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  • COMPANY NEWS: BMS beats Street, posts ex-U.S. HCV sales

    Bristol-Myers Squibb Co. (NYSE:BMY) reported total revenues of $4.2 billion in 2Q15, including $479 million from ex-U.S. sales of HCV drugs Daklinza daclatasvir and Sunvepra asunaprevir. The overall sales beat the …

    Published on 7/23/2015
  • COMPANY NEWS: Genentech moves crenezumab into Phase III for AD

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said it will begin Phase III testing in 2016 of crenezumab to treat patients with prodromal to mild Alzheimer's disease, triggering an undisclosed milestone …

    Published on 7/23/2015
  • COMPANY NEWS: Ablynx, Merck extend Nanobodies deal

    Ablynx N.V. (Euronext:ABLX) and Merck & Co. Inc. (NYSE:MRK) extended a deal to discover and develop Nanobodies targeting undisclosed immune checkpoint modulators for cancer. The deal will be extended for four years and …

    Published on 7/22/2015
  • COMPANY NEWS: EC approves Merck's Keytruda to treat melanoma

    Merck & Co. Inc. (NYSE:MRK) said the EC approved an MAA for Keytruda pembrolizumab for first-line and previously treated patients with unresectable or metastatic melanoma.FDA approved the humanized IgG4 mAb against PD-1…

    Published on 7/22/2015
  • COMPANY NEWS: GPhA hires PhRMA's Davis as CEO

    The Generic Pharmaceutical Association named Chester Davis president and CEO, effective Aug. 18. Davis will leave Pharmaceutical Research and Manufacturers of America, where he is EVP for advocacy and member relations.…

    Published on 7/22/2015
  • COMPANY NEWS: Management tracks

    Neurology play Denali Therapeutics Inc. (South San Francisco, Calif.) hired Carole Ho as CMO and head of development. Ho was VP of early clinical development at the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).…

    Published on 7/22/2015
  • COMPANY NEWS: Actelion raises 2015 guidance

    In its quarterly earnings announcement, Actelion Ltd. (SIX:ATLN) raised its 2015 guidance based on strong uptake of pulmonary arterial hypertension (PAH) drug Opsumit macitentan in 2Q15, slower than expected erosion in …

    Published on 7/21/2015
  • COMPANY NEWS: CAFC ruling delays Zarxio launch until Sept. 2

    The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a ruling and extended an injunction that will delay until Sept. 2 the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:…

    Published on 7/21/2015
  • COMPANY NEWS: Management tracks

    The MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) hired David Berman as SVP and head of its oncology innovative medicines unit. He will succeed Edward Bradley, who will serve in an advisory role until he …

    Published on 7/21/2015
  • COMPANY NEWS: Pfizer details new focus on maternal vaccines

    Pfizer Inc. (NYSE:PFE) said it is developing three preclinical programs as part of its maternal immunization vaccine strategy, in which it will develop vaccines administered to pregnant women that are designed to …

    Published on 7/21/2015
  • COMPANY NEWS: Prime suggests limited PCSK9 coverage

    Pharmacy benefit manager Prime Therapeutics LLC (Eagan, Minn.) suggested Tuesday it may limit access to PCSK9 inhibitors to patients with familial hypercholesterolemia based on an analysis of its claims data that showed…

    Published on 7/21/2015
  • COMPANY NEWS: EC approves nivolumab for squamous NSCLC

    Bristol-Myers Squibb Co. (NYSE:BMY) said the European Commission approved an MAA for nivolumab to treat locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy. Last month, the EC …

    Published on 7/20/2015
  • COMPANY NEWS: Management tracks

    Oncology company Sorrento Therapeutics Inc. (NASDAQ:SRNE) said EVP and chief commercial officer George Uy will step down at the end of July to become CEO of an undisclosed start-up.Rare disease play Ultragenyx …

    Published on 7/20/2015
  • COMPANY NEWS: Tekmira changing name to Arbutus with HBV focus

