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  • COMPANY NEWS: AstraZeneca, Isis expand antisense collaboration

    AstraZeneca plc (LSE:AZN; NYSE:AZN) and Isis Pharmaceuticals Inc. (NASDAQ:ISIS) partnered to discover and develop antisense therapeutics against undisclosed targets for cardiovascular, metabolic and renal diseases.Isis …

    Published on 8/3/2015
  • COMPANY NEWS: BeiGene gets CFDA approval to conduct clinical trial

    BeiGene Co. Ltd. (Beijing, China) said China FDA approved a clinical trial application (CTA) for BGB-283. The small molecule, second-generation BRAF inhibitor is BeiGene's first candidate to receive a CTA approval.…

    Published on 8/3/2015
  • COMPANY NEWS: BioMarin revenues rise as it awaits DMD meeting

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) reported earnings and said it is planning an early 2016 launch for drisapersen, its therapy for Duchenne muscular dystrophy amenable to exon 51 skipping. The antisense …

    Published on 8/3/2015
  • COMPANY NEWS: Clovis submits NDA, MAA for rociletinib

    Clovis Oncology Inc. (NASDAQ:CLVS) submitted an NDA to FDA and an MAA to EMA for rociletinib (AVL-301) to treat non-small cell lung cancer (NSCLC) in patients who have the EGFR T790M mutation and have been previously …

    Published on 8/3/2015
  • COMPANY NEWS: Pfizer gets U.S. rights to Synthon's generic Copaxone

    Synthon B.V. (Nijmegen, the Netherlands) granted Pfizer Inc. (NYSE:PFE) exclusive U.S. commercialization rights to a generic version of glatiramer acetate for relapsing/remitting multiple sclerosis. Teva Pharmaceutical …

    Published on 8/3/2015
  • COMPANY NEWS: Shire buys Foresight for $300M

    Shire plc (LSE:SHP; NASDAQ:SHPG) acquired ophthalmic play Foresight Biotherapeutics Inc. (New York, N.Y.) for $300 million in cash. The deal gives Shire global rights to FST-100, an ophthalmic formulation of …

    Published on 8/3/2015
  • COMPANY NEWS: Teva buying majority stake in Immuneering

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) will acquire a 51% stake in computational genomic analysis company Immuneering Corp. (Cambridge, Mass.). Teva spokesperson Denise Bradley said Teva will pay Immunoneering…

    Published on 8/3/2015
  • COMPANY NEWS: Celgene seeks dismissal of Bass IPR petitions

    Celgene Corp. (NASDAQ:CELG) filed four motions this week with the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office requesting sanctions to dismiss inter partes review (IPR) petitions submitted by …

    Published on 7/31/2015
  • COMPANY NEWS: Management tracks

    Cancer play Unum Therapeutics Inc. (Cambridge, Mass.) named Geoffrey Hodge SVP of operations. Hodge was bioprocess technology leader at GE Healthcare Life Sciences.

    Published on 7/31/2015
  • COMPANY NEWS: Vivus to cut Qsymia sales force

    Vivus Inc. (NASDAQ:VVUS) lost $0.22 (13%) to $1.51 after it announced a restructuring plan that will halve from 100 to 50 its sales staff for Qsymia phentermine/topiramate. The company had eliminated another 50 Qsymia …

    Published on 7/31/2015
  • COMPANY NEWS: Alexion lifts revenue guidance on strong Soliris sales

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) raised its revenue guidance after reporting $636 million in Soliris eculizumab sales in 2Q15, which were up 24% from $512.5 million in 2Q14 and above analyst estimates of $628.…

    Published on 7/30/2015
  • COMPANY NEWS: Amgen gains on elevated guidance

    Amgen Inc. (NASDAQ:AMGN) gained $3.06 to $171.69 in early after hours trading on Thursday after raising its 2015 guidance and reporting 2Q15 earnings. The company now estimates $21.1-$21.4 billion in revenues, up from $…

    Published on 7/30/2015
  • COMPANY NEWS: Foundation Medicine sinks after cutting guidance

    Foundation Medicine Inc. (NASDAQ:FMI) lost $7 (24%) to $22.30 on Thursday after lowering its 2015 guidance as part of its 2Q15 earnings, which it reported after market close Wednesday (see BioCentury Extra, July 29). …

