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  • TOP STORY: Cellectis, Pfizer in CAR T deal

    Cellectis S.A. (Euronext:ALCLS) jumped EUR 4.74 (76%) to EUR 10.94 on Wednesday after the company and Pfizer Inc. (NYSE:PFE) partnered to develop cancer immunotherapies using Cellectis' chimeric antigen receptor (CAR) T…

    Published on 6/18/2014
  • TOP STORY: FDA says tweets must include risk info

    FDA issued draft guidance requiring sponsors to include risk information when communicating about drugs on Twitter and other internet or social media platforms with character space limitations, including online paid …

    Published on 6/17/2014
  • TOP STORY: bluebird gains on beta thalassemia data

    bluebird bio Inc. (NASDAQ:BLUE) jumped $8.37 (32%) to $34.46 on Monday after reporting that two patients with beta thalassemia major who received autologous hematopoietic stem cell transplantations (HSCTs) with bluebird…

    Published on 6/16/2014
  • TOP STORY: OncoMed falls on trial halts

    OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) fell as much as $6.15 (25%) on Friday before closing the day off $2.19 to $22.71 after halting enrollment and dosing in Phase Ib trials evaluating the company's two Wnt pathway…

    Published on 6/13/2014
  • TOP STORY: FDA panel discusses CV outcomes trials in OIC

    The majority of panelists on FDA's Anesthetic and Analgesic Drug Products Advisory Committee felt cardiovascular outcomes trials weren't warranted for peripheral mu opioid receptor (OPRM1; MOR) antagonists to treat …

    Published on 6/12/2014
  • TOP STORY: NB32 may need second CV outcomes trial

    Orexigen Therapeutics Inc. (NASDAQ:OREX) fell $1 (15%) to $5.81 on Wednesday after the company made comments during a conference call that suggest FDA may require a separate study postapproval to evaluate cardiovascular…

    Published on 6/11/2014
  • TOP STORY: Achillion up after FDA lifts sovaprevir hold

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) jumped $3.54 (83%) to $7.79 on Tuesday after disclosing that FDA lifted a partial clinical hold on HCV compound sovaprevir. The company can now evaluate sovaprevir at a …

    Published on 6/10/2014
  • TOP STORY: Merck to acquire Idenix for $3.9B

    Merck & Co. Inc. (NYSE:MRK) will acquire HCV company Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) for $24.50 per share in cash, or about $3.9 billion. The price is a 239% premium to Idenix's close of $7.23 on June 6, the …

    Published on 6/9/2014
  • TOP STORY: FDA approves Biogen Idec's Eloctate

    FDA approved a BLA for Eloctate (rFVIIIFc) from Biogen Idec Inc. (NASDAQ:BIIB) to control and prevent bleeding episodes, for perioperative management and for routine prophylaxis in adults and children with hemophilia A.…

    Published on 6/6/2014
  • TOP STORY: Neuralstem to offer experimental therapy outside trial

    Neuralstem Inc. (NYSE-M:CUR) plans to take advantage of Colorado's right-to-try law to offer patients access to an experimental, unapproved human neural stem cell (hNSC) therapy (NSI-566) to treat amyotrophic lateral …

    Published on 6/5/2014
  • TOP STORY: Affiris claims disease modification with Alzheimer's placebo

    Affiris AG (Vienna, Austria) said the placebo in its Phase II trial of its AD02 vaccine against beta amyloid "is the first drug ever to demonstrate clinical and biomarker effects consistent with disease modification in …

    Published on 6/4/2014
  • TOP STORY: Teva to acquire migraine play Labrys

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) will acquire Labrys Biologics Inc. (San Mateo, Calif.) for $200 million in cash up front plus up to $625 million in developmental milestones. Labrys' sole compound is LBR-…

    Published on 6/3/2014
  • TOP STORY: More data for Merck's pembrolizumab

    Merck & Co. Inc. (NYSE:MRK) presented data at the American Society of Clinical Oncology meeting from two open-label Phase Ib trials of the pharma's pembrolizumab (MK-3475), a humanized IgG4 mAb against PD-1 receptor (…

