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  • COMPANY NEWS: CHMP gives conditional nod to Chiesi's Holoclar

    EMA's CHMP recommended conditional marketing authorization for Holoclar from Chiesi Farmaceutici S.p.A. (Parma, Italy) to treat adults with moderate to severe limbal stem cell deficiency (LSCD) due to physical or …

    Published on 12/19/2014
  • COMPANY NEWS: CHMP puts Orexigen on first-to-market path in EU

    Orexigen Therapeutics Inc. (NASDAQ: OREX) stands to be first to market with a new obesity drug in Europe as EMA's CHMP adopted a positive opinion for Mysimba naltrexone/bupropion as an adjunct to reduced-calorie diet …

    Published on 12/19/2014
  • COMPANY NEWS: CHMP recommends Newron's safinamide for PD

    EMA's CHMP recommended marketing authorization of safinamide from Newron Pharmaceuticals S.p.A. (SIX:NWRN) and partner Zambon Co. S.p.A. (Bresso, Italy) as add-on therapy to a stable dose of a dopamine agonist for …

    Published on 12/19/2014
  • COMPANY NEWS: FDA approves AstraZeneca's Lynparza

    FDA granted accelerated approval to Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer, as …

    Published on 12/19/2014
  • COMPANY NEWS: FDA approves Cubist's Zerbaxa

    FDA approved Zerbaxa ceftolozane/tazobactam from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Zerbaxa was …

    Published on 12/19/2014
  • COMPANY NEWS: FDA strikes twice for Cerus

    Three days after FDA approved the Intercept Blood System for plasma, Cerus Corp. (NASDAQ:CERS) announced the agency approved the company's Intercept system for platelets. Cerus shares rose $0.25 to $6.41 on Friday; they…

    Published on 12/19/2014
  • COMPANY NEWS: Gilead, Ono in Btk inhibitor deal

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528) granted Gilead Sciences Inc. (NASDAQ:GILD) exclusive rights to develop and commercialize ONO-4059 outside of Japan, South Korea, Taiwan, China and countries in the Association of…

    Published on 12/19/2014
  • COMPANY NEWS: Lilly does second deal for Adocia's fast insulin

    Adocia S.A. (Euronext:ADOC) rose EUR 10.16 (37%) to EUR 37.40 after granting Eli Lilly and Co. (NYSE:LLY) exclusive, worldwide rights to BioChaperone Lispro to treat Type I and Type II diabetes.Adocia will receive $50 …

    Published on 12/19/2014
  • COMPANY NEWS: ContraVir obtains HBV candidate, investment from Chimerix

    Chimerix Inc. (NASDAQ:CMRX) granted ContraVir Pharmaceuticals Inc. (OTCBB:CTRV) exclusive, worldwide rights to develop and commercialize CMX157 for HBV and HIV. Chimerix will receive up front 120,000 shares of ContraVir…

    Published on 12/18/2014
  • COMPANY NEWS: Merck acquires OncoEthix for BET inhibitor

    Merck & Co. Inc. (NYSE:MRK) will pay $110 million up front to acquire cancer play OncoEthix S.A. (Lausanne, Switzerland). OncoEthix shareholders are eligible for a further $265 million in milestones.OncoEthix's lead …

    Published on 12/18/2014
  • COMPANY NEWS: Novo Nordisk, Xencor in antibody deal

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) and Xencor Inc. (NASDAQ:XNCR) partnered to use Xencor's XmAb bispecific Fc domain technology and XmAb immune inhibitor technology to develop antibodies against an undisclosed Novo …

    Published on 12/18/2014
  • COMPANY NEWS: Roche to acquire Dutalys

    Roche (SIX:ROG; OTCQX:RHHBY) will acquire antibody developer Dutalys GmbH (Vienna, Austria) for $133.8 million in cash up front. Dutalys' shareholders are eligible for $355 million in undisclosed milestones. Roche …

    Published on 12/18/2014
  • COMPANY NEWS: SciClone will channel Medicines Co. drugs in China

    The Medicines Co. (NASDAQ:MDCO) granted SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) exclusive rights to promote cardiovascular drugs Cleviprex clevidipine and Angiomax bivalirudin in China.SciClone, which sells to a …

