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  • COMPANY NEWS: Celltrion grants Remsima marketing rights to Mundipharma

    Celltrion Inc. (KOSDAQ:068270) subsidiary Celltrion Healthcare Hungary Kft granted Mundipharma International Ltd. (Cambridge, U.K.) exclusive distribution rights to market Remsima infliximab in the U.K., Germany, Italy,…

    Published on 8/14/2014
  • COMPANY NEWS: Coherus reports PK data for Humira biosimilar

    Coherus BioSciences Inc. (Redwood City, Calif.) said CHS-1420, its biosimilar of Humira adalimumab, met the primary endpoint of pharmacokinetic similarity to Humira. PK endpoints measured maximum serum concentration, …

    Published on 8/14/2014
  • COMPANY NEWS: FDA committee backs Boehringer's Spiriva Respimat

    FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-3 that existing data support approval of Spiriva Respimat from Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat chronic obstructive pulmonary disease (…

    Published on 8/14/2014
  • COMPANY NEWS: Priority Review for Pfizer's meningitis B vaccine

    FDA accepted and granted Priority Review to a BLA from Pfizer Inc. (NYSE:PFE) for recombinant LP2086 (rLP2086) to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in people 10-25 years…

    Published on 8/14/2014
  • COMPANY NEWS: 23andMe, Pfizer to study IBD genetics

    23andMe Inc. (Mountain View, Calif.) partnered with Pfizer Inc. (NYSE:PFE) to explore the genetic factors associated with the onset, progression, severity and response to inflammatory bowel disease (IBD). Under the deal…

    Published on 8/13/2014
  • COMPANY NEWS: CDC backs routine use of Prevnar 13 in adults over 65

    The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommended routine use of pneumococcal vaccine Prevnar/Prevenar 13 from Pfizer Inc. (NYSE:PFE) for adults 65 …

    Published on 8/13/2014
  • COMPANY NEWS: FDA reviewers highlight mixed safety for Spiriva Respimat

    An FDA reviewer said mortality data for Spiriva Respimat tiotropium from Boehringer Ingelheim GmbH (Ingelheim, Germany) are "not entirely consistent," between the Phase III TIOSPIR trial and a pooled analysis of placebo…

    Published on 8/13/2014
  • COMPANY NEWS: InterMune gains on rumored bids

    InterMune Inc. (NASDAQ:ITMN) rose $6.57 (14%) to $52.06 on Wednesday after media reports surfaced that at least four companies made bids to acquire the company and that InterMune has hired Goldman Sachs and Centerview …

    Published on 8/13/2014
  • COMPANY NEWS: Sanofi licenses preclinical compounds to China's Zai Lab

    Sanofi (Euronext:SAN; NYSE:SNY) granted newco Zai Laboratory Inc. (Shanghai, China) a worldwide license to develop, manufacture and commercialize two preclinical compounds to treat chronic respiratory diseases, …

    Published on 8/12/2014
  • COMPANY NEWS: Vertex discontinuing Incivek

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) will discontinue sales of HCV drug Incivek telaprevir in the U.S. by Oct. 16 in light of available alternative treatments and diminishing market demand, according to a letter …

    Published on 8/12/2014
  • COMPANY NEWS: Celgene, Human Longevity in stem cell deal

    Celgene Cellular Therapeutics, a subsidiary of Celgene Corp. (NASDAQ:CELG), granted Human Longevity Inc. (San Diego, Calif.) rights to develop and co-market PSC-100, a placental stem cell population. Celgene will make …

    Published on 8/11/2014
  • COMPANY NEWS: Cologuard gets green light from FDA, CMS

    FDA approved Cologuard from Exact Sciences Corp. (NASDAQ:EXAS) as a non-invasive DNA screening test for colorectal cancer. Separately, CMS issued a proposed National Coverage Determination (NCD) for Cologuard, the first…

    Published on 8/11/2014
  • COMPANY NEWS: EC approves Eylea for DME

    The European Commission approved Eylea aflibercept from Bayer AG (Xetra:BAYN) for treating visual impairment due to diabetic macular edema (DME). Bayer has ex-U.S. rights to the drug from Regeneron Pharmaceuticals Inc.…

