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  • COMPANY NEWS: FDA issues CRL for Kalydeco

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) fell $5.11 to $86.61 on Friday after FDA issued a complete response letter for an sNDA seeking to expand the label of cystic fibrosis drug Kalydeco ivacaftor to include patients…

    Published on 2/5/2016
  • COMPANY NEWS: Gilead's Mansuri joining Sanofi

    Sanofi (Euronext:SAN; NYSE:SNY) hired Muzammil Mansuri as EVP of strategy and business development, effective Feb. 22. In the role, he also will be responsible for the pharma's Sanofi-Genzyme BioVentures corporate …

    Published on 2/5/2016
  • COMPANY NEWS: SciClone seeking alternatives

    SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) gained $0.65 to $8.76 on Friday after reporting late Thursday that it settled an investigation with the SEC and hired Lazard to help the company seek strategic alternatives. …

    Published on 2/5/2016
  • COMPANY NEWS: FDA panel backs cognitive dysfunction claim for Brintellix

    FDA's Psychopharmacologic Drugs Advisory Committee voted 8-2 on Wednesday that H. Lundbeck A/S (CSE:LUN) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) provided substantial evidence to support an efficacy claim…

    Published on 2/4/2016
  • COMPANY NEWS: Tessier-Lavigne to become Stanford president

    Stanford University (Stanford, Calif.) hired Marc Tessier-Lavigne as president, effective Sept. 1. He will succeed John Hennessy, who last year announced plans to step down as president.Tessier-Lavigne has been …

    Published on 2/4/2016
  • COMPANY NEWS: Mersana, Takeda expand relationship

    Mersana Therapeutics Inc. (Cambridge, Mass.) granted Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) rights to co-develop Mersana's lead internal program, XMT-1522, a preclinical antibody-drug conjugate (ADC) targeting HER2…

    Published on 2/3/2016
  • COMPANY NEWS: Adaptimmune, GSK expand TCR deal for NY-ESO-1

    Adaptimmune Therapeutics plc (NASDAQ:ADAP) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expanded a deal under which the companies are co-developing an autologous T cell receptor (TCR) therapy targeting cancer/testis …

    Published on 2/2/2016
  • COMPANY NEWS: Gilead still eyeing cancer, inflammation deals

    Gilead Sciences Inc. (NASDAQ:GILD) reported earnings that showed a continued reliance on HCV sales and company executives expressed interest in dealmaking to broaden Gilead's cancer and inflammatory portfolios."It's …

    Published on 2/2/2016
  • COMPANY NEWS: U.K. court invalidates Regeneron mouse patents

    Kymab Ltd. (Cambridge, U.K.) said the English High Court revoked two patents from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) protecting VelocImmune mice and humanized mouse antibodies derived from the mice. Regeneron …

    Published on 2/2/2016
  • COMPANY NEWS: Abbott buys diagnostics company Alere

    Abbott Laboratories (NYSE:ABT) is acquiring diagnostics play Alere Inc. (NYSE:ALR) for $56 per share in cash, or about $5.8 billion. Abbott said it will assume or refinance Alere's net debt of $2.6 billion. The …

    Published on 2/1/2016
  • COMPANY NEWS: Avalanche acquires Annapurna

    Avalanche Biotechnologies Inc. (NASDAQ:AAVL) will acquire Annapurna Therapeutics S.A.S. (Paris, France), gaining four preclinical gene therapy programs outside of ophthalmology. Annapurna shareholders will receive 17.6 …

    Published on 2/1/2016
  • COMPANY NEWS: Huya, Eisai strike deal for Chipscreen drug

    Huya Bioscience International LLC (San Diego, Calif.) granted Eisai Co. Ltd. (Tokyo:4523) exclusive rights to HBI-8000 in several Asian territories. Huya has ex-China rights to the drug from Shenzhen Chipscreen …

    Published on 2/1/2016
  • COMPANY NEWS: Portola partners andexanet alfa in Japan

    Portola Pharmaceuticals Inc. (NASDAQ:PTLA) partnered with Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE: PFE) to develop and commercialize Portola's andexanet alfa (PRT064445) in Japan. The recombinant …

