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Chronological Index of : Company News

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  • COMPANY NEWS: NICE now backs Tecfidera in RRMS subgroup

    The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tecfidera dimethyl fumarate from Biogen Idec Inc. (NASDAQ:BIIB) to treat relapsing-remitting multiple sclerosis (RRMS) in a subgroup of patients …

    Published on 7/11/2014
  • COMPANY NEWS: Shire confirms AbbVie meeting

    Shire plc (LSE:SHP; NASDAQ:SHPG) confirmed it held a meeting with representatives of AbbVie Inc. (NYSE:ABBV), but strongly advised shareholders to take no action in relation to AbbVie's proposal to acquire Shire in a …

    Published on 7/11/2014
  • COMPANY NEWS: Bristol-Myers to submit BLA for nivolumab in melanoma

    Bristol-Myers Squibb Co. (NYSE:BMY) said it plans to submit a BLA to FDA this quarter for Opdivo nivolumab to treat previously treated advanced melanoma. The pharma has already started a rolling BLA for nivolumab as …

    Published on 7/10/2014
  • COMPANY NEWS: France moves to reimburse off-label Avastin

    The French National Assembly voted to issue a temporary recommendation for use (RTU) for Avastin bevacizumab in wet age-related macular degeneration (AMD) and allow reimbursement in the indication. An RTU is issued for …

    Published on 7/10/2014
  • COMPANY NEWS: Jounce names Murray CEO

    Cancer immunotherapy play Jounce Therapeutics Inc. (Cambridge, Mass.) hired Richard Murray as CEO. Murray, formerly SVP of biologics and vaccines research at Merck & Co. Inc. (NYSE:MRK), succeeds interim CEO Cary …

    Published on 7/10/2014
  • COMPANY NEWS: Astellas submits isavuconazole NDA

    Astellas Pharma Inc. (Tokyo:4503) submitted an NDA to FDA for isavuconazole to treat invasive aspergillosis and invasive mucormycosis (zygomycosis). The broad spectrum water-soluble azole antifungal has Qualified …

    Published on 7/9/2014
  • COMPANY NEWS: Baxter acquires AesRx, gains NCATS-funded compound

    Baxter International Inc. (NYSE:BAX) acquired Orphan disease play AesRx LLC (Newton, Mass.), gaining Aes-103, which AesRx was developing with funding from NIH's National Center for Advancing Translational Sciences (…

    Published on 7/9/2014
  • COMPANY NEWS: Court grants preliminary injunction lifting Zohydro restrictions

    The U.S. District Court in Massachusetts granted a preliminary injunction that lifted some state restrictions for prescribing pain drug Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX). The injunction …

    Published on 7/9/2014
  • COMPANY NEWS: NICE backs Lundbeck's Selincro for alcohol consumption

    The U.K.'s NICE issued draft guidance recommending Selincro nalmefene from H. Lundbeck A/S (CSE:LUN) to help reduce alcohol consumption in adults who are heavy drinkers but do not require immediate detoxification. The …

    Published on 7/9/2014
  • COMPANY NEWS: Salix, Cosmo subsidiary to merge

    Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) will merge with an Irish subsidiary of partner Cosmo Pharmaceuticals S.p.A. (SIX:COPN) in a stock deal that will give Cosmo about a 20% stake in Salix. Salix will become a …

    Published on 7/9/2014
  • COMPANY NEWS: FDA approves Anacor's Kerydin

    FDA approved Kerydin tavaborole from Anacor Pharmaceuticals Inc. (NASDAQ:ANAC) to treat onychomycosis of the toenails. The company said Kerydin, its first approved product, is the first topical oxaborole antifungal …

    Published on 7/8/2014
  • COMPANY NEWS: HealthCare Royalty, Supernus in Orenitram royalty deal

    HealthCare Royalty Partners paid Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) $30 million in cash for an undisclosed portion of milestones and royalties Supernus is eligible to receive from United Therapeutics Corp. (…

    Published on 7/8/2014
  • COMPANY NEWS: Priority Review for Purdue's abuse-deterrent hydrocodone

