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  • COMPANY NEWS: Breakthrough designation for AZ's Lynparza in CRPC

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA granted breakthrough therapy designation to Lynparza olaparib as monotherapy to treat metastatic castration-resistant prostate cancer. The designation covers CRPC patients …

    Published on 1/28/2016
  • COMPANY NEWS: FDA approves Merck's HCV combo

    FDA approved Zepatier grazoprevir/elbasvir (MK-5172/MK-8742) from Merck & Co. Inc. (NYSE:MRK) with or without ribavirin to treat HCV genotypes 1 and 4 in adults. Merck said Thursday it would launch the drug within seven…

    Published on 1/28/2016
  • COMPANY NEWS: Genentech in-licenses Amgen's AMG 282

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) received exclusive global rights from Amgen Inc. (NASDAQ:AMGN) to AMG 282, an antibody against IL-1 receptor-like 1 (IL1RL1; ST2). The antibody prevents IL-33 from…

    Published on 1/28/2016
  • COMPANY NEWS: Neos rises after ADHD approval

    Neos Therapeutics Inc. (NASDAQ:NEOS) gained $3.96 (42%) to $13.38 on Thursday after FDA approved Adzenys XR-ODT (NT-0202) to treat ADHD in patients aged six and older. Chief Commercial Officer Thomas McDonnell said Neos…

    Published on 1/28/2016
  • COMPANY NEWS: Priority Review for Exelixis' cabozantinib in RCC

    Exelixis Inc. (NASDAQ:EXEL) said FDA granted Priority Review to an NDA for a tablet formulation of cabozantinib (XL184) as second-line therapy to treat advanced renal cell carcinoma. Its PDUFA date is June 22. Exelixis …

    Published on 1/28/2016
  • COMPANY NEWS: Massachusetts AG presses Gilead on HCV pricing

    In a letter to Gilead Sciences Inc. (NASDAQ:GILD) Chairman and CEO John Martin, Massachusetts Attorney General Maura Healey said her office is "considering whether Gilead's pricing strategy" for its HCV drugs Sovaldi …

    Published on 1/27/2016
  • COMPANY NEWS: Merck, CRT in deal for PRMT5 inhibitors

    Merck & Co. Inc. (NYSE:MRK) partnered with Cancer Research Technology Ltd. to develop inhibitors of protein arginine methyltransferase 5, which the companies said have potential to treat cancer and non-cancer blood …

    Published on 1/27/2016
  • COMPANY NEWS: Priority Review for Merck's bezlotoxumab

    Merck & Co Inc. (NYSE:MRK) said FDA accepted for filing and granted Priority Review to a BLA for bezlotoxumab (MK-6072) to treat recurrent Clostridium difficile infection. Its PDUFA date is July 23.Merck said EMA is …

    Published on 1/27/2016
  • COMPANY NEWS: NICE backs five cancer drugs, spurns Cyramza

    The U.K.'s NICE recommended a quintet of cancer drugs, including reversing a prior decision on Farydak panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN); however, the agency snubbed stomach cancer compound Cyramza …

    Published on 1/26/2016
  • COMPANY NEWS: FDA accepts BLA for Amgen's Humira biosimilar

    Amgen Inc. (NASDAQ:AMGN) said FDA accepted for review a BLA for ABP 501, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV). Its action date under the Biosimilar User Fee Act (BsUFA) is Sept. 25.Amgen said …

    Published on 1/25/2016
  • COMPANY NEWS: FDA reviewing Valeant's brodalumab

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA accepted a BLA for brodalumab (KHK4827) to treat moderate to severe plaque psoriasis. The PDUFA date for the human IgG2 mAb against IL-17 receptor…

    Published on 1/25/2016
  • COMPANY NEWS: Management tracks

    Neurology play Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) named James Owen CMO and SVP of clinical development. He was VP of U.S. clinical affairs at H. Lundbeck A/S (CSE:LUN). Cancer play Clovis Oncology Inc. (NASDAQ:…

    Published on 1/25/2016
  • COMPANY NEWS: Shire resubmits lifitegrast NDA

    Shire plc (LSE:SHP; NASDAQ:SHPG) resubmitted an NDA to FDA for lifitegrast (SHP606) to treat signs and symptoms of dry eye. The company had received a complete response letter from FDA in October requesting an …

