITP) in Adult Patients
Biopharmaceuticals Regulatory

HSMN NewsFeed - 1 Oct 2018
FDA Approves KYPROLIS(R) (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Sep 2018
Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Imodium(R) Multi-Symptom Relief
Biopharmaceuticals Generics FDA Product Launch

HSMN NewsFeed - 27 Aug 2018
AbbVie Announces IMBRUVICA(R) (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström's Macroglobulinemia, a Rare Type of Blood Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Aug 2018
Vyxeos(R) Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 17 Aug 2018
Eisai And Merck Announce FDA Approval Of LENVIMA(R) (lenvatinib) Capsules For First-Line Treatment Of Unresectable Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Aug 2018
US Food and Drug Administration Approves ARAKODA(TM) (tafenoquine) tablets for oral use; First preventative antimalarial approved in almost two decades
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Aug 2018
Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX(R) (daratumumab) Split Dosing Regimen
Biopharmaceuticals Oncology FDA Regulatory

HSMN NewsFeed - 8 Aug 2018
United Therapeutics Announces FREEDOM-EV Study Of Orenitram Meets Primary Endpoint
Biopharmaceuticals

HSMN NewsFeed - 7 Aug 2018
Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI(TM) in combination with MEKTOVI(R) and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Jul 2018
FDA Grants Approval of TIBSOVO(R), the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Jul 2018
The National Comprehensive Cancer Network (NCCN) Guidelines Recommend BRAFTOVI(TM) (encorafenib) in Combination with MEKTOVI(R) (binimetinib) as a Category 1 Treatment Option for Patients with Advanced BRAF-mutant Melanoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Jul 2018
Phase III IMpassion130 Study Showed Genentech's TECENTRIQ Plus Abraxane Significantly Reduced the Risk of Disease Worsening or Death in People With Metastatic or Locally Advanced Triple Negative Breast Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 29 Jun 2018
Ultragenyx Announces Positive CHMP Opinion for Mepsevii(TM) (vestronidase alfa) For the Treatment of Mucopolysaccharidosis VII
Biopharmaceuticals Regulatory

HSMN NewsFeed - 26 Jun 2018
Salix And US WorldMeds Enter Into Exclusive Co-Promotion Agreement For Opioid Withdrawal Treatment LUCEMYRA(TM) (lofexidine)
Biopharmaceuticals Distribution

HSMN NewsFeed - 25 Jun 2018
IMBRUVICA(R) (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Jun 2018
Mallinckrodt Reports Interim Findings Of H.P. Acthar(R) Gel (Repository Corticotropin Injection) Studies
Biopharmaceuticals

HSMN NewsFeed - 15 Jun 2018
AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab at 23rd European Hematology Association Annual Congress
Biopharmaceuticals Oncology

HSMN NewsFeed - 13 Jun 2018
Evolve BioSystems Announces $40 Million Series C Financing to Expand its Flagship Infant Probiotic Product Evivo
Biopharmaceuticals Gastroenterology Venture Capital

HSMN NewsFeed - 6 Jun 2018
Partner Therapeutics (PTx) Announces US FDA Approval of Leukine(R) (sargramostim) for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jun 2018
FDA Expands Lilly's ALIMTA(R) (pemetrexed) Label to Include Combination with KEYTRUDA(R) (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 May 2018
FDA expedites review of Novartis drug Promacta(R) for first-line severe aplastic anemia (SAA)
Biopharmaceuticals FDA

HSMN NewsFeed - 29 May 2018
ADAPT Pharma(R) Launches NARCANDirect.com
Biopharmaceuticals Product Launch

HSMN NewsFeed - 24 May 2018
IMBRUVICA(R) (ibrutinib) Plus GAZYVA(R) (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint
Biopharmaceuticals Oncology

HSMN NewsFeed - 25 Apr 2018
FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 23 Apr 2018
Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV(R) (telavancin) at 2018 ECCMID(TM) Conference
Biopharmaceuticals

HSMN NewsFeed - 20 Apr 2018
FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Apr 2018
BD Unveils Suite of Diagnostic Informatics and Automation Innovations
Diagnostics Product Launch

HSMN NewsFeed - 16 Mar 2018
FDA Approves Hizentra(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Mar 2018
CTI BioPharma Announces Publication of Pacritinib Phase 3 PERSIST-2 Clinical Trial in JAMA Oncology
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Mar 2018
U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 26 Feb 2018
New Data Show Lilly's Trulicity(R) (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 23 Feb 2018
Amgen Receives Positive Opinion Expanding Use Of XGEVA(R) (denosumab) To Cover Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma In Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 8 Feb 2018
ZYTIGA(R) (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Feb 2018
FDA Approves AVYCAZ(R) (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Feb 2018
Partner Therapeutics (PTx) Acquires Leukine(R) from Sanofi
Biopharmaceuticals Oncology Acquisitions

HSMN NewsFeed - 23 Jan 2018
TECHLAB Receives FDA 510(k) Clearance To Market CAMPYLOBACTER QUIK CHEK(TM) and CAMPYLOBACTER CHEK(TM) Tests
Diagnostics Gastroenterology Product Launch

HSMN NewsFeed - 22 Jan 2018
Elanco Animal Health Announces U.S. Food and Drug Administration (FDA) Approval of Credelio(R) (lotilaner) to Treat and Protect Against Ticks and Fleas
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jan 2018
Independent Imaging Review Confirmed Positive Data from Primary Analysis of REFLECT Trial Evaluating Lenvatinib Compared to Sorafenib in Unresectable Hepatocellular Carcinoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Jan 2018
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jan 2018
Pharming Announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Jan 2018
Novartis new data reinforces superiority of Cosentyx(R) versus Stelara(R) in achieving skin clearance for psoriasis patients
Biopharmaceuticals Dermatology

HSMN NewsFeed - 10 Jan 2018
BYDUREON(R) BCise(TM) Injectable Medicine Now Available In The US For Patients With Type-2 Diabetes
Biopharmaceuticals Endocrinology Product Launch

HSMN NewsFeed - 5 Jan 2018
FDA Approves XGEVA(R) (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Jan 2018
Novartis drug Promacta(R) receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Dec 2017
Novartis' combination therapy Tafinlar(R) + Mekinist(R) granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 12 Dec 2017
DARZALEX(R) (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Dec 2017
INVOKANA(R) (canagliflozin) Significantly Improved Renal Outcomes and Demonstrated Potential Renal Protective Effects in Patients with Type 2 Diabetes Who Have or Are at Risk for Cardiovascular Disease
Biopharmaceuticals Nephrology

HSMN NewsFeed - 1 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Nov 2017
GenePOC Launches its GenePOC(TM) CDiff Test in the United States
Diagnostics FDA Product Launch

HSMN NewsFeed - 27 Nov 2017
Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Nov 2017
Noden Pharma Announces FDA Approval of Tekturna(R) (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 15 Nov 2017
Outpost Medicine Appoints Scott Byrd as Chief Executive Officer and Raises $20 Million in Series A Financing Extension
Biopharmaceuticals Venture Capital Personnel

HSMN NewsFeed - 20 Oct 2017
Celgene Provides Update on GED-0301 (mongersen) Inflammatory Bowel Disease Program
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 12 Oct 2017
Ortho Dermatologics Announces Two-Year Findings From Pivotal Phase 3 Study Of SILIQ(TM) (brodalumab) Injection Data Demonstrating Long-Term Efficacy Profile
Biopharmaceuticals Dermatology

HSMN NewsFeed - 12 Oct 2017
FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio(TM) (abemaciclib) as Initial Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Sep 2017
European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 15 Sep 2017
Janssen Receives CHMP Positive Opinion for Guselkumab Recommending Approval for the Treatment of Moderate to Severe Plaque Psoriasis in the European Union
Biopharmaceuticals Dermatology Regulatory

