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Chronological Index of : Company News

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  • COMPANY NEWS: EC approves Gilead's Zydelig

    The European Commission approved Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic lymphocytic leukemia (CLL) and refractory follicular lymphoma (FL).Gilead declined to disclose specific plans …

    Published on 9/19/2014
  • COMPANY NEWS: GSK pledges further China investment after fine

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has pledged to "regain the trust of the Chinese people" by making further commitments and investment in China in the wake of executive convictions and a corporate fine for bribery…

    Published on 9/19/2014
  • COMPANY NEWS: Management tracks

    Aisling Capital (New York, N.Y.) promoted Aftab Kherani and Stacey Seltzer to partners from principals. They joined Aisling in 2008.Frazier Healthcare (Seattle, Wash.) hired David Socks as a venture partner. Socks will …

    Published on 9/19/2014
  • COMPANY NEWS: Whelan resigns as Ariad director

    Oncology company Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) said in an SEC filing late Thursday that Robert Whelan resigned as director, effective Oct. 1. Whelan had served on Ariad's board since April 2010.Ariad said …

    Published on 9/19/2014
  • COMPANY NEWS: Bayer to focus on life sciences, spinning out material science unit

    Bayer AG (Xetra:BAYN) said it will focus on its life science businesses and spin out its material sciences division into a separate publicly listed company in the next 12-18 months. The pharma said the major reason for …

    Published on 9/18/2014
  • COMPANY NEWS: Boehringer licenses CureVac's CV9202

    Boehringer Ingelheim GmbH (Ingelheim, Germany) licensed exclusive, worldwide rights to develop and commercialize CV9202 from CureVac GmbH (Tuebingen, Germany). The candidate is in a Phase Ib trial to treat metastatic …

    Published on 9/18/2014
  • COMPANY NEWS: EC approves Novo's combo for Type II

    The European Commission approved Xultophy (IDegLira) from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) to improve glycemic control in adults with Type II diabetes. The approval is for use in combination with oral glucose-…

    Published on 9/18/2014
  • COMPANY NEWS: FDA approves Trulicity for Type II diabetes

    FDA approved a BLA for Trulicity dulaglutide from Eli Lilly and Co. (NYSE:LLY) to improve glycemic control in Type II diabetes patients, in conjunction with diet and exercise.The once-weekly subcutaneous GLP-1 receptor …

    Published on 9/18/2014
  • COMPANY NEWS: FDA panel rebuffs Clarus' testosterone

    FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted against approval of Rextoro oral testosterone from Clarus Therapeutics Inc. (Northbrook, Ill.). The committees …

    Published on 9/18/2014
  • COMPANY NEWS: Flexion discusses sterility issue

    Flexion Therapeutics Inc. (NASDAQ:FLXN) revealed that sterility issues prompted FDA to place a clinical hold on FX006, which is in Phase IIb development for osteoarthritis knee pain.On a conference call with investors, …

    Published on 9/18/2014
  • COMPANY NEWS: Merck re-ups on biosimilars

    Merck KGaA (Xetra:MRK) said it would invest EUR 130-EUR 150 million ($168.2-$194.1 million) in biosimilars during 2015, depending on the outcome of ongoing Phase I studies. The investment comes on top of a EUR 100 …

    Published on 9/18/2014
  • COMPANY NEWS: Quicker label for Stendra boosts Vivus

    Vivus Inc. (NASDAQ:VVUS) gained $0.48 (12%) to $4.36 on Thursday after FDA approved an sNDA to amend the label of erectile dysfunction (ED) drug Stendra avanafil to indicate an earlier onset of action. The label now …

    Published on 9/18/2014
  • COMPANY NEWS: Auxilium jumps on Endo bid

    Auxilium jumped $9.66 (45%) to $31.18 on Wednesday after Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire the specialty pharma postmarket on Tuesday (see BioCentury Extra, Sept. 16).…

    Published on 9/17/2014
  • COMPANY NEWS: CVS reports on Sovaldi discontinuation rates

    Discontinuation rates for HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) were nearly four times higher in a real-world setting than in clinical trials, according to an analysis of 1,965 patients …

    Published on 9/17/2014
  • COMPANY NEWS: NICE backs Tafinlar

    The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat adults with unresectable or metastatic melanoma with a BRAF V600 …

    Published on 9/17/2014
  • COMPANY NEWS: NICE draft recommends Olysio for some HCV patients

    The U.K.'s NICE issued draft guidance recommending Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ) in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infection.…

    Published on 9/17/2014
  • COMPANY NEWS: Sanofi, MyoKardia in cardiomyopathy deal

    Sanofi (Euronext:SAN; NYSE:SNY) and MyoKardia Inc. (San Francisco, Calif.) partnered to develop targeted therapeutics for hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM).MyoKardia will develop two HCM…

    Published on 9/17/2014
  • COMPANY NEWS: Sun licenses Merck's tildrakizumab

    Merck & Co. Inc. (NYSE:MRK) granted Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) exclusive, worldwide rights to tildrakizumab (MK-3222). The anti-IL-23 antibody is in two Phase III trials to treat …

    Published on 9/17/2014
  • COMPANY NEWS: Sutro, Merck KGaA in ADC deal

    Sutro Biopharma Inc. (South San Francisco, Calif.) and the EMD Serono division of Merck KGaA (Xetra:MRK) partnered to use Sutro's Xpress CF and Xpress CF+ cell-free protein synthesis technologies to discover and develop…

    Published on 9/17/2014
  • COMPANY NEWS: Endo bids $2.2B for Auxilium

    Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire fellow specialty pharma Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) for $28.10 per share in cash and stock, or about $2.2 billion. The …

    Published on 9/16/2014
  • COMPANY NEWS: FDA approves AZ's Movantik for OIC

    FDA approved an NDA for once-daily Movantik naloxegol from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. AZ plans to launch the pegylated form of …

    Published on 9/16/2014
  • COMPANY NEWS: FDA panel to discuss Daiichi Sankyo's Savaysa

    FDA's Cardiovascular and Renal Drugs advisory committee will meet on Oct. 30 to discuss an NDA from Daiichi Sankyo Co. Ltd. (Tokyo:4568) for Savaysa edoxaban to prevent stroke and systemic embolic events in patients …

    Published on 9/16/2014
  • COMPANY NEWS: Jenkins joins Dimension as CEO

    Dimension Therapeutics (Cambridge, Mass.) hired Annalisa Jenkins as CEO. She previously was EVP and head of global R&D at the Merck Serono S.A. biopharmaceutical division of Merck KGaA (Xetra:MRK). Jenkins succeeds …

    Published on 9/16/2014
  • COMPANY NEWS: Lilly buys into AZ's BACE for Alzheimer's

    Eli Lilly and Co. (NYSE:LLY) will pay up to $500 million to AstraZeneca plc (LSE:AZN; NYSE:AZN) under a deal for the pharmas to jointly develop and commercialize AZ's AZD3293 for Alzheimer's disease.The partners said …

    Published on 9/16/2014
  • COMPANY NEWS: Merck Serono, Lupin in emerging markets deal

    The Merck Serono S.A. biopharmaceutical division of Merck KGaA (Xetra:MRK) partnered with Lupin Ltd. (NSE:LUPIN; BSE:500257) to develop and commercialize up to 20 general medicines in emerging markets. Lupin will …

    Published on 9/16/2014

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