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  • TOP STORY: MorphoSys reports 1Q15 earnings

    MorphoSys AG (Xetra:MOR; Pink:MPSYF) reported 1Q15 revenues of EUR 70.4 million ($78.5 million), up from 1Q14 revenues of EUR 15.9 million ($17.7 million). The gains were largely due to the receipt of deferred revenues …

    Published on 5/5/2015
  • TOP STORY: Spark falls on UPenn's transient results in LCA

    Spark Therapeutics Inc. (NASDAQ:ONCE) slipped $3.51 to $55.01 on Monday after two studies in the New England Journal of Medicine showed that treatment effects of gene therapies declined over time in patients with Leber …

    Published on 5/4/2015
  • TOP STORY: Gilead climbs on 1Q15 earnings

    Gilead Sciences Inc. (NASDAQ:GILD) gained $4.52 to $105.03 on Friday, adding $6.7 billion in market cap to $156 billion as investors reacted to the company's 1Q15 earnings, released after market close on Thursday.The …

    Published on 5/1/2015
  • TOP STORY: House holds 21st Century Cures hearing

    U.S. House Energy & Commerce Committee members expressed bipartisan support for the second discussion draft of 21st Century Cures legislation at a hearing Thursday. Committee members outlined topics they intend to add …

    Published on 4/30/2015
  • TOP STORY: Second draft of 21st Century Cures released

    The U.S. House Energy & Commerce Committee released on Wednesday a slimmed-down discussion draft of its 21st Century Cures legislation with support from Republicans and Democrats, including Reps. Frank Pallone (D-N.J.) …

    Published on 4/29/2015
  • TOP STORY: FDA's biosimilars guidances leave questions begging

    FDA released three final guidance documents on biosimilars on Monday, but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for…

    Published on 4/28/2015
  • TOP STORY: Celladon gene therapy fails in heart failure study

    One of the quarter's most eagerly anticipated data events came up short, as Celladon Corp. (NASDAQ:CLDN) plummeted $11.04 (81%) to $2.64 on Monday after its Mydicar gene therapy missed the primary and secondary …

    Published on 4/27/2015
  • TOP STORY: Biogen falls on Tecfidera miss

    Biogen Inc. (NASDAQ:BIIB) shed $28.57 to $401.71 on Friday, losing $6.7 billion of market cap, as investors digested disappointing sales of Tecfidera dimethyl fumarate. The multiple sclerosis (MS) drug posted 1Q15 …

    Published on 4/24/2015
  • TOP STORY: Germinating arguments on CRISPR

    Meeting both expectations and concerns in the scientific community that the gene-editing technique CRISPR/Cas9 (CRISPR-associated protein 9) would be applied to human embryos, a group of Chinese researchers has …

    Published on 4/23/2015
  • TOP STORY: Ultragenyx gains on De Vivo results

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) gained $2.74 Wednesday to $66.96 after announcing positive results from an investigator-sponsored Phase II study in six evaluable patients with glucose transporter type-1 …

    Published on 4/22/2015
  • TOP STORY: Amgen boosts revenue guidance ahead of Repatha

    Amgen Inc. (NASDAQ:AMGN) boosted its revenue guidance for 2015 as it prepares to launch products in its new cardiovascular business and anticipates regulatory actions in its cancer franchise. EVP of R&D Sean Harper said…

    Published on 4/21/2015
  • TOP STORY: CAR T stocks fall on solid tumor data

    CAR T data from Novartis AG (NYSE:NVS; SIX:NOVN) and the University of Pennsylvania demonstrated much of what's already known about the challenges of moving the technology into the solid tumor setting. A presentation at…

    Published on 4/20/2015
  • 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

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