HSMN NewsFeed - 14 Sep 2017
Pfizer and Astellas Announce Positive Top-Line Results from Phase 3 PROSPER Trial of XTANDI (enzalutamide) in Patients with Non-Metastatic Castration-Resistant Prostate Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 11 Sep 2017
Oncolytics Biotech(R) Announces the Presentation of REOLYSIN(R) Clinical Data at ESMO 2017 Congress
Biopharmaceuticals Oncology

HSMN NewsFeed - 7 Aug 2017
Impax Announces Settlement of Contract Litigation on Opana(R) ER (Oxymorphone Hydrochloride) CII Extended-Release Tablets
Biopharmaceuticals Litigation

HSMN NewsFeed - 27 Jul 2017
Valeant Announces U.S. Launch of SILIQ(TM) (brodalumab) Injection
Biopharmaceuticals Dermatology Product Launch

HSMN NewsFeed - 25 Jul 2017
HAEGARDA(R) (C1 Esterase Inhibitor Subcutaneous [Human]) Now Available in the United States for Patients with Hereditary Angioedema
Biopharmaceuticals Product Launch

HSMN NewsFeed - 24 Jul 2017
eFFECTOR Therapeutics Completes $38.6 Million Series C Financing
Biopharmaceuticals Oncology Venture Capital Personnel

HSMN NewsFeed - 21 Jul 2017
CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA(R) (C1 Esterase Inhibitor Subcutaneous [Human])
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Jul 2017
EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 21 Jul 2017
Lexicon Collaborator Ipsen Receives Positive CHMP Opinion For Xermelo(R) (Telotristat Ethyl)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 5 Jul 2017
Recordati Rare Diseases Introduces New PANHEMATIN(R) (Hemin for Injection) Dosage Strength for Treatment of Acute Intermittent Porphyria (AIP)
Biopharmaceuticals Product Launch

HSMN NewsFeed - 20 Jun 2017
ANI Pharmaceuticals Announces Launch of Diphenoxylate HCl and Atropine Sulfate Tablets
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 19 Jun 2017
FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA(R) (denosumab) To Include Multiple Myeloma Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jun 2017
NCCN Guidelines For Neuroendocrine Tumors Include XERMELO In Combination With Somatostatin Analog Therapy As A Recommended Treatment Option For Patients With Carcinoid Syndrome Diarrhea
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Jun 2017
Complete Efficacy and Long-Term Follow-Up Safety Results from SGX942 Phase 2 Oral Mucositis Clinical Trial to be Presented at the 2017 Multinational Association for Supportive Care in Cancer Conference
Biopharmaceuticals Oncology

HSMN NewsFeed - 13 Jun 2017
TECHLAB(R) Receives FDA 510(k) Clearance To Market E. HISTOLYTICA QUIK CHEK(TM) To Aid Clinicians In The Diagnosis Of Amebiasis Caused By The E. Histolytica Parasite
Diagnostics FDA

HSMN NewsFeed - 9 Jun 2017
Lexicon Pharmaceuticals Reports Positive Top-Line Results In Phase 3 inTandem3 Study For Sotagliflozin In Patients With Type 1 Diabetes
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 5 Jun 2017
New Data Presented at ASCO 2017 Finds IMBRUVICA(R) (ibrutinib) May Offer a More Targeted Approach to Chronic Lymphocytic Leukemia (CLL) Treatment than Chemotherapy Agent Chlorambucil in Treatment-Naïve Patients
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Jun 2017
BD Receives FDA 510(K) Clearance for Molecular Test for Harmful Intestinal Bacteria Causing Infectious Diarrhea
Diagnostics FDA

HSMN NewsFeed - 31 May 2017
Lilly Announces Phase 3 RANGE Urothelial Cancer Trial of CYRAMZA(R) (ramucirumab) Met Primary Endpoint, Improving Progression-Free Survival
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 May 2017
Array BioPharma and Bristol-Myers Squibb Announce Strategic Collaboration
Biopharmaceuticals Oncology

HSMN NewsFeed - 12 May 2017
Ardelyx Reports Successful Phase 3 T3MPO-1 Trial of Tenapanor in Patients with IBS-C
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 9 May 2017
FDA Grants BAVENCIO(R) (avelumab) Approval for a Common Type of Advanced Bladder Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 May 2017
Soligenix Receives FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 May 2017
Orexigen Therapeutics Announces Commercialization and Distributorship Arrangement with Navamedic ASA for Mysimba(R) (naltrexone HCl / bupropion HCl prolonged release) in Five Nordic Countries
Biopharmaceuticals Distribution

HSMN NewsFeed - 1 May 2017
NEUROTROPE Announces Positive Top-Line Results From Phase 2 Study of Bryostatin-1 for Moderate to Severe Alzheimer's Disease
Biopharmaceuticals Neurology

HSMN NewsFeed - 28 Apr 2017
Novartis Receives FDA Approval for Rydapt(R) in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) and Three Types of Systemic Mastocytosis (SM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Apr 2017
FDA Approves XATMEP(TM), the First and Only Ready-To-Use Methotrexate Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Apr 2017
Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study of Abemaciclib Demonstrated Superior Progression-Free Survival at Interim Analysis
Biopharmaceuticals Oncology

HSMN NewsFeed - 21 Apr 2017
Valeant's Patient Access And Pricing Committee Announces Pricing For SILIQ(TM) (Brodalumab) As The Lowest Priced Injectable Biologic For Moderate-To-Severe Plaque Psoriasis
Biopharmaceuticals Dermatology

HSMN NewsFeed - 17 Apr 2017
OncoMed’s Phase 2 Trial of Tarextumab in Small Cell Lung Cancer Does Not Meet Endpoints
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Apr 2017
AMAG Submits Supplemental New Drug Application to FDA for Makena(R) (Hydroxyprogesterone Caproate Injection) Auto-Injector for Subcutaneous Use
Biopharmaceuticals Devices Drug Delivery FDA

HSMN NewsFeed - 13 Apr 2017
RedHill Biopharma and IntelGenx Announce Marketing Approval of RIZAPORT(R) for Migraines in Luxembourg
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 4 Apr 2017
Teva Announces FDA Approval of AUSTEDO(TM) (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 28 Mar 2017
Introducing PROMETHEUS(R) IBcause(TM): Convenient All-in-One Diagnostic Test for Persistent Diarrhea
Diagnostics Gastroenterology Product Launch

HSMN NewsFeed - 24 Mar 2017
FDA Grants Approval for BAVENCIO(R) (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology FDA Product Launch

HSMN NewsFeed - 23 Mar 2017
New England Journal of Medicine Publishes Pivotal Phase III Data for CSL Behring's Subcutaneous C1-Esterase Inhibitor in HAE Patients
Biopharmaceuticals

HSMN NewsFeed - 20 Mar 2017
Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study of Abemaciclib Met Primary Endpoint of Progression-Free Survival
Biopharmaceuticals Oncology

HSMN NewsFeed - 15 Mar 2017
FDA Approves Merck’s KEYTRUDA(R) (pembrolizumab) for Adult and Pediatric Patients with Classical Hodgkin Lymphoma (cHL) Refractory to Treatment, or Who Have Relapsed After Three or More Prior Lines of Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Mar 2017
Pfizer Launches Zavicefta(TM) (ceftazidime-avibactam) in the U.K. and Germany, a New Antibiotic to Treat Complicated Infections Caused by Gram-Negative Bacteria
Biopharmaceuticals Product Launch