    Published on 2/1/2016
  • COMPANY NEWS: Aetna, Novartis strike deal on Entresto

    Aetna Inc. (NYSE:AET) told BioCentury on Friday that it struck an outcomes-based pricing deal with Novartis AG (NYSE:NVS; SIX:NOVN) for heart failure drug Entresto sacubitril/valsartan.Novartis agreed to an undisclosed …

    Published on 1/29/2016
  • COMPANY NEWS: Allergan, AZ partner to develop antibiotic

    Allergan plc (NYSE:AGN) said it partnered with AstraZeneca plc (LSE:AZN; NYSE:AZN) to develop ATM-AVI, a combination of antibiotics aztreonam and avibactam to treat Gram-negative infections.ATM-AVI was developed under a…

    Published on 1/29/2016
  • COMPANY NEWS: CHMP backs basket of therapies

    EMA's CHMP recommended marketing authorization of three new medicines Thursday and recommended label expansions for Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) and Revolade eltrombopag from Novartis AG (NYSE:…

    Published on 1/29/2016
  • COMPANY NEWS: FDA panel to discuss Acadia's Nuplazid for PDP

    FDA's Psychopharmacologic Drugs Advisory Committee will meet on March 29 to discuss an NDA for Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) to treat Parkinson's disease psychosis. The NDA is …

    Published on 1/29/2016
  • COMPANY NEWS: Gilead promotes Milligan to CEO

    Gilead Sciences Inc. (NASDAQ:GILD) said President and COO John Milligan will be promoted to CEO and will join Gilead's board, effective March 10. Current Chairman and CEO John Martin will become executive chairman. …

    Published on 1/29/2016
  • COMPANY NEWS: Management tracks

    The EMD Serono unit of Merck KGaA (Xetra:MRK) named Gary Zieziula president and managing director for North America. Zieziula was EMD Serono's chief commercial officer. Immuno-oncology company Surface Oncology Inc. (…

    Published on 1/29/2016
  • COMPANY NEWS: Synergy submits plecanatide NDA

    Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) said it submitted an NDA to FDA for plecanatide, a guanylate cyclase C (GCC; GUCY2C) agonist to treat chronic idiopathic constipation (CIC).Last year, plecanatide met the …

    Published on 1/29/2016
  • COMPANY NEWS: Breakthrough designation for AZ's Lynparza in CRPC

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA granted breakthrough therapy designation to Lynparza olaparib as monotherapy to treat metastatic castration-resistant prostate cancer. The designation covers CRPC patients …

    Published on 1/28/2016
  • COMPANY NEWS: FDA approves Merck's HCV combo

    FDA approved Zepatier grazoprevir/elbasvir (MK-5172/MK-8742) from Merck & Co. Inc. (NYSE:MRK) with or without ribavirin to treat HCV genotypes 1 and 4 in adults. Merck said Thursday it would launch the drug within seven…

    Published on 1/28/2016
  • COMPANY NEWS: Genentech in-licenses Amgen's AMG 282

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) received exclusive global rights from Amgen Inc. (NASDAQ:AMGN) to AMG 282, an antibody against IL-1 receptor-like 1 (IL1RL1; ST2). The antibody prevents IL-33 from…

    Published on 1/28/2016
  • COMPANY NEWS: Neos rises after ADHD approval

    Neos Therapeutics Inc. (NASDAQ:NEOS) gained $3.96 (42%) to $13.38 on Thursday after FDA approved Adzenys XR-ODT (NT-0202) to treat ADHD in patients aged six and older. Chief Commercial Officer Thomas McDonnell said Neos…

    Published on 1/28/2016
  • COMPANY NEWS: Priority Review for Exelixis' cabozantinib in RCC

    Exelixis Inc. (NASDAQ:EXEL) said FDA granted Priority Review to an NDA for a tablet formulation of cabozantinib (XL184) as second-line therapy to treat advanced renal cell carcinoma. Its PDUFA date is June 22. Exelixis …

    Published on 1/28/2016

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