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  • TOP STORY: G-BA suspends Glybera assessment pending EMA decision

    The German reimbursement agency G-BA suspended its benefit assessment of gene therapy Glybera alipogene tiparvovec from uniQure N.V. (NASDAQ:QURE). The move followed uniQure's disclosure in an SEC filing that on April 8…

    Published on 4/17/2015
  • TOP STORY: FDA approves first generic Copaxone

    FDA approved once-daily Glatopa glatiramer acetate from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) to treat relapsing forms of multiple sclerosis (MS). Glatopa is …

    Published on 4/16/2015
  • TOP STORY: Aduro's market cap surges to $2.5B after upsized IPO

    Aduro Biotech Inc. (NASDAQ:ADRO) gained $25 (147%) to $42 in its first day of trading Wednesday after raising $144 million in an IPO and concurrent private placement.Aduro raised $119 million in its upsized IPO through …

    Published on 4/15/2015
  • TOP STORY: Galapagos' filgotinib meets Phase II endpoint in RA

    Galapagos N.V. (Euronext:GLPG; Pink:GLPYY) said Janus kinase-1 (JAK-1) inhibitor filgotinib (GLPG0634) met the primary endpoint vs. placebo of the Phase IIb DARWIN 1 trial to treat rheumatoid arthritis (RA). Galapagos …

    Published on 4/14/2015
  • TOP STORY: FDA reviewers back narrowed cangrelor indication

    In briefing documents released ahead of Wednesday's meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, reviewers recommended approval of Kengreal cangrelor from The Medicines Co. (NASDAQ:MDCO) as an …

    Published on 4/13/2015
  • TOP STORY: FDA committee to discuss CV risks of DPP-4s

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on April 14 to discuss results from two CV outcomes trials of dipeptidyl peptidase-4 (DPP-4) inhibitors marketed by AstraZeneca plc (LSE:AZN; NYSE:…

    Published on 4/10/2015
  • TOP STORY: Priority Review erases Shire's losses on trial miss

    Shire plc (LSE:SHP; NASDAQ:SHPG) turned early losses on clinical data into gains on Thursday, picking up $7.24 to $254.32 on NASDAQ after FDA accepted for filing and granted Priority Review to an NDA for lifitegrast (…

    Published on 4/9/2015
  • TOP STORY: Enanta gains on Phase II HCV data

    Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) gained $3.71 (11%) to $36.38 on Wednesday after partner AbbVie Inc. (NYSE:ABBV) reported preliminary data from a Phase IIb trial of a once-daily oral combo of the biotech's ABT-…

    Published on 4/8/2015
  • TOP STORY: OrbiMed leads $35M round for True North

    True North Therapeutics Inc. (South San Francisco, Calif.) raised $35 million in an untranched series B round led by new investor OrbiMed. Existing investors Kleiner Perkins Caufield & Byers; MPM Capital; SR One; and …

    Published on 4/7/2015
  • TOP STORY: BMS teams with uniQure for CV gene therapies

    In less than a year, uniQure N.V. (NASDAQ:QURE) has parlayed its EUR 3 million ($4 million) acquisition of InoCard GmbH into an expansive deal with Bristol-Myers Squibb Co. (NYSE:BMY). News of the deal sent uniQure's …

    Published on 4/6/2015
  • TOP STORY: SanBio rides regenerative medicine wave in Japan

    SanBio Co. Ltd. (Tokyo:4592) raised Y8 billion ($67.2 million) through the sale of 4 million shares at Y2,000 in an IPO, with the shares set to begin trading April 8 on the Tokyo Stock Exchange's Mothers. The price …

    Published on 4/3/2015
  • TOP STORY: Japan launches AMED to foster innovation

    The Japanese government launched the Agency for Medical Research and Development on April 1. The agency, a Japanese counterpart to NIH, is intended to foster medical innovation and drug development in the country.AMED …

    Published on 4/2/2015
  • TOP STORY: Sarepta CEO resigns ahead of FDA meeting

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) gained $1.01 to $14.29 on Wednesday on news that Christopher Garabedian resigned as president, CEO and director after a Tuesday meeting with the board. CMO Edward Kaye will become…

    Published on 4/1/2015
  • TOP STORY: CMS outlines biosimilar reimbursement

    In biosimilar reimbursement documents issued Tuesday, CMS removed an incentive for physicians to prescribe more expensive Medicare Part B innovator drugs and opened the door to formulary exclusions of innovator drugs …

    Published on 3/31/2015
  • TOP STORY: Teva acquiring CNS play Auspex for $3.5B

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is buying neurology play Auspex Pharmaceuticals Inc. (NASDAQ:ASPX) for $101 per share, or $3.5 billion in cash. The price is a 42% premium to Auspex's Friday close of $70.…

    Published on 3/30/2015
  • TOP STORY: BioMarin rises on takeout rumors

    Rare disease company BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) jumped $13.23 (11%) to $128.78 on Friday, ending the day with a market cap of $20.5 billion, amid rumors that Shire plc (LSE:SHP; NASDAQ:SHPG) has …

    Published on 3/27/2015
  • TOP STORY: Biotech stocks steady after Wednesday's slide

    Biotech stocks traded relatively flat Thursday, recovering from moderate losses in intraday trading. The sector posted sharp declines earlier in the week as some investors feared that biotechs have become overvalued …

    Published on 3/26/2015
  • TOP STORY: Biotech stocks pummeled on bubble fears

    Biotech stocks took a beating Wednesday on fears that companies in the sector have become overvalued after an extended updraft. The Wall Street Journal published a story highlighting investor anxiety over the bull run, …

    Published on 3/25/2015
  • TOP STORY: Keytruda tops Yervoy in first-line melanoma

    Merck & Co. Inc. (NYSE:MRK) said an interim analysis of a Phase III trial showed Keytruda pembrolizumab was superior to Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY) on the co-primary endpoints of …

    Published on 3/24/2015
  • TOP STORY: Lawmakers introduce permanent Priority Review voucher bill

    Five U.S. Representatives introduced the Advancing Hope Act of 2015, a bill that would reauthorize and make permanent the Priority Review voucher incentive program for rare pediatric diseases. The bill's sponsors …

    Published on 3/23/2015
  • TOP STORY: Biogen climbs on early Alzheimer's data

    Biogen Idec Inc. (NASDAQ:BIIB) gained $42.33 (10%) to $475.98 on Friday after reporting detailed Phase Ib data for Alzheimer's disease (AD) candidate aducanumab (BIIB037).Aducanumab led to statistically significant …

    Published on 3/20/2015
  • TOP STORY: Researchers call for gene editing caution

    Advances in the use of the gene editing technology CRISPR for germline modifications have prompted a group of academic researchers and bioethicists to call for a conference of stakeholders to manage public concerns and …

    Published on 3/19/2015
  • TOP STORY: Stakeholders aiming to renew pediatric voucher program

    FDA issued its third Priority Review voucher under its pediatric disease voucher program Tuesday, which triggers a 12-month clock until the pilot program ends. The program is intended to give pharma companies incentives…

    Published on 3/18/2015
  • TOP STORY: Nektar misses in breast cancer

    Nektar Therapeutics (NASDAQ:NKTR) said etirinotecan pegol (NKTR-102) missed the primary endpoint of an improvement in median overall survival in the Phase III BEACON trial in metastatic breast cancer. Patients treated …

    Published on 3/17/2015
  • TOP STORY: PCSK9 inhibitors continue neck-and-neck

    In newly published analyses, the PCSK9 inhibitors Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) and Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) showed …

    Published on 3/16/2015

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