;
Skip to main content
Home > The Daily Extra > Company News

Chronological Index of : Company News

 Current Issue
  • 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    The U.K.'s NICE issued draft guidance recommending Selincro nalmefene from H. Lundbeck A/S (CSE:LUN) to help reduce alcohol consumption in adults who are heavy drinkers but do not require immediate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
  • COMPANY NEWS: Shanghai Fosun terminating Sellas deal

    Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKSE:2196) terminated an October 2013 deal granting Sellas Life Sciences Group (Zurich, Switzerland) worldwide rights excluding China to two preclinical …

    Published on 7/2/2014
  • COMPANY NEWS: Zogenix planning abuse-deterrent Zohydro sNDA

    Zogenix Inc. (NASDAQ:ZGNX) jumped $0.37 (19%) to $2.36 on Wednesday after announcing plans to submit an sNDA to FDA in 2015 for a next-generation formulation of Zohydro ER hydrocodone capsules designed to be more …

    Published on 7/2/2014
  • COMPANY NEWS: EMA to review Merck's pembrolizumab for melanoma

    EMA accepted for review an MAA for pembrolizumab (MK-3475) from Merck & Co. Inc. (NYSE:MRK) to treat advanced melanoma. Merck declined to comment on when it expects a decision in Europe. A BLA for pembrolizumab is also …

    Published on 6/30/2014
  • COMPANY NEWS: Novartis withdraws Tasigna application

    Novartis AG (NYSE:NVS; SIX:NOVN) withdrew a European application to expand the label of Tasigna nilotinib to treat patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in whom …

    Published on 6/30/2014
  • COMPANY NEWS: CHMP backs Eylea for DME

    EMA's CHMP backed approval of Eylea aflibercept from Bayer AG (Xetra:BAYN) to treat visual impairment due to diabetic macular edema. Eylea is approved in the U.S. and EU to treat wet age-related macular edema (AMD) and …

    Published on 6/27/2014
  • COMPANY NEWS: CHMP backs Lilly's insulin glargine

    EMA's CHMP recommended marketing authorization of Abasria insulin glargine (LY2963016) from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and II diabetes. Lilly said the…

    Published on 6/27/2014
  • COMPANY NEWS: CHMP backs PET agent Vizamyl for Alzheimer's disease

    EMA's CHMP issued a positive opinion recommending approval of PET imaging agent Vizamyl [18F]-flutemetamol to detect beta amyloid neuritic plaque in adult patients with cognitive impairment being evaluated for Alzheimer…

    Published on 6/27/2014
  • COMPANY NEWS: FDA approves MannKind's inhaled insulin

    FDA approved a resubmitted NDA for Afrezza from MannKind Corp. (NASDAQ:MNKD) to improve glycemic control in Type I and II diabetics. Afrezza has a boxed warning on the risk of acute bronchospasm in patients with asthma …

    Published on 6/27/2014

< Previous   1  2  3  4  5  6  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993