    Published on 7/30/2015
  • COMPANY NEWS: Tesaro licenses rolapitant China rights to Hengrui

    Tesaro Inc. (NASDAQ:TSRO) licensed exclusive Chinese rights for its lead candidate, oral rolapitant (SCH 619734), to Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276). FDA accepted an NDA for rolapitant to prevent …

    Published on 7/30/2015
  • COMPANY NEWS: Zai licenses preclinical cancer candidate from Sanofi

    Zai Laboratory Inc. (Shanghai, China) obtained an exclusive, worldwide license from Sanofi (Euronext:SAN; NYSE:SNY) to develop, manufacture and commercialize a preclinical multi-kinase inhibitor for oncology indications…

    Published on 7/30/2015
  • COMPANY NEWS: FDA accepts NDA for ZS Pharma hyperkalemia candidate

    ZS Pharma Inc. (NASDAQ:ZSPH) said FDA accepted for review an NDA for sodium zirconium cyclosilicate (ZS-9) to treat hyperkalemia. The PDUFA date is May 26, 2016.The inorganic crystal form of zirconium silicate designed …

    Published on 7/29/2015
  • COMPANY NEWS: Foundation Medicine lowers guidance

    Foundation Medicine Inc. (NASDAQ:FMI) shed $3.80 (13%) to $25.50 in early after-hours trading on Wednesday after the precision medicine company lowered its 2015 revenue guidance to $85-$95 million from $105-$115 million…

    Published on 7/29/2015
  • COMPANY NEWS: GSK discusses pipeline expectations, growing HIV sales

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) CEO Andrew Witty said on the company's 2Q15 earnings call that the company has about 40 drug candidates in its pipeline, with 20-25 that could be approved in the next five years. …

    Published on 7/29/2015
  • COMPANY NEWS: NICE issues draft guidances on HCV treatments

    The U.K.'s NICE published three draft guidances recommending Daklinza daclatasvir from Bristol-Myers Squibb Co. (NYSE:BMY), Viekirax ombitasvir/paritaprevir and Exviera dasabuvir from AbbVie Inc. (NYSE:ABBV), and …

    Published on 7/29/2015
  • COMPANY NEWS: Boehringer licenses NSCLC therapy from Hanmi

    Boehringer Ingelheim GmbH (Ingelheim, Germany) obtained exclusive, worldwide rights, excluding certain Asian territories, to lung cancer treatment HM61713 from Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940).Boehringer …

    Published on 7/28/2015
  • COMPANY NEWS: Gilead lifts guidance on HCV sales

    Gilead Sciences Inc. (NASDAQ:GILD) reported $4.9 billion in HCV sales in 2Q15, up 41% from $3.5 billion in 2Q14. Sales of Harvoni ledipasvir/sofosbuvir were $3.6 billion in 2Q15, while sales of Sovaldi sofosbuvir …

    Published on 7/28/2015
  • COMPANY NEWS: Management tracks

    Genomics play BGI (Shenzhen, China) announced the resignation of CEO Jun Wang. He will continue to serve as a director while he leads a new division focusing on artificial intelligence.Diagnostics company Laboratory …

    Published on 7/28/2015
  • COMPANY NEWS: Merck to acquire cCAM

    Merck & Co. Inc. (NYSE:MRK) will acquire cancer immunotherapy play cCAM Biotherapeutics Ltd. (Misgav, Israel) in a deal worth up to $605 million.The acquisition gives Merck lead candidate CM-24, a humanized IgG4 mAb …

    Published on 7/28/2015
  • COMPANY NEWS: Aegerion CEO Beer, COO Fraser resign

    Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) CEO and director Marc Beer and COO Craig Fraser resigned. Board member Sandford Smith will be interim CEO and will assume Fraser's responsibilities. The rare disease company …

    Published on 7/27/2015
  • COMPANY NEWS: Boehringer terminates Vitae BACE deal

    Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) dropped $0.70 to $9.68 after it said Boehringer Ingelheim GmbH (Ingelheim, Germany) will terminate for "strategic business reasons" a 2009 licensing deal for Vitae's beta-…

    Published on 7/27/2015

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