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  • COMPANY NEWS: Management tracks

    Boston Pharmaceuticals (Cambridge, Mass.) named Ian Sanderson CFO. He was CFO at Catabasis Pharmaceuticals Inc. (NASDAQ:CATB). Boston plans to in-license products that are in preclinical or early clinical testing, …

    Published on 7/22/2016
  • COMPANY NEWS: NICE recommends Lonsurf

    The U.K.'s NICE released final draft guidance recommending Lonsurf trifluridine/tipiracil from Servier (Neuilly-sur-Seine, France) to treat metastatic colorectal cancer in patients previously treated with or who are not…

    Published on 7/22/2016
  • COMPANY NEWS: Chronos, Shire in deal for preclinical CNS programs

    Chronos Therapeutics Ltd. (Oxford, U.K.) acquired from Shire plc (LSE:SHP; NASDAQ:SHPG) three preclinical programs focused on fatigue in multiple sclerosis, addictive behaviors and post-traumatic stress disorder. Shire …

    Published on 7/21/2016
  • COMPANY NEWS: FDA extends Zinplava review, requests more data

    Merck & Co. Inc. (NYSE:MRK) said FDA extended its review of a BLA for Zinplava bezlotoxumab (MK-6072) to prevent Clostridium difficile infection recurrence and requested additional data and analyses from the company's …

    Published on 7/21/2016
  • COMPANY NEWS: Galenica acquiring hyperkalemia play Relypsa

    Galenica Ltd. (SIX:GALN) said it will acquire Relypsa Inc. (NASDAQ:RLYP) for $32 per share in cash, which values the company at about $1.5 billion. Relypsa markets hyperkalemia treatment Veltassa patiromer, a high-…

    Published on 7/21/2016
  • COMPANY NEWS: Mylan, Biocon biosimilar Neulasta under EMA review

    Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for their proposed biosimilar pegfilgrastim to treat neutropenia. Amgen Inc. (NASDAQ:AMGN) markets the biosimilar's …

    Published on 7/21/2016
  • COMPANY NEWS: NICE now backs Alimta maintenance therapy

    In a final draft guidance, the U.K.'s NICE recommended Alimta pemetrexed from Eli Lilly and Co. (NYSE:LLY) as a maintenance treatment for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in…

    Published on 7/21/2016
  • COMPANY NEWS: AZ facing more generic Crestor competition

    On Tuesday, a federal judge in the U.S. District Court for the District of Columbia denied a motion from AstraZeneca plc (LSE:AZN; NYSE:AZN) seeking a temporary restraining order to prevent FDA from approving generic …

    Published on 7/20/2016
  • COMPANY NEWS: Breakthrough designation for SMA therapy boosts AveXis

    Gene therapy company AveXis Inc. (NASDAQ:AVXS) gained $4.64 (13%) to $40.65 on Wednesday after FDA granted breakthrough therapy designation to the company's AVXS-101 to treat spinal muscular atrophy (SMA) type 1.The …

    Published on 7/20/2016
  • COMPANY NEWS: FDA's oral Relistor approval triggers Progenics milestone

    Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) gained $1.20 (24%) to $6.14 on Wednesday after it and partner Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA approved oral Relistor methylnaltrexone…

    Published on 7/20/2016
  • COMPANY NEWS: Management tracks

    Critical Path Institute (C-Path) named Timothy Franson chairman, replacing Peter Corr. Franson will remain CMO of YourEncore (Indianapolis, Ind.).Women's health company Juniper Pharmaceuticals Inc. (NASDAQ:JNP) named …

    Published on 7/20/2016
  • COMPANY NEWS: Zafgen sinks after ending beloranib program

    Zafgen Inc. (NASDAQ:ZFGN) fell $3.51 (52%) to $3.24 on Wednesday after saying late Tuesday that it will discontinue development of subcutaneous beloranib (ZFN-440). Zafgen was studying the candidate to treat Prader-…