HSMN NewsFeed - 2 Mar 2017
BLINCYTO(R) (blinatumomab) Significantly Improved Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Compared To Chemotherapy
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Feb 2017
LYNPARZA(TM) (olaparib) Meets Primary Endpoint in Phase III Trial in BRCA-Mutated Metastatic Breast Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 Feb 2017
Valeant Receives FDA Approval Of SILIQ(TM) (Brodalumab) For Moderate-To-Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 8 Feb 2017
FDA Approves Amgen's Parsabiv(TM) (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 24 Jan 2017
FDA Grants Priority Review for Genentech’s Actemra(R) (Tocilizumab) Supplemental Biologics License Application for Giant Cell Arteritis, a Form of Vasculitis
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Jan 2017
Synergy Pharmaceuticals’ TRULANCE(TM) (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 20 Jan 2017
Bristol-Myers Squibb Provides Regulatory Update in First-line Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jan 2017
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Jan 2017
European Commission Amends Marketing Authorisation for RUCONEST(R) to Include Self-Administration
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Jan 2017
Study Results Published in the Journal of the American Medical Association Show Amgen's Parsabiv(TM) (Etelcalcetide) Significantly Reduced Serum Parathyroid Hormone in Adults With Secondary Hyperparathyroidism on Hemodialysis
Biopharmaceuticals

HSMN NewsFeed - 5 Jan 2017
Eisai Acquires All Global Development And Marketing Rights For Chronic Weight Management Treatment Lorcaserin HCI
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 27 Dec 2016
Shire Announces FDA Approval of Adynovate(R) for use in Children and Surgical Settings
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Dec 2016
Janssen Submits Application Seeking FDA Approval of STELARA(R) (Ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 14 Dec 2016
Health Canada approves STELARA(R) for the treatment of adults with moderately to severely active Crohn's disease
Biopharmaceuticals Gastroenterology Regulatory

HSMN NewsFeed - 9 Dec 2016
Biogen and AbbVie Receive Health Canada Approval of Once-Monthly ZINBRYTA(TM) (Daclizumab Beta) for Multiple Sclerosis
Biopharmaceuticals Nerurology Regulatory

HSMN NewsFeed - 8 Dec 2016
Pharming Announces Completion of Acquisition of All North American Commercialisation Rights for RUCONEST(R) From Valeant
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 28 Nov 2016
Conditional Approval from the European Commission to Treat Multiple Myeloma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Nov 2016
Allergan Acquires Chase Pharmaceuticals to Expand CNS R&D Pipeline and Build on Commitment to Alzheimer's Disease
Biopharmaceuticals Neurology Mergers & Acquisitions

HSMN NewsFeed - 22 Nov 2016
DARZALEX(R) (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Nov 2016
Boston Biomedical Announces Orphan Drug Designation for Napabucasin in Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Nov 2016
First Patient Enrolled in Mallinckrodt Phase 4 Trial of H.P. Acthar(R) Gel for Rheumatoid Arthritis
Biopharmaceuticals

HSMN NewsFeed - 11 Nov 2016
CHMP Adopts Positive Opinion to Include Self-administration for RUCONEST(R)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 11 Nov 2016
Bristol-Myers Squibb’s Opdivo(R) (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Nov 2016
IBRANCE(R) (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 8 Nov 2016
Orexigen Therapeutics Announces Commercialization and Distributorship Agreement with Valeant for Contrave(R) (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand
Biopharmaceuticals Distribution

HSMN NewsFeed - 31 Oct 2016
European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Oct 2016
Efficacy of Ofev(R) (nintedanib) Reinforced in Range of Patients with IPF in New Analyses Presented at CHEST
Biopharmaceuticals

HSMN NewsFeed - 14 Oct 2016
Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 12 Oct 2016
AMAG Pharmaceuticals Announces Achievement of Key Milestones in Next Generation Development Programs for Makena(R) and Feraheme(R)
Biopharmaceuticals

HSMN NewsFeed - 10 Oct 2016
First Positive Phase 3 Results in Adjuvant Setting for Renal Cell Carcinoma Show SUTENT(R) (sunitinib) Extended Disease Free Survival After Surgical Removal
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Sep 2016
AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA(R)) for Treatment of Marginal Zone Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Sep 2016
U.S. FDA Approves INVOKAMET(R) XR (Canagliflozin / Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 20 Sep 2016
KVK Tech Announces FDA-Approval of Lomaira(TM) (phentermine hydrochloride USP) 8 mg tablets, CIV, A Low-Cost, Low-Dose Phentermine That Can Be Used Up To Three Times Daily for Weight Reduction
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Sep 2016
Teva Strengthens Injectables Portfolio with the Launch of an Authorized Generic of Cubicin(R) (Daptomycin for Injection) in the United States
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 14 Sep 2016
European Commission Approves CABOMETYX(TM) (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 12 Sep 2016
Soligenix and SciClone Establish Regional Licensing Agreement for SGX942, a Novel Product Candidate for Oral Mucositis
Biopharmaceuticals Licensing

HSMN NewsFeed - 31 Aug 2016
Allergan and Adamas Announce Settlement with Amneal Related to NAMZARIC(R) Patent Litigation
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 31 Aug 2016
XALKORI(R) (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 29 Aug 2016
Regeneron and Sanofi Present Positive Phase 3 Investigational Data for Praluent(R) (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy at ESC Congress 2016
Biopharmaceuticals Cardiology

HSMN NewsFeed - 5 Aug 2016
Teva Announces Launch of Generic Gleevec(R) Tablets in the United States
Biopharmaceuticals Generics Oncology Product Launch

HSMN NewsFeed - 1 Aug 2016
Orexigen Completes Acquisition of All U.S. Rights to Contrave(R) and Launches U.S. Sales Organization
Biopharmaceuticals Acquisitions Product Launch

HSMN NewsFeed - 4 Jul 2016
European Commission Approves Extended Indication For Amgen's Kyprolis(R) (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma Patients
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 1 Jul 2016
Valeant Pharmaceuticals Announces New Licensing Arrangement For Brodalumab In Europe
Biopharmaceuticals Licensing

HSMN NewsFeed - 29 Jun 2016
AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA(R)) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options
Biopharmaceuticals

HSMN NewsFeed - 27 Jun 2016
GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex(R) (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome
Biopharmaceuticals

HSMN NewsFeed - 23 Jun 2016
Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ(R) (ceftazidime and avibactam)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Jun 2016
NUEDEXTA(R) Effective for Pseudobulbar Affect (PBA) in Patients with Alzheimer's Disease and other Dementias, Stroke and Traumatic Brain Injury
Biopharmaceuticals Neurology

HSMN NewsFeed - 8 Jun 2016
Orexigen Therapeutics Reports Favorable Markman Ruling in Contrave(R) Patent Litigation
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 31 May 2016
Allergan Receives FDA Approval of TEFLARO(R) (ceftaroline fosamil) for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 16 May 2016
Neos Therapeutics Announces U.S. Launch of Adzenys XR-ODT(TM) (Amphetamine Extended-Release Orally Disintegrating Tablet) for the Treatment of ADHD in Patients Six Years and Older
Biopharmaceuticals Product Launch

HSMN NewsFeed - 11 May 2016
Isaac J. Bright, MD, Joins Synthetic Biologics as Vice President, Corporate Development
Biopharmaceuticals Gastroenterology Personnel

HSMN NewsFeed - 9 May 2016
Theravance Biopharma Announces FDA Approval of Expanded Label for VIBATIV(R) (telavancin)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 May 2016
U.S. FDA Expands IMBRUVICA(R) (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 May 2016
Synthetic Biologics Appoints Deb Mathews, PharmD, as Vice President, Medical Affairs
Biopharmaceuticals Gastroenterology Personnel

HSMN NewsFeed - 27 Apr 2016
Novartis Receives Three FDA Breakthrough Therapy Designations for IlaristTo Treat Rare Types of Periodic Fever Syndromes
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Apr 2016
Impax Announces Availability of EMVERM(TM) (mebendazole) Chewable Tablets, 100 mg
Biopharmaceuticals Product Launch