    Purdue Pharma L.P. (Stamford, Conn.) said FDA accepted and granted Priority Review to an NDA for a once-daily, abuse-deterrent formulation of hydrocodone bitartrate extended release (ER) to treat chronic pain. The PDUFA…

    Published on 7/8/2014
  • COMPANY NEWS: EC approves GSK's Mekinist as monotherapy

    The European Commission approved Mekinist trametinib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) as monotherapy to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation. The pharma said it is …

    Published on 7/7/2014
  • COMPANY NEWS: Gruenenthal submits Zalviso MAA

    Gruenenthal Group (Aachen, Germany) submitted an MAA to EMA for Zalviso to treat moderate to severe acute pain in adults in a medically supervised environment. The submission triggers a $5 million milestone payment to …

    Published on 7/7/2014
  • COMPANY NEWS: Novartis, UPenn get breakthrough for CAR therapy

    Novartis AG (NYSE:NVS; SIX:NOVN) and partner University of Pennsylvania said FDA granted breakthrough therapy designation for CTL019 to treat relapsed/refractory adult and pediatric acute lymphoblastic leukemia (ALL). …

    Published on 7/7/2014
  • COMPANY NEWS: Yabao gains Chinese rights to Lilly diabetes compound

    Eli Lilly and Co. (NYSE:LLY) granted Yabao Pharmaceutical Group Co. Ltd. (Shanghai:600351) Chinese rights to develop and commercialize Lilly's diabetes compound LY2608204. The glucokinase (GCK; GK) activator has …

    Published on 7/7/2014
  • COMPANY NEWS: EC approves Arzerra for first-line CLL

    The European Commission approved a label expansion for Arzerra ofatumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to include first-line treatment of chronic lymphocytic…

    Published on 7/3/2014
  • COMPANY NEWS: FDA accepts NDA for InterMune's pirfenidone

    FDA accepted for review a resubmitted NDA from InterMune Inc. (NASDAQ:ITMN) for pirfenidone to treat idiopathic pulmonary fibrosis (IPF). The agency designated the NDA a Class 2 resubmission, with a Nov. 23 PDUFA date, …

    Published on 7/3/2014
  • COMPANY NEWS: FDA approves Spectrum's belinostat

    FDA granted accelerated approval to Beleodaq belinostat from Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL). The approval came nearly a month ahead of the …

    Published on 7/3/2014
  • COMPANY NEWS: UCB, Dermira in Cimzia deal

    UCB Group (Euronext:UCB) granted Dermira Inc. (Redwood City, Calif.) exclusive rights to develop Cimzia certolizumab pegol to treat psoriasis in the U.S., Canada and the EU and exclusive rights to commercialize the …

    Published on 7/3/2014
  • COMPANY NEWS: Bind, Amgen end Accurin deal

    Bind Therapeutics Inc. (NASDAQ:BIND) and Amgen Inc. (NASDAQ:AMGN) terminated a 2013 deal to develop and commercialize an Accurin therapeutic for solid tumor indications selected by Amgen. An Accurin is a selective and …

    Published on 7/2/2014
  • COMPANY NEWS: Jazz reacquires rights in Americas for defibrotide

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) will reacquire from Sigma-Tau Group (Pomezia, Italy) rights in the Americas for defibrotide for $75 million up front. Sigma-Tau had rights to the product from Gentium S.p.A., which…

    Published on 7/2/2014
  • COMPANY NEWS: Nicox to acquire Aciex

    Nicox S.A. (Euronext:COX) announced it will acquire ophthalmic play Aciex Therapeutics Inc. (Westborough, Mass.) in a stock deal worth up to $120 million. Aciex shareholders will receive an upfront stock payment of $65 …

    Published on 7/2/2014
  • COMPANY NEWS: Priority Review for Boehringer's nintedanib

    FDA accepted and granted Priority Review to an NDA from Boehringer Ingelheim GmbH (Ingelheim, Germany) for nintedanib (BIBF 1120) to treat idiopathic pulmonary fibrosis (IPF). Boehringer declined to disclose the PDUFA …

    Published on 7/2/2014

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