    Published on 7/20/2016
  • COMPANY NEWS: Celgene, Jounce in immuno-oncology deal

    Celgene Corp. (NASDAQ:CELG) obtained options to license multiple immuno-oncology programs from Jounce Therapeutics Inc. (Cambridge, Mass.), including lead candidate JTX-2011.Celgene is to pay Jounce $225 million up …

    Published on 7/19/2016
  • COMPANY NEWS: EC approves AstraZeneca's diabetes combo Qtern

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said the European Commission approved Qtern saxagliptin/dapagliflozin to improve glycemic control in adults with Type II diabetes for whom metformin and/or sulfonylurea, plus either …

    Published on 7/19/2016
  • COMPANY NEWS: FDA panel backs Valeant's brodalumab with risk plan

    On Tuesday, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of brodalumab (KHK4827) from Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) to treat …

    Published on 7/19/2016
  • COMPANY NEWS: Novartis discloses CRL for Neulasta biosimilar

    In 2Q16 results announced Tuesday, Novartis AG (NYSE:NVS; SIX:NOVN) said its Sandoz unit received a complete response letter from FDA for LA-EP2006, its proposed biosimilar of neutropenia drug Neulasta pegfilgrastim …

    Published on 7/19/2016
  • COMPANY NEWS: SciClone no longer on the block

    SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) fell $2.76 (21%) to $10.50 after it said it is no longer seeking acquirers and plans to remain an independent, publicly traded company. In February, the company said it hired …

    Published on 7/19/2016
  • COMPANY NEWS: Ziopharm says patient death was unrelated to treatment

    Ziopharm Oncology Inc. (NASDAQ:ZIOP) said a patient death disclosed on Friday was not related to treatment with gene therapy candidate Ad-RTS-hIL-12. The death, due to intracranial hemorrhage, was one of three Ziopharm …

    Published on 7/19/2016
  • COMPANY NEWS: China approves GSK's Cervarix

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said China FDA approved Cervarix to prevent cervical cancer. GSK said Cervarix is the first HPV vaccine approved in China. In early 2017, the company expects to launch the HPV …

    Published on 7/18/2016
  • COMPANY NEWS: EMA again reviewing Merck KGaA's MS therapy cladribine

    Merck KGaA (Xetra:MRK) said EMA accepted a resubmitted MAA for cladribine tablets to treat relapsing-remitting multiple sclerosis. Merck withdrew an MAA for the candidate in 2011 following a negative opinion from EMA's …

    Published on 7/18/2016
  • COMPANY NEWS: EMA reviewing Samsung Bioepis' Humira biosimilar

    Samsung Bioepis Co. Ltd. said EMA accepted for review an MAA for SB5, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NYSE:ABBV).Samsung Bioepis spokesperson Mingi Hyun declined to say whether the …

    Published on 7/18/2016
  • COMPANY NEWS: FDA, EMA reviewing Opdivo for head/neck cancer

    Bristol-Myers Squibb Co. (NYSE:BMY) said FDA and EMA accepted marketing applications for Opdivo nivolumab to treat relapsed squamous cell carcinoma of the head and neck (SCCHN). FDA granted Priority Review to an sBLA …

    Published on 7/18/2016
  • COMPANY NEWS: Management tracks

    Cancer and neurology company e-Therapeutics plc (LSE:ETX) said Malcolm Young resigned as CEO and a director. The company is searching for a replacement.Gene therapy company Calimmune Inc. (Tucson, Ariz.) promoted …

    Published on 7/18/2016
  • COMPANY NEWS: Elite's opioid gets complete response letter

    Elite Pharmaceuticals Inc. (OTCQB:ELTP) received an FDA complete response letter for an NDA for SequestOx (ELI-200), an abuse deterrent formulation of oxycodone and naltrexone to treat moderate to severe pain where the …

    Published on 7/15/2016
  • COMPANY NEWS: FDA reviewers mixed on brodalumab's safety

    In briefing documents released ahead of an advisory committee meeting, FDA reviewers focused on two main safety concerns with psoriasis compound brodalumab (KHK4827) from Valeant Pharmaceuticals International Inc. (TSX;…

    Published on 7/15/2016

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