HSMN NewsFeed - 11 Apr 2016
Adapt Pharma Names Mike Kelly President of U.S. Operations
Biopharmaceuticals Personnel

HSMN NewsFeed - 7 Apr 2016
Pharming Announces Adoption by the European Commission of the CHMP Recommendation to Change the Terms of the Marketing Authorisation for Ruconest(R)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 5 Apr 2016
Pfizer Announces Positive Top-Line Results from the First Phase 3 Trial of Investigational Tofacitinib in Adults with Psoriatic Arthritis
Biopharmaceuticals

HSMN NewsFeed - 4 Apr 2016
AbbVie Receives CHMP Positive Opinion for HUMIRA(R) (adalimumab) for the Treatment of Pediatric Patients, from Six Years of Age, with Moderately to Severely Active Crohn's Disease
Biopharmaceuticals Gastroenterology Regulatory

HSMN NewsFeed - 29 Mar 2016
Shire Wins Patent Trial Against Watson Concerning LIALDA(R)
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 24 Mar 2016
Pivotal Phase III Trial of enzalutamide Initiated in Metastatic Hormone Sensitive Prostate Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 18 Mar 2016
STELARA(R) Induced Clinical Response And Remission In Phase 3 Study For The Treatment Of Patients With Moderate To Severe Crohn's Disease Who Had Previously Failed Or Were Intolerant To Anti-TNF-Alpha Therapy
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 15 Mar 2016
Orexigen and Takeda Jointly Announce Orexigen's Acquisition of All Rights to CONTRAVE(R) in the United States
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 29 Feb 2016
Allergan Announces Receipt Of FDA Acceptable For Filing Letter For Generic XIFAXAN(R) ANDA
Biopharmaceuticals Generics Gastroenterology FDA

HSMN NewsFeed - 29 Feb 2016
CHMP Issues Positive Opinion for LONSURF(R) (trifluridine/tipiracil) for Refractory Metastatic Colorectal Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Feb 2016
FDA Accepts and Grants Priority Review for AVYCAZ(R) (ceftazidime and avibactam) Supplemental New Drug Application (sNDA)
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Feb 2016
Endo Announces Launch Of BELBUCA(TM) (Buprenorphine) Buccal Film For Chronic Pain Management
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 17 Feb 2016
Impax Receives FDA Approval for Generic Version of Adderall XR(R) (mixed salts of a single-entity amphetamine product) Capsules, CII
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Feb 2016
VIVLODEX(TM) Now Available in U.S. Pharmacies for the Management of Osteoarthritis Pain
Biopharmaceuticals Product Launch

HSMN NewsFeed - 16 Feb 2016
FDA Accepts Supplemental New Drug Application (sNDA) for TEFLARO(R) (ceftaroline fosamil)
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Feb 2016
Phase 3 Study of BLINCYTO(R) (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 Feb 2016
Dr. Reddy’s Laboratories Receives USFDA Tentative Approval for Zenavod(TM) (doxycycline) Capsules, 40 mg for the Treatment of Rosacea in Adults
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 28 Jan 2016
Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT(TM) (Amphetamine Extended-Release Orally Disintegrating Tablet) for the Treatment of ADHD in Patients 6 Years and Older
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 27 Jan 2016
Boehringer Ingelheim's Gilotrif(R) Demonstrated Superiority to Iressa(R) (Gefitinib) in Reducing the Risk of Disease Progression and Treatment Failure in First-Line Treatment of Patients with EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 25 Jan 2016
Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 25 Jan 2016
Boston Biomedical's Investigational Cancer Stem Cell Pathway Inhibitor, Napabucasin (BBI608), Featured at the ASCO 2016 Gastrointestinal Cancers Symposium
Biopharmaceuticals Oncology Gastroenterology

HSMN NewsFeed - 21 Jan 2016
Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE(R) (dalbavancin)
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Jan 2016
VIBERZI(TM) (eluxadoline) Phase III Trial Results Published in The New England Journal of Medicine
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 20 Jan 2016
Orphan Medicine Designation and European Medicines Agency Public Opinion Summary Published by EMA Regarding Alferon N Injection(R) as a Treatment of Middle East Respiratory Syndrome (MERS)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 16 Jan 2016
Novartis receives two new FDA approvals for Cosentyx(R) (secukinumab) to treat patients with ankylosing spondylitis and psoriatic arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jan 2016
Impax Receives Approval of EMVERM(TM) (mebendazole) Chewable Tablets, 100 mg
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Dec 2015
Oral REVLIMID(R) Plus Dexamethasone Granted Approval for Treatment of Patients with Newly Diagnosed Multiple Myeloma in Japan
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 14 Dec 2015
Allergan Announces U.S. Availability of VIBERZI(TM) (eluxadoline) for Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults
Biopharmaceuticals Gastroenterology Product Launch

HSMN NewsFeed - 10 Dec 2015
Lilly and Merck Expand Immuno-Oncology Collaboration Adding Abemaciclib and KEYTRUDA(R) Combination Trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Dec 2015
Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of BENDEKA(TM) (bendamustine hydrochloride) Injection
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Nov 2015
Pfizer Receives European Approval to Expand Use of XALKORI(R) (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Nov 2015
European Commission Approves Reconciliation of Indications for nivolumab Under the Opdivo(R) European Marketing Authorization Application
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Nov 2015
Bristol-Myers Squibb Announces U.S. Food and Drug Administration Approval for Opdivo (nivolumab) as a Single Agent for the Treatment of Patients with Previously Untreated BRAF Wild-Type Advanced Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 24 Nov 2015
European Commission Approves Amgen's BLINCYTO(R) (blinatumomab) for the Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 18 Nov 2015
Pfizer Reports Positive Topline Results from Phase 3 Trial Comparing XALKORI(R) (crizotinib) to Chemotherapy in Previously Untreated East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Biopharmaceuticals Oncology

HSMN NewsFeed - 13 Nov 2015
AbbVie Submits IMBRUVICA(R) (ibrutinib) Phase III Combination Data to U.S. FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Oct 2015
U.S. FDA Approves BELBUCA(TM) (buprenorphine) Buccal Film for Chronic Pain Management
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 23 Oct 2015
Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX(TM) - First Low Dose SoluMatrix(R) Meloxicam for Osteoarthritis Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Oct 2015
Merrimack Announces U.S. FDA Approval of ONIVYDE(TM) (irinotecan liposome injection) for the Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Oct 2015
Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Oct 2015
Synthetic Biologics Appoints Raymond Stapleton, PhD, as Senior Vice President, Manufacturing
Biopharmaceuticals Personnel

HSMN NewsFeed - 1 Oct 2015
BioMarin to Acquire Rights to Phenylketonuria (PKU) Franchise From Merck Serono
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 25 Sep 2015
Celgene’s VIDAZA(R) (Azacitidine for Injection) Receives Positive CHMP Opinion as New Treatment for Elderly Patients with Acute Myeloid Leukaemia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 14 Aug 2015
Baxter and Water Street Announce FDA Approval of CEFAZOLIN 2 Gram Premix
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Jul 2015
FDA approves Novartis drug Odomzo(R) (sonidegib) for locally advanced basal cell carcinoma (laBCC), a form of skin cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jul 2015
Valeant Pharmaceuticals Agrees To Acquire Amoun Pharmaceutical
Biopharmaceuticals Dermatology Mergers & Acquisitions

HSMN NewsFeed - 12 Jun 2015
FDA Approves Promacta(R) for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication
Biopharmaceuticals FDA

