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  • COMPANY NEWS: IQWiG assesses DPP-4 inhibitors

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) issued preliminary benefit assessments for a group of dipeptidyl peptidase-4 (DPP-4) inhibitors that were launched before drug pricing law AMNOG came …

    Published on 7/1/2013
  • COMPANY NEWS: IQWiG backs Perjeta for some breast cancer patients

    Germany's Institute for Quality and Efficiency in Healthcare said Perjeta pertuzumab from Roche (SIX:ROG; OTCQX:RHHBY) has a "major" additional benefit in combination with the pharma's Herceptin trastuzumab and …

    Published on 7/1/2013
  • COMPANY NEWS: IQWiG rebuffs BindRen

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that BindRen colestilan from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508) is worse than sevelamer …

    Published on 7/1/2013
  • COMPANY NEWS: CHMP backs Raptor's Procysbi

    EMA's CHMP recommended approval of Procysbi cysteamine bitartrate from Raptor Pharmaceutical Corp. (NASDAQ:RPTP) to treat nephropathic cystinosis. Raptor launched Procysbi in the U.S. earlier this month with an annual …

    Published on 6/28/2013
  • COMPANY NEWS: CHMP backs Stivarga, Provenge

    EMA's CHMP backed a number of cancer compounds on Friday, including Stivarga regorafenib from Bayer AG (Xetra:BAYN) and Provenge sipuleucel-T from Dendreon Corp. (NASDAQ:DNDN). Stivarga is recommended to treat …

    Published on 6/28/2013
  • COMPANY NEWS: EMA committee backs subcutaneous Herceptin

    Roche (SIX:ROG; OTCQX:RHHBY) said EMA's CHMP backed approval of a subcutaneous formulation of Herceptin trastuzumab for HER2-positive breast cancer. The recommendation sent shares of Halozyme Therapeutics Inc. (NASDAQ:…

    Published on 6/28/2013
  • COMPANY NEWS: FDA approves non-hormonal menopause product

    FDA approved an NDA for Brisdelle paroxetine from the Noven Pharmaceuticals Inc. subsidiary of Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530; Osaka:4530) to treat moderate to severe vasomotor symptoms (VMS) -- hot …

    Published on 6/28/2013
  • COMPANY NEWS: Japan approves Lyxumia, Perjeta, subcutaneous Orencia

    Japan's Ministry of Health, Labor and Welfare (MHLW) approved several products on Friday, including Lyxumia lixisenatide from Sanofi (Euronext:SAN; NYSE:SNY) for use in combination with basal insulin to treat Type II …

    Published on 6/28/2013
  • COMPANY NEWS: Kyowa seeking Japanese approval of pegfilgrastim

    Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for pegfilgrastim (KRN125) to treat chemotherapy-induced febrile neutropenia. Kyowa has …

    Published on 6/28/2013
  • COMPANY NEWS: Perreault takes helm at CSL

    Hematology and infectious disease company CSL Ltd. (ASX:CSL) said Paul Perreault will become CEO and managing director, effective July 1. Perreault, who is president of the company's CSL Behring subsidiary, succeeds …

    Published on 6/28/2013
  • COMPANY NEWS: Sanofi gets CHMP nod for Aubagio NAS designation

    EMA's CHMP said it now recommends that Aubagio teriflunomide from Sanofi (Euronext:SAN; NYSE:SNY), which is under review to treat relapsing-remitting multiple sclerosis (RRMS), be considered a new active substance (NAS…

    Published on 6/28/2013
  • COMPANY NEWS: FDA approves Baxter's hemophilia B product

    FDA approved a BLA for Rixubis (BAX 326) from Baxter International Inc. (NYSE:BAX) to treat hemophilia B in patients 16 years of age or older. The recombinant Factor IX (rFIX) protein is approved to control and prevent …

    Published on 6/27/2013
  • COMPANY NEWS: J&J announces deals, launches Boston center

    Johnson & Johnson (NYSE:JNJ) announced a pair of deals on Thursday, alongside the launch of its Johnson & Johnson Boston Innovation Center. J&J partnered with the Icahn School of Medicine at Mount Sinai Hospital (New …

