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  • COMPANY NEWS: Management tracks

    Molecular diagnostics company Epigenomics AG (Xetra:ECX) named Gregory Hamilton CEO. He replaces CEO and CFO Thomas Taapken, who has left the company. Hamilton was CEO at AltheaDx Inc. (San Diego, Calif.). The company …

    Published on 6/30/2016
  • COMPANY NEWS: Esperion hammered after regulatory setback

    Esperion Therapeutics Inc. (NASDAQ:ESPR) sank $6.52 (40%) to $9.66 on Wednesday after it said FDA "did not provide clarity on a regulatory pathway" in dialogue with the company about an LDL-C lowering indication for …

    Published on 6/29/2016
  • COMPANY NEWS: Merck, Moderna in personalized cancer vaccine deal

    Moderna Therapeutics Inc. (Cambridge, Mass.) and Merck & Co. Inc.(NYSE:MRK) partnered to develop and commercialize mRNA-based cancer vaccines that encode patient-specific neoantigens. Merck will pay Moderna $200 million…

    Published on 6/29/2016
  • COMPANY NEWS: AbbVie ends deal for Infinity's duvelisib

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) said AbbVie Inc. (NYSE:ABBV) ended the companies' 2014 deal to co-develop oncology candidate duvelisib (IPI-145), and returned its rights to Infinity.Earlier this month, …

    Published on 6/28/2016
  • COMPANY NEWS: FDA panel narrowly favors CV efficacy claim for Jardiance

    On Tuesday, FDA's Endocrinology and Metabolic Drug Advisory Committee voted 12-11 that data from the EMPA-REG OUTCOME cardiovascular outcomes trial (CVOT) show diabetes drug Jardiance empagliflozin show "substantial …

    Published on 6/28/2016
  • COMPANY NEWS: Harvard Pilgrim, Lilly partner on Trulicity outcomes

    Under a deal with regional payer Harvard Pilgrim Health Care Inc. (Boston, Mass.), the reimbursement and rebate amount for diabetes drug Trulicity dulaglutide from Eli Lilly and Co. (NYSE:LLY) will hinge on how well the…

    Published on 6/28/2016
  • COMPANY NEWS: Pfizer investing $350M in Chinese center

    Pfizer Inc. (NYSE:PFE) is investing about $350 million to build the Pfizer Global Biotechnology Center in Hangzhou, China. The center, Pfizer's first in Asia, will focus on local production of biosimilars. Pfizer …

    Published on 6/28/2016
  • COMPANY NEWS: Priority Review for Roche's MS candidate

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted and granted Priority Review to a BLA for Ocrevus ocrelizumab to treat the relapsing and primary progressive forms of multiple sclerosis. Its …

    Published on 6/28/2016
  • COMPANY NEWS: Regulus shares fall after clinical hold news

    Regulus Therapeutics Inc. (NASDAQ:RGLS) plummeted $2.47 (49%) to $2.54 on Tuesday after announcing late Monday that FDA placed a full clinical hold on HCV candidate RG-101. Regulus has now reported two cases of jaundice…

    Published on 6/28/2016
  • COMPANY NEWS: Xencor jumps after bispecific antibody deal with Novartis

    Xencor Inc. (NASDAQ:XNCR) gained $4.02 (32%) to $16.56 on Tuesday after granting Novartis AG (NYSE:NVS; SIX:NOVN) rights to develop bispecific antibodies using Xencor's technology, including ex-U.S. rights to two immuno…

    Published on 6/28/2016
  • COMPANY NEWS: Priority Review for Advanced Accelerator's Lutathera

    Advanced Accelerator Applications S. A. (NASDAQ:AAAP) said FDA accepted and granted Priority Review to an NDA for Lutathera (177Lu-DOTA0-Tyr3-octreotate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETS).…

    Published on 6/27/2016
  • COMPANY NEWS: Puma submits neratinib MAA

    Puma Biotechnology Inc. (NYSE:PBYI) submitted an MAA to EMA for oral neratinib (PB272) as an extended adjuvant treatment for HER2-positive early stage breast cancer previously treated with Herceptin trastuzumab from the…