HSMN NewsFeed - 26 May 2015
Roche receives FDA clearance for the cobas(R) Cdiff Test to detect Clostridium difficile
Diagnostics FDA

HSMN NewsFeed - 18 May 2015
Actavis Launches NAMZARIC(TM) (memantine hydrochloride extended-release and donepezil hydrochloride), a Fixed-Dose Combination Therapy for the Treatment of Moderate to Severe Alzheimer's Disease
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 6 May 2015
EMD Serono Initiates Co-Promotion of XALKORI(R) (crizotinib) with Pfizer in the United States
Biopharmaceuticals Oncology Distribution

HSMN NewsFeed - 24 Apr 2015
Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Opdivo (nivolumab) for the Treatment of Advanced Melanoma in Both First-Line and Previously Treated Patients
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 6 Apr 2015
European Commission Approves Amgen's Vectibix(R) (panitumumab) As First-Line Treatment In Combination With FOLFIRI Chemotherapy For Metastatic Colorectal Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 19 Mar 2015
Coronado Biosciences Announces Exclusive Licensing Agreement With NeuPharma to Develop and Commercialize Novel Covalent 3rd Generation EGFR Inhibitors
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 19 Mar 2015
Daiichi Sankyo Signs Agreement With AstraZeneca To Co-Commercialize MOVANTIK In The US
Biopharmaceuticals

HSMN NewsFeed - 23 Feb 2015
Eiger BioPharmaceuticals Announces Presentation of Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib
Biopharmaceuticals

HSMN NewsFeed - 19 Feb 2015
FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf (Vemurafenib) in Advanced Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Feb 2015
Genentech’s Phase III Study of Gazyva(R) Showed Significant Benefit in Refractory Indolent Non-Hodgkin’s Lymphoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Feb 2015
FDA Approves New Dosing Option for CSL Behring's Hizentra(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jan 2015
The Medicines Company Receives CHMP Positive Opinions for Three Hospital Acute Care Products: KENGREXAL(TM) (cangrelor), ORBACTIV(TM) (oritavancin) and RAPLIXA(TM) (sealant powder)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 24 Dec 2014
Actavis and Adamas Announce FDA Approval of Namzaric(TM), a Fixed-Dose Combination of Memantine Extended-Release and Donepezil Hydrochloride
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 16 Dec 2014
Novartis gains FDA approval for Signifor(R) LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Dec 2014
Cepheid Receives FDA Clearance for Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus
Diagnostics FDA

HSMN NewsFeed - 25 Nov 2014
Valeant Pharmaceuticals Announces FDA Approval Of ONEXTON(TM) Gel For The Treatment Of Acne Vulgaris
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 3 Nov 2014
Salix and Pharming Announce the Launch of RUCONEST(R) in the U.S. for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE)
Biopharmaceuticals Product Launch

HSMN NewsFeed - 30 Oct 2014
U.S. FDA Approves Once-Daily XIGDUO(TM) XR Tablets for Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 16 Oct 2014
FDA Approves Boehringer Ingelheim's OFEV(R) (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Sep 2014
AMAG Pharmaceuticals to Acquire Lumara Health Maternal Health Business
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 19 Sep 2014
European Commission Grants Marketing Authorization for Gilead’s Zydelig(R) (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 27 Aug 2014
Ligand Partner GlaxoSmithKline Receives U.S. FDA Approval for Promacta(R)/Revolade(TM) For Use in Patients with Severe Aplastic Anemia
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Aug 2014
FDA Approves Boehringer Ingelheim's Striverdi(R) Respimat(R) (olodaterol) Inhalation Spray for Maintenance Treatment of COPD
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Aug 2014
European Commission Grants Orphan Drug Designation to Soliris(R) (eculizumab) for the Treatment of Patients with Myasthenia Gravis (MG)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 28 Jul 2014
Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE(TM) (doxycycline hyclate USP) Tablets, 150 mg and 75 mg
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jul 2014
European Medicines Agency (EMA) Issues Positive Opinion, Recommends Full Approval of IMBRUVICA(R) (ibrutinib) for Treatment of Two Blood Cancers
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 25 Jul 2014
Bayer and Onyx Pharmaceuticals Report Phase 3 Trial Results of NEXAVAR(R) (sorafenib) in Patients with Advanced Breast Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Jul 2014
Salix and Pharming Announce FDA Approval of RUCONEST(R) for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE)
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Jul 2014
Nexavar(R) (sorafenib tablets) now Approved in Canada for the Treatment of Differentiated Thyroid Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 27 Jun 2014
Vertex Receives European CHMP Positive Opinion for KALYDECO(TM) (ivacaftor) in Eight Non-G551D Gating Mutations
Biopharmaceuticals Regulatory

HSMN NewsFeed - 13 Jun 2014
Ligand Partner GSK Announces Results of Phase 3 PETIT2 Study of Eltrombopag (Promacta(TM)/Revolade(TM)) in Pediatric Patients with Chronic Immune Thrombocytopenia
Biopharmaceuticals

HSMN NewsFeed - 12 Jun 2014
SoluMatrix(R) Meloxicam Demonstrates Significant Efficacy at 30 Percent Lower Doses in the Treatment of Osteoarthritis
Biopharmaceuticals

HSMN NewsFeed - 11 Jun 2014
Lilly Announces Top-Line Results Of Phase III Hepatocellular Carcinoma Trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 11 Jun 2014
GSK and Theravance Announce Positive Data From Two Studies Evaluating the Efficacy and Safety of Incruse(TM) Ellipta(R) When Added to Relvar(R)/Breo(R) Ellipta(R) in Patients With COPD
Biopharmaceuticals

HSMN NewsFeed - 5 Jun 2014
ORBACTIV(TM) (Oritavancin) Phase 3 Trial Results Published in New England Journal of Medicine
Biopharmaceuticals

HSMN NewsFeed - 7 May 2014
The BD MAX(TM) Enteric Bacterial Panel Receives FDA Clearance to Detect the Most Common Causes of Bacterial Gastroenteritis
Diagnostics FDA

HSMN NewsFeed - 6 May 2014
FDA Approves EPANOVA for the Treatment of Adults with Severe Hypertriglyceridemia
Biopharmaceuticals FDA

HSMN NewsFeed - 5 May 2014
FDA Approves Conversion of Soliris(R) (eculizumab) Accelerated Approval in aHUS to Regular Approval for the Treatment of Patients with aHUS
Biopharmaceuticals FDA

HSMN NewsFeed - 1 May 2014
Merrimack Pharmaceuticals Announces MM-398 Achieves Primary Endpoint of Overall Survival in Phase 3 Trial in Post-Gemcitabine Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 30 Apr 2014
FDA Approves New Liquid Form Of Treatment For Patients With Acute Lymphoblastic Leukemia (ALL) As Part Of A Combination Regimen
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Apr 2014
Novartis gains FDA approval for Zykadia(TM), first therapy for patients with ALK+ NSCLC previously treated with the ALK inhibitor crizotinib
Biopharmaceuticals Oncology

HSMN NewsFeed - 22 Apr 2014
Pfizer Announces Positive Top-Line Results from Two Phase 3 Trials of Tofacitinib in Adults with Moderate-to-Severe Chronic Plaque Psoriasis
Biopharmaceuticals Dermatology

HSMN NewsFeed - 21 Apr 2014
Spectrum Pharmaceuticals Promotes and Appoints Joseph Turgeon as President and Chief Operating Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 11 Apr 2014
Gilead’s Sovaldi(R) Demonstrates Efficacy and Safety Among Chronic Hepatitis C Patients with Advanced Liver Disease
Biopharmaceuticals