    Published on 8/11/2014
  • COMPANY NEWS: FAAH Pharma debuts with deal, financing

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) granted newco FAAH Pharma Inc. (Montreal, Quebec) exclusive, worldwide rights to IPI-940, an oral fatty acid amide hydrolase (FAAH) inhibitor. In 2015, FAAH Pharma plans to …

    Published on 8/11/2014
  • COMPANY NEWS: MannKind licenses Afrezza to Sanofi

    MannKind Corp. (NASDAQ:MNKD) granted Sanofi (Euronext:SAN; NYSE:SNY) exclusive, worldwide rights to develop and commercialize Afrezza inhaled insulin to treat adults with Type I and II diabetes. MannKind will receive $…

    Published on 8/11/2014
  • COMPANY NEWS: Medivir names Prager CEO

    Infectious disease company Medivir AB (SSE:MVIR B) hired Niklas Prager to succeed Maris Hartmanis as president and CEO, effective Sept. 1. Prager previously was chairman of BioPhausia, which Medivir acquired in 2011. He…

    Published on 8/11/2014
  • COMPANY NEWS: CRUK, Astellas partner to discover pancreatic cancer targets

    Cancer Research UK (London, U.K.) and its Cancer Research Technology Ltd. commercial arm partnered with Astellas Pharma Inc. (Tokyo:4503) to identify and validate targets to block the autophagy pathway in pancreatic …

    Published on 8/8/2014
  • COMPANY NEWS: DiNonA licences leukotuximab to 3SBio

    DiNonA Inc. (Seoul, South Korea) granted 3SBio Inc. (Shenyang, China) exclusive rights to develop and commercialize DiNonA's leukotuximab in Taiwan and China, including Hong Kong and Macau, as well as the Middle East, …

    Published on 8/8/2014
  • COMPANY NEWS: Genentech submits sBLA for Lucentis for diabetic retinopathy

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) submitted an sBLA to FDA to expand the label for Lucentis ranibizumab to include diabetic retinopathy. The humanized mAb fragment against VEGF-A is approved in the…

    Published on 8/8/2014
  • COMPANY NEWS: NICE rebuffs Kadcyla as too expensive

    The U.K.'s NICE issued a final appraisal determination recommending against Kadcyla trastuzumab emtansine from Roche (SIX:ROG; OTCQX:RHHBY) to treat HER2-positive, unresectable, locally advanced or metastatic breast …

    Published on 8/8/2014
  • COMPANY NEWS: Charleston Labs, Daiichi Sankyo in co-development deal

    Charleston Laboratories Inc. (Jupiter, Fla.) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) partnered to develop and commercialize Charleston's fixed-dose combination hydrocodone products to treat pain and opioid-induced …

    Published on 8/7/2014
  • COMPANY NEWS: Durata falls on news of CMS NTAP denial

    Durata Therapeutics Inc. (NASDAQ:DRTX) fell $1.93 (12%) to $13.65 on Thursday after an analyst published a note highlighting CMS's denial of a new technology add on payment (NTAP) for Dalvance dalbavancin, which the …

    Published on 8/7/2014
  • COMPANY NEWS: Emergent submits BLA for anthrax treatment

    Biodefense company Emergent BioSolutions Inc. (NYSE:EBS) submitted a BLA to FDA for Anthrax immune globulin IV (AIGIV) to treat inhaled anthrax. Emergent gained rights to the product -- a solution of human polyclonal …

    Published on 8/7/2014
  • COMPANY NEWS: Gilead to provide Sovaldi in India for about $900

    Gilead Sciences Inc. (NASDAQ:GILD) said it expects to provide HCV drug Sovaldi sofosbuvir in India at about $300 for a four-week supply -- or $900 for a 12-week course of therapy, which the company said is its standard …

    Published on 8/7/2014
  • COMPANY NEWS: Hirawat resigns as PTC president

    Claudia Hirawat is resigning as president of PTC Therapeutics Inc. (NASDAQ:PTCT). In a letter to staff, Hirawat said she would continue to consult for the company but has no immediate plans for the future and a timeline…

    Published on 8/7/2014

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