    Published on 6/27/2016
  • COMPANY NEWS: Sanofi, Boehringer swapping assets

    Sanofi (Euronext:SAN; NYSE:SNY) is to exchange its Merial animal health unit for the consumer healthcare business of Boehringer Ingelheim GmbH (Ingelheim, Germany) in an asset swap. The deal excludes Boehringer's …

    Published on 6/27/2016
  • COMPANY NEWS: Zizhu gets China rights to Uni-Bio's eye drug

    Uni-Bio Science Group Ltd. (HKSE:690) said it granted exclusive commercialization rights in China to ophthalmology treatment GeneSoft to the China Resources Zizhu Pharmaceutical Co. Ltd. subsidiary of China Resource …

    Published on 6/27/2016
  • COMPANY NEWS: CHMP recommendations include Keytruda for NSCLC

    EMA's CHMP recommended approval of PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) for non-small cell lung cancer, as well as asthma treatment Cinqaero reslizumab from Teva Pharmaceutical …

    Published on 6/24/2016
  • COMPANY NEWS: Reviewers scrutinize Jardiance's CV efficacy data

    FDA is asking an advisory committee to vote on whether data from a cardiovascular outcomes trial (CVOT) show diabetes drug Jardiance empagliflozin does not result in an unacceptable increase in CV risk, and that the …

    Published on 6/24/2016
  • COMPANY NEWS: Takeda ends Japan deal for two Amgen candidates

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said it returned its Japanese rights to fulranumab (AMG 403) and trebananib (AMG 386) to Amgen Inc. (NASDAQ:AMGN). In April, Johnson & Johnson (NYSE:JNJ) said it discontinued …

    Published on 6/24/2016
  • COMPANY NEWS: CDC panel snubs AZ's FluMist

    CDC's Advisory Committee on Immunization Practices (ACIP) recommended against use of FluMist from AstraZeneca plc (LSE:AZN; NYSE:AZN) to prevent seasonal influenza during the 2016-17 flu season. The intranasal live …

    Published on 6/23/2016
  • COMPANY NEWS: Management tracks

    Not-for-profit research organization Sage Bionetworks (Seattle, Wash.) said Stephen Friend has stepped down as president to accept a health-related position at Apple Inc. (NASDAQ:AAPL). Friend became Sage's chairman, …

    Published on 6/23/2016
  • COMPANY NEWS: Cancer research consortium gets $50M from Celgene

    Celgene Corp. (NASDAQ:CELG) will provide $50 million for access to research conducted by a newly created consortium of four academic cancer centers as part of a 10-year research collaboration.The not-for-profit The …

    Published on 6/22/2016
  • COMPANY NEWS: Management tracks

    Endocyte Inc. (NASDAQ:ECYT) said Ron Ellis resigned as president and CEO. The cancer company promoted CFO and COO Mike Sherman to succeed Ellis. Sherman will remain CFO.Bristol-Myers Squibb Co. (NYSE:BMY) promoted Murdo…

    Published on 6/22/2016
  • COMPANY NEWS: EMA reviewing Santhera's Raxone for DMD

    Santhera Pharmaceuticals Holding AG (SIX:SANN) said EMA accepted for review an MAA for the company's Raxone idebenone to treat Duchenne muscular dystrophy in patients in whom respiratory function has started to decline …

    Published on 6/21/2016
  • COMPANY NEWS: FDA approves Opko's Rayaldee

    FDA approved an NDA from Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK) for Rayaldee calcifediol to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. …

    Published on 6/21/2016
  • COMPANY NEWS: Priority Review for Nicox's eye drop

    Nicox S.A. (Euronext:COX) said FDA accepted and granted Priority Review to an NDA for AC-170, the company's topical formulation of cetirizine, to treat ocular itching associated with allergic conjunctivitis. Its PDUFA …

    Published on 6/21/2016
  • COMPANY NEWS: Eisai launches dementia registry

    Eisai Co. Ltd. (Tokyo:4523) launched its Forget Me Not digital registry, a pilot study that will collect data from patients with dementia and mild cognitive impairment. Eisai Corporate Officer Rami Suzuki told …

    Published on 6/20/2016

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