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Chronological Index of : Company News

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  • COMPANY NEWS: FDA panel backs Merck anti-infective Zinplava

    FDA's Antimicrobial Drugs Advisory Committee voted 10-5, with one abstention, that Merck & Co. Inc. (NYSE:MRK) provided substantial evidence that Zinplava bezlotoxumab is safe and effective to prevent Clostridium …

    Published on 6/9/2016
  • COMPANY NEWS: FDA to discuss Sandoz biosimilar, Valeant's brodalumab

    FDA scheduled advisory committee meetings to discuss BLAs for biosimilar etanercept (GP2015) from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and brodalumab (KHK4827) from Valeant Pharmaceuticals International …

    Published on 6/9/2016
  • COMPANY NEWS: Management tracks

    Gruenenthal Group (Aachen, Germany) named Gabriel Baertschi CEO, effective Oct. 1. He will replace Eric-Paul Paques, who will retire. Baertschi is country president for Japan at AstraZeneca plc (LSE:AZN; NYSE:AZN). CNS …

    Published on 6/9/2016
  • COMPANY NEWS: Aptose, CrystalGenomics in deal for multi-kinase inhibitor

    CrystalGenomics Inc. (KOSDAQ:083790) granted Aptose Biosciences Inc. (TSX:APS; NASDAQ:APTO) an exclusive option to license rights to CG026806 outside of China and Korea. The compound is a small molecule inhibitor of …

    Published on 6/8/2016
  • COMPANY NEWS: EpimAb, Innovent partner in bispecific antibodies

    EpimAb Biotherapeutics Inc. (Shanghai, China) granted Innovent Biologics Inc. (Suzhou, China) rights to its Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to develop bispecific antibodies against multiple targets. The …

    Published on 6/8/2016
  • COMPANY NEWS: FDA panel backs Troxyca efficacy, two abuse claims

    FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 9-6 to recommend approval of Troxyca ER oxycodone/naltrexone (ALO-02) from Pfizer Inc. (NYSE:PFE) to treat pain …

    Published on 6/8/2016
  • COMPANY NEWS: Takeda gets rights to Theravance's GI candidate

    Theravance Biopharma Inc. (NASDAQ:TBPH) granted Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) a global license to develop and commercialize serotonin (5-HT4) receptor agonist TD-8954 to treat gastrointestinal motility …

    Published on 6/8/2016
  • COMPANY NEWS: Alexion sags after Soliris' myasthenia gravis miss

    Alexion Therapeutics Inc. (NASDAQ:ALXN) sank $16.86 (11%) to $138.13 on Tuesday after post-market news Monday that Soliris eculizumab missed the primary endpoint in the Phase III REGAIN study to treat refractory …

    Published on 6/7/2016
  • COMPANY NEWS: FDA panels recommend Teva's Vantrela ER

    FDA's Anesthetic and Analgesic Drug Products committee and Drug Safety and Risk Management advisory committee voted 14-3 to recommend approval of Vantrela ER hydrocodone bitartrate (CEP-33237) from Teva Pharmaceutical …

    Published on 6/7/2016
  • COMPANY NEWS: FDA reviewers question efficacy of Merck's bezlotoxumab

    In briefing documents released ahead of an advisory committee meeting to discuss an NDA for bezlotoxumab (MK-6072) from Merck & Co. Inc. (NYSE:MRK) to prevent recurrences of Clostridium difficle infection, FDA reviewers…

    Published on 6/7/2016
  • COMPANY NEWS: Judge overturns HCV patent ruling in Merck-Gilead case

    A federal judge reversed a jury's decision in March that had upheld two HCV patents and had awarded $200 million in damages to Merck & Co. Inc. (NYSE:MRK) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) from Gilead …

    Published on 6/7/2016
  • COMPANY NEWS: Sarepta rises after FDA requests more data

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) jumped $3.62 (23%) to $19.67 on Tuesday after disclosing late Monday that FDA requested additional data from PROMOVI, the company's ongoing Phase III confirmatory trial of …