    Published on 6/27/2013
  • COMPANY NEWS: Sprout resubmits NDA for flibanserin for hypoactive sexual desire disorder

    Sprout Pharmaceuticals Inc. (Raleigh, N.C.) said it resubmitted an NDA to FDA earlier this year for flibanserin to treat hypoactive sexual desire disorder (HSDD). The company, which expects a decision on the application…

    Published on 6/27/2013
  • COMPANY NEWS: FDA committee to discuss Bayer's riociguat

    FDA's Cardiovascular and Renal Drugs Advisory Committee will meet on Aug. 6 to discuss an NDA from Bayer AG (Xetra:BAYN) for Adempas riociguat to treat pulmonary arterial hypertension (PAH) and chronic thromboembolic …

    Published on 6/26/2013
  • COMPANY NEWS: PeptiDream slides on end of Pfizer deal

    Shares of PeptiDream Inc. (Tokyo:4587) slid Y3,000 (28%) to Y7,740 on Wednesday after the company announced that it and Pfizer Inc. (NYSE:PFE) mutually terminated a 2010 deal to discover macrocyclic peptides to link to …

    Published on 6/26/2013
  • COMPANY NEWS: QRxPharma expects delay for MoxDuo review

    QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) said it expects FDA to delay an upcoming advisory committee meeting and PDUFA date for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The company said it …

    Published on 6/26/2013
  • COMPANY NEWS: Roche, AstraZeneca launch consortium

    Roche (SIX:ROG; OTCQX:RHHBY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) launched a consortium to share data related to optimizing drug design. The pharmas will contribute databases of compound properties from experiments …

    Published on 6/26/2013
  • COMPANY NEWS: BARDA awards Basilea up to $89M for BAL30072

    HHS's Biomedical Advanced Research and Development Agency (BARDA) awarded Basilea Pharmaceutica AG (SIX:BSLN) up to $89 million to develop BAL30072. The siderophore sulfactam antibiotic is in Phase I testing for severe …

    Published on 6/25/2013
  • COMPANY NEWS: EC approves Avanir's Nuedexta

    Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) said the European Commission approved an MAA for Nuedexta dextromethorphan/quinidine to treat pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.…

    Published on 6/25/2013
  • COMPANY NEWS: Eisai pulling Fycompa in Germany

    Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) said it will "temporarily" suspend commercial distribution of epilepsy drug Fycompa perampanel in Germany. The move comes after Germany's Federal Joint Committee (G-BA) issued a …

    Published on 6/25/2013
  • COMPANY NEWS: EnteroMedics submits PMA for obesity therapy to FDA

    EnteroMedics Inc. (NASDAQ:ETRM) submitted a PMA to FDA for its Maestro Rechargeable (RC) System, which delivers VBLOC vagal blocking therapy to treat obesity. The system comprises the laparoscopic implantation of two …

    Published on 6/25/2013
  • COMPANY NEWS: Seattle, Bayer in ADC deal

    Seattle Genetics Inc. (NASDAQ:SGEN) granted the Bayer Healthcare LLC subsidiary of Bayer AG (Xetra:BAYN) worldwide rights to use Seattle's auristatin-based antibody-drug conjugate (ADC) technology with undisclosed …

    Published on 6/25/2013
  • COMPANY NEWS: EC approves Xtandi

    Astellas Pharma Inc. (Tokyo:4503) and partner Medivation Inc. (NASDAQ:MDVN) said the European Commission approved an MAA for Xtandi enzalutamide to treat metastatic castration-resistant prostate cancer (CRPC) in men …

    Published on 6/24/2013
  • COMPANY NEWS: SCOTUS declines Momenta case

    The U.S. Supreme Court declined to hear an appeal from Momenta Pharmaceuticals Inc. (NASDAQ:MNTA), rebuffing the company's attempt to stop sales of a competing generic version of anticoagulant enoxaparin. Momenta's …

    Published on 6/24/2013

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