    Tekmira Pharmaceuticals Corp. (NASDAQ:TKMR) said it will change its name to Arbutus Biopharma Corp., effective Aug. 3, and will focus on developing HBV therapies. It will form a separate business unit for non-HBV …

    Published on 7/20/2015
  • COMPANY NEWS: Management tracks

    Cancer company Exelixis Inc. (NASDAQ:EXEL) named Chris Senner EVP and CFO. Senner was VP of corporate finance at Gilead Sciences Inc. (NASDAQ:GILD). Gene therapy company uniQure N.V. (NASDAQ:QURE) hired Charles Richard …

    Published on 7/17/2015
  • COMPANY NEWS: QIDP for Motif's iclaprim triggers L22M placing

    FDA granted Qualified Infectious Disease Product (QIDP) designation to iclaprim from Motif Bio plc (LSE:MTFB) to treat hospital-acquired bacterial pneumonia (HABP), triggering a L22 million ($34.1 million) placing. …

    Published on 7/17/2015
  • COMPANY NEWS: Aslan, NCCS to study GI cancers

    Aslan Pharmaceuticals Pte. Ltd. (Singapore) and the National Cancer Centre Singapore signed a memorandum of understanding to jointly study gastrointestinal cancers that are disproportionately prevalent in Asia.Aslan and…

    Published on 7/16/2015
  • COMPANY NEWS: Exact Sciences, hedge fund spar over Cologuard

    Exact Sciences Corp. (NASDAQ:EXAS) and hedge fund Cable Car Capital each proposed reimbursement rates for Cologuard at a CMS meeting to discuss 2016 payment levels for clinical tests. The meeting follows a campaign by …

    Published on 7/16/2015
  • COMPANY NEWS: Five Prime, Inhibrx in GITR antibody deal

    Five Prime Therapeutics Inc. (NASDAQ:FPRX) obtained exclusive, worldwide rights from Inhibrx LLC (La Jolla, Calif.) to its preclinical glucocorticoid-induced tumor necrosis factor receptor (TNFR)-related protein (GITR; …

    Published on 7/16/2015
  • COMPANY NEWS: Otsuka seeks to block Alkermes' Abilify formulation

    Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) filed a Citizen's Petition with FDA asking the agency to deny or delay approval of an NDA for aripiprazole lauroxil from Alkermes plc (NASDAQ:ALKS) to treat schizophrenia. …

    Published on 7/16/2015
  • COMPANY NEWS: Canbridge gains China rights to APG101

    Apogenix GmbH (Heidelberg, Germany) granted Canbridge Life Sciences Ltd. (Beijing, China) exclusive rights to APG101 in China, Macao and Hong Kong to treat glioblastoma multiforme (GBM), with options in additional …

    Published on 7/15/2015
  • COMPANY NEWS: Celgene, Receptos both rise after deal

    Celgene Corp. (NASDAQ:CELG) and Receptos Inc. (NASDAQ:RCPT) each posted gains on Wednesday, a day after Celgene said it will acquire Receptos for $232 per share, or $7.2 billion net of Receptos' cash (see BioCentury …

    Published on 7/15/2015
  • COMPANY NEWS: Management tracks

    Antibiotics developer Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) named Jacques Dumas CSO. He was CSO at Idenix Pharmaceuticals Inc., which Merck & Co. Inc. (NYSE:MRK) acquired.Antibacterial company Entasis …

    Published on 7/15/2015
  • COMPANY NEWS: Takeda submits NDA for ixazomib in MM

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) submitted an NDA to FDA for ixazomib to treat relapsed and/or refractory multiple myeloma. The company based its submission on the ongoing Phase III TOURMALINE-MM1 study. An …

    Published on 7/15/2015
  • COMPANY NEWS: Fate, U Minn in immunotherapy deal

    Fate Therapeutics Inc. (NASDAQ:FATE) partnered with the University of Minnesota to develop NK cell-based off-the-shelf immunotherapies for cancer. The deal combines the university's technology to produce persistent NK …

    Published on 7/14/2015

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