    Published on 6/7/2016
  • COMPANY NEWS: Sorrento, 3SBio in CAR T deal

    Sorrento Therapeutics Inc. (NASDAQ:SNRE) said its TNK Therapeutics Inc. subsidiary formed a JV with 3SBio Inc. (HKSE:1530) focused on chimeric antigen receptor T cell therapies. TNK will grant the JV rights in China, …

    Published on 6/7/2016
  • COMPANY NEWS: Takeda, Roivant create new home for relugolix

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Roivant Sciences Ltd. (Hamilton, Bermuda) launched Myovant Sciences Ltd., a newco which will hold exclusive ex-Asia rights to women's health and prostate cancer candidate …

    Published on 6/7/2016
  • COMPANY NEWS: Ultragenyx, Takeda in deal for rare genetic diseases

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) partnered to develop and commercialize therapies to treat rare genetic diseases. Ultragenyx will receive an exclusive license …

    Published on 6/7/2016
  • COMPANY NEWS: AstraZeneca continues to divest Zurampic rights

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said it granted Gruenenthal Group (Aachen, Germany) exclusive rights to gout drug Zurampic lesinurad in Europe and Latin America. AZ is eligible for $230 million in sales and other …

    Published on 6/2/2016
  • COMPANY NEWS: Novartis opens Shanghai research center

    Novartis AG (NYSE:NVS; SIX:NOVN) opened a new R&D campus in Shanghai. The company said the new site houses more than 1,000 people in its Novartis Institutes for BioMedical Research (NIBR), its Alcon Inc. opthalmic unit …

    Published on 6/2/2016
  • COMPANY NEWS: EMA names first therapies in PRIME scheme

    EMA has accepted four therapies into its PRIority MEdicines (PRIME) scheme, the agency's equivalent to FDA's Breakthrough Therapy designation. The four are aducanumab (BIIB037) from Biogen Inc. (NASDAQ:BIIB), CCX168 …

    Published on 6/1/2016
  • COMPANY NEWS: FDA reviewing Radius' abaloparatide

    Radius Health Inc. (NASDAQ:RDUS) said FDA accepted for review its NDA for abaloparatide-SC (BA-058-SC) to treat osteoporosis in postmenopausal women. Spokesperson Lori Gorski told BioCentury that FDA has yet to provide …

    Published on 6/1/2016
  • COMPANY NEWS: Sangamo's Lanphier to retire

    Sangamo BioSciences Inc. (NASDAQ:SGMO) said Edward Lanphier is retiring as president and CEO, a position he has held since Sangamo was founded in 1995.Sangamo named Alexander Macrae as Lanphier's replacement, effective …

    Published on 6/1/2016
  • COMPANY NEWS: BioMarin ending Kyndrisa development

    BioMarin Pharmaceuticals Inc. (NASDAQ:BMRN) said it withdrew an MAA for Duchenne muscular dystrophy (DMD) candidate Kyndrisa drisapersen after EMA's CHMP "clearly indicated" that it intended to issue a negative opinion.…

    Published on 5/31/2016
  • COMPANY NEWS: EC approves Amicus' Galafold

    The European Commission approved an MAA for Galafold migalastat from Amicus Therapeutics Inc. (NASDAQ:FOLD) to treat Fabry's disease. Amicus said the label covers 35-50% of Fabry's patients with any of 269 disease-…

    Published on 5/31/2016
  • COMPANY NEWS: FDA approves Intercept's Ocaliva for PBC

    FDA granted accelerated approval to Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) to treat primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in patients with …

    Published on 5/31/2016
  • COMPANY NEWS: Link gets China rights to 4SC cancer candidate

    4SC AG (Xetra:VSC) granted Link Health Group (Guangzhou, China) exclusive rights to oncology candidate 4SC-205 in China, Hong Kong, Taiwan and Macau. Link Health will be responsible for clinical development of the oral …

    Published on 5/31/2016
  • COMPANY NEWS: NICE spurns Imbruvica, but opens door to CDF

    In draft guidance, the U.K.'s NICE recommended against use of Imbruvica ibrutinib from Johnson & Johnson (NYSE:JNJ) and AbbVie Inc. (NYSE:ABBV) to treat chronic lymphocytic leukemia (CLL) in patients without a 17p …

    Published on 5/31/2016

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