    Published on 6/2/2014
  • TOP STORY: NCHC launches campaign to promote dialogue on drug pricing

    The National Coalition on Health Care launched a campaign aimed at increasing public discussion of high-priced drugs. The coalition -- which is comprised of labor unions, medical societies, insurance companies, and …

    Published on 5/30/2014
  • TOP STORY: BMJ says EMA backtracking on transparency

    In an editorial, the British Medical Journal said EMA's new transparency policy would make clinical trial data available in a "view on screen only" mode, which the journal said backtracks on the agency's principle of …

    Published on 5/29/2014
  • TOP STORY: WellPoint pilots cancer quality program

    WellPoint Inc. (NYSE:WLP) announced its new Cancer Care Quality Program that will reward oncologists for following recommended treatment regimens. The program will initially focus on breast, lung and colorectal cancers …

    Published on 5/28/2014
  • TOP STORY: BioCryst reports HAE data, plans $100M follow-on

    BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) rose $0.98 (11%) to $9.99 Tuesday after reporting preliminary Phase IIa data showing BCX4161 reduced frequency of angioedema attacks in a crossover trial in patients with …

    Published on 5/27/2014
  • TOP STORY: PTC jumps on CHMP reversal for ataluren

    PTC Therapeutics Inc. (NASDAQ:PTCT) jumped as much as $7.94 (52%) on Friday before closing the day up $4.71 (31%) to $20.03 after EMA's CHMP recommended conditional approval of Translarna ataluren to treat nonsense …

    Published on 5/23/2014
  • TOP STORY: Santhera leaps on detailed DMD data

    Santhera Pharmaceuticals Holding AG (SIX:SANN) jumped CHF13.94 (163%) to CHF22.50 on Thursday after presenting additional data from the Phase III DELOS trial of the company's Catena idebenone to treat Duchenne muscular …

    Published on 5/22/2014
  • TOP STORY: Chimerix raises $103.8 million in follow-on

    Chimerix Inc. (NASDAQ:CMRX) raised $103.8 million through the sale of 7.3 million shares at $14.22 in a bumped-up follow-on underwritten by Morgan Stanley; JPMorgan; Cowen; William Blair; and Canaccord. Chimerix …

    Published on 5/21/2014
  • TOP STORY: House, Senate release FDA FY15 funding bills

    The U.S. House of Representatives Appropriations Committee and U.S. Senate Appropriations Committee released respective FY15 appropriations bills for agriculture, rural development and FDA that would set FDA's base …

    Published on 5/20/2014
  • TOP STORY: Ophthotech jumps on Novartis deal

    Ophthotech Corp. (NASDAQ:OPHT) jumped $7.54 (24%) to $39 in early after-hours trading after granting Novartis AG (NYSE:NVS; SIX:NOVN) exclusive, ex-U.S. rights to develop and commercialize Fovista, which is in Phase III…

    Published on 5/19/2014
  • TOP STORY: EC approves J&J's Olysio

    The European Commission approved Olysio simeprevir from Johnson & Johnson (NYSE:JNJ) to treat HCV genotypes 1 and 4 infection in combination with peginterferon, ribavirin and/or Sovaldi sofosbuvir from Gilead Sciences …

    Published on 5/16/2014
  • TOP STORY: BMS slides on nivolumab data

    Bristol-Myers Squibb Co. (NYSE:BMY) slid $3.19 to $48.93 on Thursday after reporting results for nivolumab (BMS-936558), a human IgG4 mAb against PD-1 receptor (PDCD1; PD-1; CD279), in abstracts for the American Society…

    Published on 5/15/2014
  • TOP STORY: BMS, Celldex to study nivolumab, CDX-1127

    Celldex Therapeutics Inc. (NASDAQ:CLDX) jumped $3.34 (27%) to $15.74 on Wednesday after announcing an exclusive deal with Bristol-Myers Squibb Co. (NYSE:BMY) to evaluate combinations of anti-PD-1 receptor (PDCD1; PD-1; …

    Published on 5/14/2014

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