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  • TOP STORY: Sanofi's pick checks boxes in emerging markets, established products

    Investors had a muted response to the appointment of Olivier Brandicourt as the new CEO at Sanofi (Euronext:SAN; NYSE:SNY), as the pharma's shares shed EUR 0.45 to EUR 87.39 on Euronext and were unchanged at $50.10 on …

    Published on 2/20/2015
  • TOP STORY: Sanofi names Brandicourt CEO

    Sanofi (Euronext:SAN; NYSE:SNY) named Olivier Brandicourt CEO effective April 2, choosing an outsider to replace ousted CEO Christopher Viehbacher. Brandicourt was most recently chairman of the board of management and …

    Published on 2/19/2015
  • TOP STORY: FDA to discuss oversight of next-generation sequencing

    FDA will hold a public workshop on Friday to discuss the agency's development of a regulatory framework for next-generation sequencing (NGS) tests.In a discussion draft, FDA said traditional regulatory approaches are …

    Published on 2/18/2015
  • TOP STORY: China FDA issues draft revisions to GCPs

    China FDA has issued long-awaited draft revisions to its Good Clinical Practices guidelines for pharmaceutical trials.The Chinese-language draft proposes changes to 34 GCP provisions, but should have few direct effects …

    Published on 2/17/2015
  • TOP STORY: Eisai's lenvatinib latest of FDA's quick approvals

    FDA approved Lenvima lenvatinib (E7080) from Eisai Co. Ltd. (Tokyo:4523) to treat progressive, radioiodine-refractory differentiated thyroid cancer. The approval comes well ahead of the drug's April 14 PDUFA date, …

    Published on 2/13/2015
  • TOP STORY: J&J forms groups to tackle prevention, microbiome

    Johnson & Johnson (NYSE:JNJ) announced on Thursday the creation of three new dedicated groups to concentrate its R&D work in disease interception, disease prevention and microbiome research. Each of the new groups will …

    Published on 2/12/2015
  • TOP STORY: Genzyme, Voyager in CNS gene therapy tie-up

    Voyager Therapeutics Inc. (Cambridge, Mass.) and the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) partnered to develop and commercialize Voyager's gene therapies for CNS diseases.The deal gives Genzyme options …

    Published on 2/11/2015
  • TOP STORY: Hospira, Pfenex in deal for Lucentis biosimilar

    Pfenex Inc. (NYSE-M:PFNX) jumped $1.10 (16%) to $8 on Tuesday after partnering with Hospira Inc. (NYSE:HSP) to collaborate on the development of PF-582, Pfenex's biosimilar of Lucentis ranibizumab from the Genentech Inc…

    Published on 2/10/2015
  • TOP STORY: Achillion climbs on ACH-3102 data

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) gained $0.84 to $11.66 on Monday after it said 100% of HCV genotype 1 patients receiving ACH-3102 plus Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) achieved an …

    Published on 2/9/2015
  • TOP STORY: Merck, Simcere JV fallout

    A high-profile China joint venture formed in 2011 between Simcere Pharmaceutical Group (Nanjing, China) and Merck & Co. Inc. (NYSE:MRK) appears to be coming to an end, with Simcere taking over management of SMSD (…

    Published on 2/6/2015
  • TOP STORY: Hamburg resigning, future FDA leadership unclear

    Margaret Hamburg announced her resignation Thursday as FDA commissioner. In a memo to agency staff, Hamburg said FDA Chief Scientist Stephen Ostroff will serve as acting commissioner when she steps down at the end of …

    Published on 2/5/2015
  • TOP STORY: New China FDA chief signals pricing reform a priority

    A change at the top of China FDA may indicate that drug pricing reform is now a top priority of the government.China State Council Deputy Secretary-General Bi Jingquan will serve as both CFDA commissioner and secretary-…

    Published on 2/4/2015
  • TOP STORY: Gilead provides peek at HCV discount, starts dividend program

    Gilead Sciences Inc. (NASDAQ:GILD) projected that its HCV drugs will see a U.S. blended rebate of about 46% in 2015 and announced the start of a dividend program. The announcements came as the company announced 2014 …

    Published on 2/3/2015
  • TOP STORY: Obama asks for modest FDA budget bump

    The Obama administration's FY16 budget request proposes small increases in appropriations for FDA's medical product review centers, and targets most of the new funds for efforts to combat antibiotic-resistant bacteria …

    Published on 2/2/2015
  • TOP STORY: Spark catches fire in first trading day

    Gene therapy developer Spark Therapeutics Inc. (NASDAQ:ONCE) gained $27 (117%) to $50 on Friday, its first day of trading after raising $161 million in an IPO on NASDAQ through the sale of 7 million shares at $23. The …

    Published on 1/30/2015
  • TOP STORY: Intercept's OCA gets breakthrough designation in NASH

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) gained $49.31 (29%) to $220 in after hours-trading on Thursday after it said FDA granted breakthrough therapy designation to its OCA obeticholic acid (DSP-1747) to treat non-…

    Published on 1/29/2015
  • TOP STORY: UnitedHealth picks Harvoni

    UnitedHealth Group Inc. (NYSE:UNH) said on Wednesday that it has selected Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) as its preferred regimen to treat HCV genotype 1 over Viekira Pak from …

    Published on 1/28/2015
  • TOP STORY: Democrats snub 21st Century Cures bill

    Nine months after U.S. House Energy & Commerce Committee chairman Rep. Fred Upton (R-Mich.) launched the 21st Century Cures initiative as a bipartisan effort, the committee released a discussion draft Tuesday without …

    Published on 1/27/2015
  • TOP STORY: FDA names Duke's Califf as deputy commissioner

    FDA named Robert Califf as deputy commissioner for medical products and tobacco, positioning the Duke University physician as a likely successor to Commissioner Margaret Hamburg if she steps down before the end of the …

    Published on 1/26/2015
  • TOP STORY: FDA approves NPS's Natpara with boxed warning

    FDA approved Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The recombinant human parathyroid hormone 1-84 (PTH) …

    Published on 1/23/2015
  • TOP STORY: Warren's punishing scheme to tap pharma for NIH

    Sen. Elizabeth Warren (D-Mass.) plans to introduce legislation next week that she said would force large pharmaceutical companies entering major settlements with the U.S. government to pay NIH "one percent of an …

    Published on 1/22/2015
  • TOP STORY: China's Innovent raises $100M in series C

    Innovent Biologics Inc. (Suzhou, China) raised $100 million in an untranched series C round led by new investor Legend Capital. Singapore's Temasek and two other undisclosed new investors also participated, along with …

    Published on 1/21/2015
  • TOP STORY: Volatility continues to dog CAR T stocks

    After a partial recovery last Friday, shares of companies developing chimeric antigen receptor (CAR) T cell therapies fell on Tuesday after an article in the New York Times suggested the sector may be overheated. The …

    Published on 1/20/2015
  • TOP STORY: Roche buys neuromuscular play Trophos

    Roche (SIX:ROG; OTCQX:RHHBY) acquired neuromuscular disease play Trophos S.A. (Marseille, France) for EUR 120 million ($141.8 million) in upfront cash. Trophos shareholders are eligible for up to EUR 350 million ($413.6…

    Published on 1/16/2015
  • TOP STORY: Two more payers pick Harvoni

    Humana Inc. (NYSE:HUM) and Harvard Pilgrim Health Care Inc. each said they selected Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) as the exclusive option for HCV genotype 1 patients and thus will…

    Published on 1/15/2015

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