HSMN NewsFeed - 3 Apr 2014
Astellas Announces European Regulatory Submission For XTANDI(R) (enzalutamide) Capsules For Chemotherapy-Naive Metastatic Prostate Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 25 Mar 2014
Exelixis Receives Approval for COMETRIQ(R) (Cabozantinib) in the European Union for Treatment of Progressive, Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 11 Mar 2014
Bayer and Onyx Report Phase 3 Study Results of NEXAVAR(R) (sorafenib) as Adjuvant Treatment for Patients with Liver Cancer Who Have Undergone Surgery or Local Ablation
Biopharmaceuticals Oncology

HSMN NewsFeed - 3 Mar 2014
U.S. FDA Approves Bydureon(R) Pen (exenatide extended-release for injectable suspension) for Once-Weekly Treatment of Adults with Type 2 Diabetes
Biopharmaceuticals Drug Delivery Endocrinology FDA

HSMN NewsFeed - 3 Mar 2014
Genentech Provides Update on Phase III Study of Onartuzumab in People with Specific Type of Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 20 Feb 2014
Bayer Initiates Phase III Trial of Stivarga(R) (regorafenib) Tablets in Patients with Colorectal Cancer after Resection of Liver Metastases
Biopharmaceuticals Oncology

HSMN NewsFeed - 15 Jan 2014
Antares Pharma Announces Availability of OTREXUP (Methotrexate) Injection for Subcutaneous Use to Treat Rheumatoid Arthritis (RA) and Psoriasis in Adults, and Polyarticular Idiopathic Arthritis (pJIA) in Children
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 14 Jan 2014
Ipsen to set up its own US oncology team for Somatuline(R) Depot(R) (lanreotide) Injection in neuroendocrine tumors
Biopharmaceuticals Oncology

HSMN NewsFeed - 13 Jan 2014
Galena Biopharma Acquires Mills Pharmaceuticals, LLC
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 8 Jan 2014
Ironwood Pharmaceuticals Announces Alignment of Workforce with Priority Growth Platforms
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 30 Dec 2013
Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Dec 2013
Takeda Announces Exclusive License and Option Agreement with Natrogen for Development of Natura-alpha for Inflammatory Bowel Disease
Biopharmaceuticals Gastroenterology Licensing

HSMN NewsFeed - 19 Dec 2013
Baxter Receives FDA Approval of FEIBA [Anti-Inhibitor Coagulant Complex] for Prophylactic Treatment of Hemophilia A&B Patients with Inhibitors
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Dec 2013
EMD Serono's Redesigned Fertility Pen Available for Distribution in US
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 9 Dec 2013
FDA Advisory Committee Recommends Approval of Takeda's Investigational Biologic Vedolizumab
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 20 Nov 2013
Health Canada Approves Genzyme's AUBAGIO(R) (teriflunomide), a Once-Daily, Oral Treatment for Relapsing Remitting Multiple Sclerosis
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 20 Nov 2013
Vertex Sells INCIVO(R) Product Royalty Rights for $152 Million
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 18 Nov 2013
Merck’s New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL(R) (posaconazole) Receives FDA Priority Review
Biopharmaceuticals FDA Regulatory

HSMN NewsFeed - 13 Nov 2013
Synergy Pharmaceuticals Initiates First Phase 3 Clinical Trial of Plecanatide in Patients with Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 11 Nov 2013
Shire to Acquire ViroPharma in Strategic Move to Strengthen Rare Disease Portfolio; Will Augment Already Strong Growth Prospects
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 8 Nov 2013
Eisai Announces Availability of ACIPHEX(R) Sprinkle(TM) (Rabeprazole Sodium) for Treatment of GERD in Children Ages 1 to 11
Biopharmaceuticals Gastroenterology Product Launch

HSMN NewsFeed - 8 Nov 2013
Pfizer Announces Top-Line Results Of Phase 3B/4 Study Of RAPAMUNE(R) (sirolimus) In Renal Transplant Recipients
Biopharmaceuticals

HSMN NewsFeed - 7 Nov 2013
Salix Pharmaceuticals to Acquire Santarus
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 5 Nov 2013
First and Only FDA-Approved, Non-Hormonal Treatment for Moderate to Severe Hot Flashes Now Available by Prescription in U.S. Pharmacies
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Nov 2013
FDA Approves Gazyva (Obinutuzumab) for People With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Oct 2013
Health Canada Approves A New Treatment Option For Patients With Gastrointestinal Stromal Tumours (GIST), A Rare Form Of Sarcoma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 15 Oct 2013
Given Imaging Announces Data Confirming PillCam(R) SB Can Improve Management and Outcomes in Patients With Crohn's Disease
Devices Gastroenterology

HSMN NewsFeed - 3 Oct 2013
Pfizer Inc. Announces FDA Approval of DUAVEE(TM) (conjugated estrogens/ bazedoxifene) for the Treatment of Moderate-to-Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause and the Prevention of Postmenopausal Osteoporosis [1]
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Oct 2013
Aubagio(R) Significantly Reduced Risk of New Clinical Relapse or MRI Lesion in Multiple Sclerosis Study
Biopharmaceuticals Neurology

HSMN NewsFeed - 13 Sep 2013
Alexion's Soliris(R) (eculizumab) Receives Marketing Approval in Japan for All Patients with aHUS
Biopharmaceuticals Regulatory

HSMN NewsFeed - 6 Sep 2013
Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Wockhardt
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 6 Sep 2013
U.S. Food and Drug Administration Approves ABRAXANE(R) in Combination with Gemcitabine as First-Line Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Sep 2013
CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Sep 2013
Aptalis Pharma(TM) Launches PYLERA(R) 10 Day Therapy PAK in the United States
Biopharmaceuticals Gastroenterology Product Launch

HSMN NewsFeed - 3 Sep 2013
Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Actavis
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 3 Sep 2013
Spectrum Pharmaceuticals Launches Marqibo(R) (vinCRIStine sulfate LIPOSOME injection) and Ships First Commercial Orders
Biopharmaceuticals Oncology Product Launch

HSMN NewsFeed - 30 Aug 2013
Bayer's Stivarga(R) (regorafenib) Tablets Approved in Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 26 Aug 2013
Galderma Receives FDA Approval of Mirvaso(R): the First and Only FDA-Approved Topical Treatment Specifically Developed and Indicated for the Facial Erythema of Rosacea
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 23 Aug 2013
ChemoCentryx Announces GlaxoSmithKline's Release of Top-Line Results From the SHIELD-1 Phase III Study of Vercirnon
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 22 Aug 2013
Horizon Pharma Announces Settlement of DUEXIS(R) Patent Litigation With Par Pharmaceutical
Biopharmaceuticals Generics Litigation Licensing

HSMN NewsFeed - 14 Aug 2013
Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Sandoz
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 18 Jul 2013
Celgene Will Discontinue Phase III ORIGIN(R) Trial in Previously Untreated Elderly Patients with B-Cell Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 Jul 2013
Alexion’s Soliris(R) (eculizumab) Receives Positive Opinion from the Committee for Orphan Medicinal Products for Treatment of Neuromyelitis Optica (NMO)
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 15 Jul 2013
Pfizer Provides Update on Global Regulatory Approvals and Launches of XELJANZ(R) (tofacitinib citrate) for the Treatment of Rheumatoid Arthritis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 2 Jul 2013
ARIAD Announces Marketing Authorization for Iclusig(R) (ponatinib) in the European Union
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 2 Jul 2013
FDA Grants Genentech’s Perjeta Regimen Priority Review for Use Before Surgery in HER2-Positive Early Stage Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Jun 2013
Genzyme Receives Positive CHMP Opinion for LEMTRADA(TM) (alemtuzumab) in Europe
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 24 Jun 2013
XTANDI(TM) (Enzalutamide) Authorized in the European Union for Advanced Prostate Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 7 Jun 2013
Eisai Announces Availability of BELVIQ(R) (lorcaserin HCl) CIV Tablets for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese
Biopharmaceuticals