    Published on 1/25/2016
  • COMPANY NEWS: Management tracks

    Cardiovascular play Amarin Corp. plc (NASDAQ:AMRN) named Craig Granowitz CMO. Granowitz was SVP and head of global medical affairs and global human health at Merck & Co. Inc. (NYSE:MRK). Amarin also promoted Steve …

    Published on 1/22/2016
  • COMPANY NEWS: HealthCare Ventures' Leap makes debut

    HealthCare Ventures combined portfolio companies HealthCare Pharmaceuticals Inc. and GITR Inc. into newco Leap Therapeutics Inc. (Cambridge, Mass.). Leap also disclosed clinical efficacy data for lead program DKN-01 to …

    Published on 1/21/2016
  • COMPANY NEWS: Janssen joins U.K. schools in phenotype initiative

    The University of Dundee, University of Edinburgh and University of Oxford launched the Phenomics Discovery Initiative (PDi), which intends to develop phenotypic assays for drug discovery. The Janssen Pharmaceutica N.V.…

    Published on 1/21/2016
  • COMPANY NEWS: Management tracks

    Oncology company Affimed N.V. (NASDAQ:AFMD) named Joerg Windisch COO. Windisch was CSO at the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN).Emergent BioSolutions Inc. (NYSE:EBS) named a management team for planned …

    Published on 1/21/2016
  • COMPANY NEWS: New approvals for Amgen's Kyprolis

    Amgen Inc. (NASDAQ:AMGN) said FDA approved an sNDA for Kyprolis carfilzomib to treat relapsed multiple myeloma (MM) in combination with dexamethasone or Revlimid lenalidomide plus dexamethasone in patients who have …

    Published on 1/21/2016
  • COMPANY NEWS: EC approves UCB's Briviact

    UCB Group (Euronext:UCB) said the European Commission approved Briviact brivaracetam as an adjunct therapy to treat partial-onset seizures in epileptic patients aged 16 and older. The approval is the first worldwide for…

    Published on 1/20/2016
  • COMPANY NEWS: FDA postpones meeting to discuss Sarepta's eteplirsen

    Citing forecasts of inclement weather in Washington, FDA postponed the planned Jan. 22 meeting of its Peripheral and Central Nervous System Drugs Advisory Committee to discuss an NDA for eteplirsen (AVI-4658) from …

    Published on 1/20/2016
  • COMPANY NEWS: Medicines Co. gains on takeout rumors

    The Medicines Co. (NASDAQ:MDCO) gained $4.55 (14%) to $36.06 on Wednesday, giving it a market cap of $2.5 billion, after media reports said the company is exploring a sale. Spokesperson Robert Laverty declined to …

    Published on 1/20/2016
  • COMPANY NEWS: EC approves first Enbrel biosimilar

    The European Commission approved Benepali etanercept (SB4) from Samsung Bioepis Co. Ltd., a biosimilar of Enbrel etanercept. Samsung Bioepis said the drug is the first Enbrel biosimilar, and the first subcutaneous …

    Published on 1/19/2016
  • COMPANY NEWS: Lilly submits baricitinib NDA, triggers Incyte milestone

    Eli Lilly and Co. (NYSE:LLY) submitted an NDA to FDA for baricitinib (LY3009104) to treat moderate to severe rheumatoid arthritis, triggering a $35 million milestone payment to Incyte Corp. (NASDAQ:INCY) from the pharma…

    Published on 1/19/2016
  • COMPANY NEWS: Management tracks

    Drug delivery play Enteris BioPharma Inc. (Boonton, N.J.) named Joel Tune CEO and promoted Paul Shields to COO from VP of operations. Tune was Enteris' executive chairman and an independent consultant.The Akcea …

    Published on 1/19/2016
  • COMPANY NEWS: MediciNova's Krabbe therapy gets rare pediatric designation

    MediciNova Inc. (NASDAQ:MNOV; JASDAQ:4875) said FDA granted rare pediatric disease designation to ibudilast (MN-166), its candidate to treat globoid cell leukodystrophy, or Krabbe disease. The designation is among the …

    Published on 1/19/2016

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