    Published on 12/18/2014
  • COMPANY NEWS: Takeda taps ex-Sanofi exec Plump as CMSO

    Takeda Pharmaceuticals Co. Ltd. (Tokyo:4502) named Andrew Plump as a new corporate officer and Chief Medical and Scientific Officer designate.Plump will join Takeda on Feb. 1, replacing CMSO Tadataka Yamada after a …

    Published on 12/18/2014
  • COMPANY NEWS: FDA approves Cerus' Intercept for plasma

    Cerus Corp. (NASDAQ:CERS) jumped $1.08 (23%) to $5.86 on Wednesday after FDA approved the company's Intercept Blood System for plasma. The plasma pathogen inactivation system using the light-activated compound …

    Published on 12/17/2014
  • COMPANY NEWS: FDA will review Apotex's Neulasta biosimilar

    Apotex Inc. (Toronto, Ontario) said FDA accepted for filing a regulatory application for a biosimilar of pegfilgrastim. The application was submitted under the 351(k) abbreviated approval pathway under the Biosimilar …

    Published on 12/17/2014
  • COMPANY NEWS: Flexus discloses financings

    Cancer immunotherapy play Flexus Biosciences Inc. (San Carlos, Calif.) said it has raised $38 million in two rounds of funding. Kleiner Perkins Caufield & Byers incubated the company and led its $13 million series A in …

    Published on 12/17/2014
  • COMPANY NEWS: Halozyme jumps on J&J partnership

    Halozyme Therapeutics Inc. (NASDAQ:HALO) added $1.01 (13%) to $8.65 on Wednesday after announcing a collaboration with the Janssen unit of Johnson & Johnson (NYSE:JNJ) to use the biotech's Enhanze rHuPH20 technology to …

    Published on 12/17/2014
  • COMPANY NEWS: Pozen falls on second complete response

    Pozen Inc. (NASDAQ:POZN) lost $0.93 (10%) to $8.10 after FDA issued a second complete response letter for the company's Yosprala combinations of aspirin and omeprazole for the secondary prevention of cardiovascular …

    Published on 12/17/2014
  • COMPANY NEWS: Shire borrows $2.1B, reportedly eyes NPS

    Shire plc (LSE:SHP; NASDAQ:SHPG) secured $2.1 billion in a revolving loan agreement amid speculation it was preparing to make an acquisition.Both Shire and NPS Pharmaceuticals Inc. (NASDAQ:NPSP) declined to comment on …

    Published on 12/17/2014
  • COMPANY NEWS: FDA approves Ipsen's Somatuline Depot for GEP-NETs

    FDA approved an sNDA under Priority Review for Somatuline Depot lanreotide acetate (ITM-014) from Ipsen Group (Euronext:IPN; Pink:IPSEY) to treat rare gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Ipsen …

    Published on 12/16/2014
  • COMPANY NEWS: Galapagos regains GLPG1205 rights from J&J

    Galapagos N.V. (Euronext:GLPG; Pink:GLPYY) said Johnson & Johnson (NYSE:JNJ) returned all rights to compounds targeting G protein-coupled receptor 84 (GPR84) covered under the companies' partnership, including GLPG1205,…

    Published on 12/16/2014
  • COMPANY NEWS: IQWiG finds no additional Eylea benefit in DME

    The German Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment that an added benefit was not proven for Eylea aflibercept from Bayer AG (Xetra:BAYN) for visual impairment due to …

    Published on 12/16/2014
  • COMPANY NEWS: Veloxis sues FDA over tacrolimus delay

    Veloxis Pharmaceuticals A/S (CSE:VELO) filed suit in the U.S. District Court for the District of Columbia seeking an order requiring FDA to grant final approval to immunosuppressant Envarsus XR tacrolimus and allow …

    Published on 12/16/2014
  • COMPANY NEWS: Altshuler leaves Broad Institute for Vertex

    David Altshuler will leave the Broad Institute of MIT and Harvard to join Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) as EVP of global research and CSO, effective early next year. He will replace Peter Mueller, who …

    Published on 12/15/2014

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