HSMN NewsFeed - 5 Jun 2013
Astellas Signs Distribution Agreement With Tecnofarma For Enzalutamide In Latin America
Biopharmaceuticals Distribution

HSMN NewsFeed - 31 May 2013
Oral Anti-Cancer Therapy Pomalidomide Celgene Receives Positive CHMP Opinion as Treatment for Patients with Relapsed and Refractory Multiple Myeloma
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 May 2013
Astellas and Medivation Announce Submission of Application for Marketing Approval of Enzalutamide, an Oral Androgen Receptor Inhibitor, in Japan
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 May 2013
Study Finds 35 to 42 Percent Daily Cost Savings for Hospitals Using Flexi-Seal(R) Fecal Management System
Devices Wound Care

HSMN NewsFeed - 15 May 2013
Bayer Initiates Phase III Trial of Stivarga(R) (regorafenib) Tablets in Patients with Advanced Liver Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 13 May 2013
Optimer Pharmaceuticals Appoints Eric Sirota as Chief Operating Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 10 May 2013
Curis Announces Approval of Erivedge(R) in Australia
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 10 May 2013
Novartis drug Ilaris(R) approved by FDA to treat active systemic juvenile idiopathic arthritis, a serious form of childhood arthritis
Biopharmaceuticals. FDA

HSMN NewsFeed - 9 May 2013
Cornerstone Therapeutics Acquires Exclusive U.S. Marketing Rights to PERTZYE(R) (pancrelipase) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Cystic Fibrosis
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 3 May 2013
Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA(R) (efavirenz) in HIV-1 Infected Pediatric Patients
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 2 May 2013
Hyperion Therapeutics Exercises Option to Acquire Rights to BUPHENYL(R) and AMMONUL(R)
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 25 Mar 2013
XELJANZ(R) (tofacitinib citrate) Approved in Japan for the Treatment of Adults with Rheumatoid Arthritis (RA)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 28 Feb 2013
FDA Grants QIDP and Fast Track Designations for Cubist’s Late-Stage Antibiotic Candidates
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Feb 2013
Valeant Pharmaceuticals Acquires U.S. Rights to Targretin(R) from Eisai Inc.
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 15 Feb 2013
Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease
Biopharmaceuticals

HSMN NewsFeed - 14 Feb 2013
Santarus Announces Commercial Launch of UCERIS (budesonide) Extended Release Tablets
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 8 Feb 2013
Tranzyme Pharma Announces Exploration of Strategic Alternatives
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 5 Feb 2013
ZALTRAP(R) (ziv-aflibercept) Approved in the EU for Patients with Previously Treated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 31 Jan 2013
Pfizer Wins RAPAMUNE(R) Patent Case in Delaware District Court
Biopharmaceuticals Litigation

HSMN NewsFeed - 28 Jan 2013
Genzyme’s LEMTRADA(TM) (alemtuzumab) Application for MS Accepted for Review by the FDA
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 21 Jan 2013
Mallinckrodt Announces Approval of New Gablofen(R) Prefilled Syringe
Biopharmaceuticals Drug Delivery Neurology FDA

HSMN NewsFeed - 18 Jan 2013
Pfizer’s Bosutinib Receives Positive Opinion For Conditional Marketing Authorization From The Committee For Medicinal Products For Human Use For The Treatment Of Ph+ Chronic Myelogenous Leukemia With Resistance Or Intolerance To Prior Therapy In Europe
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 11 Jan 2013
Spectrum Pharmaceuticals Announces Promotion of Joseph Turgeon to Senior Vice President and Chief Commercial Officer as Company Builds on Recent Commercial Reorganization to Advance Growth and Market Penetration over the Next Five Years
Biopharmaceuticals Personnel

HSMN NewsFeed - 3 Jan 2013
Phase 3 DECISION Trial of Nexavar(R) (sorafenib) Meets Primary Endpoint of Improving Progression-Free Survival in Patients with Radioactive Iodine Refractory Differentiated Thyroid Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Jan 2013
FDA Approves Fulyzaq(TM) (Crofelemer) 125 mg Delayed-Release Tablets for the Symptomatic Relief of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy (ART)
Biopharmaceuticals FDA HIV/AIDS

HSMN NewsFeed - 21 Dec 2012
FDA Approves Gattex(R) (teduglutide [rDNA Origin]) for Injection for the Treatment of Adult Short Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 17 Dec 2012
Lexicon's Drug Candidate For Irritable Bowel Syndrome Receives Fast Track Status From The FDA
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 19 Nov 2012
Abacus Diagnostica Receives CE Mark for its Rapid Direct PCR Test for Toxigenic Clostridium Difficile
Diagnostics Regulatory

HSMN NewsFeed - 7 Nov 2012
U.S. Food and Drug Administration Approves Pfizer’s XELJANZ(R) (tofacitinib citrate) for Adults with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Methotrexate
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Oct 2012
Bayer's Stivarga(R) (regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Oct 2012
Teva Receives Approval For SYNRIBO(TM) (Omacetaxine Mepesuccinate) for Injection
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Oct 2012
Abbott Announces Three-Year Long-Term Data Evaluating Efficacy with HUMIRA(R) (Adalimumab) For Patients with Moderately to Severely Active Ulcerative Colitis
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 22 Oct 2012
Bayer's Investigational Riociguat Meets Primary Endpoint in Phase III Study in Patients with Pulmonary Arterial Hypertension (PAH)
Biopharmaceuticals

HSMN NewsFeed - 12 Oct 2012
FDA Approves Expanded Indication for ACTEMRA(R) in Rheumatoid Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Sep 2012
Bayer's Stivarga(R) (regorafenib) Tablets Approved by U.S. FDA for Treatment of Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Sep 2012
Sarepta Therapeutics' Lead Therapeutic Drugs for Ebola and Marburg Viruses Receive FDA Fast Track Designation
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Sep 2012
Pfizer To Present New Data in Lung And Kidney Cancers at The European Society For Medical Oncology 2012 Congress
Biopharmaceuticals Oncology

HSMN NewsFeed - 5 Sep 2012
Alvine Pharmaceuticals’ ALV003 Receives Fast Track Designation From the FDA for the Potential Treatment of Celiac Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Sep 2012
Vertex Announces Appointment of Stuart A. Arbuckle as Chief Commercial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 4 Sep 2012
Higher dose of Novartis drug Exelon(R) Patch approved by FDA for patients with mild to moderate Alzheimer's disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 29 Aug 2012
U.S. FDA Grants Priority Review of ZYTIGA(R) (abiraterone acetate) sNDA for Treatment of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 Aug 2012
Spectrum Pharmaceuticals Launches a Broad-based FUSILEV(R) Marketing Campaign; Increases Sales Force Footprint
Biopharmaceuticals Oncology

HSMN NewsFeed - 10 Aug 2012
Pfizer Reports Results From Phase 3 Study Of Torisel (temsirolimus) In Combination With Bevacizumab In Advanced Renal Cell Carcinoma (RCC)
Biopharmaceuticals Oncology

HSMN NewsFeed - 10 Aug 2012
Genentech Study Showed That Adding Avastin to Radiation and Chemotherapy Significantly Extended the Time People with an Aggressive Form of Brain Cancer Lived without Their Disease Worsening
Biopharmaceuticals Oncology

HSMN NewsFeed - 31 Jul 2012
Prometheus Launches New Monitoring Test To Help Guide Inflammatory Bowel Disease Management
Diagnostics Personalized Medicine Gastroenterology

HSMN NewsFeed - 27 Jul 2012
Genentech Reports Second Positive Study of ACTEMRA(R) Given by Subcutaneous Injection to Patients with Rheumatoid Arthritis
Biopharmaceuticals

HSMN NewsFeed - 24 Jul 2012
Optimer Pharmaceuticals Appoints Stephen Newman to Its Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 Jul 2012
Addition of Tarceva(R) (erlotinib) to Nexavar(R) (sorafenib) did not Provide Additional Benefit to Patients with Unresectable Liver Cancer Versus Nexavar alone in Phase 3 Trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 20 Jul 2012
Onyx Pharmaceuticals Receives FDA Accelerated Approval of Kyprolis(TM) (carfilzomib) for Injection
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Jul 2012
FDA Clears Cook Medical’s Evolution(R) Colonic Controlled-Release Stent
Devices Gastroenterology FDA

HSMN NewsFeed - 29 Jun 2012
Actelion Pharmaceuticals Announces U.S. Food and Drug Administration Approval of Supplemental New Drug Application for Second Generation VELETRI(R) (epoprostenol) for Injection
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jun 2012
Baxter Announces FDA Approval for GAMMAGARD LIQUID as a Treatment for Multifocal Motor Neuropathy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 22 Jun 2012
New Data From Phase III Study Showed That People With HER2-Positive Metastatic Breast Cancer Lived Longer With Genentech’s Perjeta
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Jun 2012
Pfizer Announces Positive Results From Phase 3 Study PROFILE 1007 Evaluating XALKORI(R) (crizotinib) In Previously Treated Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 12 Jun 2012
ConvaTec Introduces Enhanced Flexi-Seal(R) SIGNAL(R) FMS
Devices

HSMN NewsFeed - 4 Jun 2012
Phase 3 Data on Regorafenib Met Primary Endpoint Showing Significant Improvement in Progression-Free Survival in Patients with GIST
Biopharmaceuticals Oncology

HSMN NewsFeed - 4 Jun 2012
Phase III Data on Bayer's Regorafenib Met Primary Endpoint Showing Significant Improvement in Progression-Free Survival in Patients with GIST
Biopharmaceuticals Oncology

HSMN NewsFeed - 4 Jun 2012
Afatinib* delivers unprecedented first line efficacy in patients with EGFR mutation positive lung cancer in registration trial
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 Jun 2012
Aeolus Pharmaceuticals Announces AEOL 10150 Reduces Lung Damage After Neupogen(R) Treatment Following Radiation Exposure
Biopharmaceuticals Oncology

HSMN NewsFeed - 1 Jun 2012
Genzyme Reports Positive Top-Line Results of TOWER, a Pivotal Phase III Trial for AUBAGIO(TM)* (teriflunomide) in Relapsing Multiple Sclerosis
Biopharmaceuticals Neurology

HSMN NewsFeed - 31 May 2012
New Data Showed LIVALO(R) (pitavastatin) Met Primary Endpoint of LDL-C Reduction When Compared with Pravastatin
Biopharmaceuticals Cardiology

HSMN NewsFeed - 25 May 2012
Vertex Receives European CHMP Positive Opinion for KALYDECO(TM) (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 22 May 2012
Phase 3 MISSION trial of Nexavar (sorafenib) in Patients with Non-Small Cell Lung Cancer Did Not Meet Primary Endpoint of Improving Overall Survival
Biopharmaceuticals Oncology

HSMN NewsFeed - 16 May 2012
Genentech Will Report New Data on Important Progress for People with Advanced Cancers at ASCO 2012
Biopharmaceuticals Oncology

HSMN NewsFeed - 11 May 2012
Takeda Announces GEMINI II Trial of Vedolizumab in Patients with Moderately to Severely Active Crohn’s Disease Met Primary Endpoints of Improvement in Clinical Remission in Induction and Maintenance Phases
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 3 May 2012
Genentech Reports Positive Study of ACTEMRA Given by Subcutaneous Injection
Biopharmaceuticals

HSMN NewsFeed - 11 Apr 2012
Takeda to Acquire URL Pharma
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 10 Apr 2012
Santarus Appoints Alessandro E. Della Chà and Matthew W. Strobeck to Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 9 Apr 2012
Optimer Pharmaceuticals Announces Personnel Changes
Biopharmaceuticals Personnel

HSMN NewsFeed - 27 Mar 2012
Synta Announces Appointment of George Farmer, Ph.D., as Vice President, Corporate Development
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 Mar 2012
BYETTA(R) Approved for Use with Basal Insulin in Europe
Biopharmaceuticals Endocrinology Regulatory

HSMN NewsFeed - 12 Mar 2012
Synta Announces Appointment of Dvorit Samid, Ph.D., as Vice President, Medical Affairs
Biopharmaceuticals Personnel

HSMN NewsFeed - 2 Mar 2012
Genentech’s ACTEMRA(R) Monotherapy Showed Superior Improvement in Rheumatoid Arthritis Signs and Symptoms Versus Adalimumab Monotherapy
Biopharmaceuticals

HSMN NewsFeed - 15 Feb 2012
FDA Accepts Pfizer’s New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
Biopharmaceuticals Neurology

HSMN NewsFeed - 15 Feb 2012
Santarus Announces FDA Acceptance of UCERIS New Drug Application for Induction of Remission of Active Ulcerative Colitis
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 13 Feb 2012
Santarus Announces Initiation of Phase IIIb Study with UCERIS in Patients with Mild or Moderate Active Ulcerative Colitis
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 6 Feb 2012
Santarus Begins Promoting Cholesterol-Lowering Product FENOGLIDE
Biopharmaceuticals

HSMN NewsFeed - 1 Feb 2012
FDA approves Novartis drug Gleevec(R) label recommending extending treatment to three years for certain GIST patients after surgery
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Jan 2012
Curis Announces FDA Approval of Erivedge(TM) (vismodegib) Capsule as First Treatment for Advanced Basal Cell Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Jan 2012
U.S. Food And Drug Administration Approves Pfizer’s INLYTA(R) (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jan 2012
New FDA Approved Labeling For VYTORIN(R) (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 20 Jan 2012
Remicade(R) (Infliximab) Receives Positive Opinion From CHMP In Europe for Treatment of Ulcerative Colitis in Pediatric Patients
Biopharmaceuticals Gastroenterology Regulatory

HSMN NewsFeed - 12 Jan 2012
Chief Operating Officer Tessie M. Che Departing Company
Biopharmaceuticals Personnel

HSMN NewsFeed - 3 Jan 2012
CSL Behring Receives FDA Approval of Expanded Label on Berinert(R) for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 22 Dec 2011
Pfizer Reports Results From Three Phase 4 Studies Demonstrating EMBEDA(R) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII Impact On Drug Liking And Withdrawal Symptoms
Biopharmaceuticals

HSMN NewsFeed - 29 Nov 2011
Soliris(R) (eculizumab) Granted Marketing Authorization in Europe for Treatment of Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 17 Nov 2011
Pfizer’s Vyndaqel(R) (tafamidis) First Therapy Approved in the European Union for the Rare and Fatal Neurodegenerative Disease Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 9 Nov 2011
FDA Accepts Genentech’s New Drug Application For Vismodegib in Advanced Form of Skin Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Nov 2011
Lilly and Amylin Mutually Agree to End Diabetes Alliance and Transition Exenatide Responsibility to Amylin
Biopharmaceuticals

HSMN NewsFeed - 7 Nov 2011
IntraPace Introduces New Lead For abiliti(R) System Resulting in Reduced Procedure Time
Devices Regulatory

HSMN NewsFeed - 1 Nov 2011
FDA Approves Addition of Sustained Overall Survival Advantage (5-year follow-up) to Label for VELCADE(R) in Patients with Previously Untreated Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Oct 2011
Given Imaging Announces New Studies Validate Use of PillCam SB(R) to Detect and Monitor Crohn's Disease
Devices Gastroenterology

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