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Chronological Index of : Company News

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  • COMPANY NEWS: J&J, U of Toronto in neuroscience deal

    The Janssen Biotech Inc. subsidiary of Johnson & Johnson (NYSE:JNJ) partnered with the University of Toronto's Center for Collaborative Drug Research (CCDR) to develop therapies to treat mood disorders and Alzheimer's …

    Published on 9/8/2014
  • COMPANY NEWS: NICE rebuffs Abraxane for pancreatic cancer

    The U.K.'s NICE issued draft guidance recommending against the use of Abraxane nab-paclitaxel from Celgene Corp. (NASDAQ:CELG) for first-line treatment of metastatic pancreatic cancer in combination with gemcitabine -- …

    Published on 9/8/2014
  • COMPANY NEWS: Scandal craters Hyperion's DiaPep277

    Hyperion Therapeutics Inc. (NASDAQ:HPTX) said it is terminating diabetes candidate DiaPep277 following research misconduct -- a move that comes just three months after Hyperion spent about $20.4 million to acquire …

    Published on 9/8/2014
  • COMPANY NEWS: Tesaro submits NDA for oral rolapitant

    Tesaro Inc. (NASDAQ:TSRO) submitted an NDA to FDA for oral rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV). The company has exclusive, worldwide rights to the neurokinin 1 (NK1) Substance P …

    Published on 9/8/2014
  • COMPANY NEWS: FDA accepts ceftazidime/avibactam NDA

    Actavis plc (NYSE:ACT) said FDA accepted for review an NDA for ceftazidime/avibactam (CAZ-104) to treat complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs). The PDUFA date is …

    Published on 9/5/2014
  • COMPANY NEWS: FDA approves Keryx's ferric citrate

    FDA approved ferric citrate from Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) to treat hyperphosphatemia in dialysis-dependent patients with chronic kidney disease (CKD). FDA contraindicated the drug in patients with …

    Published on 9/5/2014
  • COMPANY NEWS: FDA reviewers question nebivolol/valsartan benefit

    FDA reviewers questioned whether a fixed-dose combination of nebivolol and valsartan from Actavis plc (NYSE:ACT) provides a "clinically meaningful" benefit in patients with hypertension. The reviewers noted the combo …

    Published on 9/5/2014
  • COMPANY NEWS: Lilly funding challenge of CMS's amyloid coverage

    Eli Lilly and Co. (NYSE:LLY) is helping to finance a lawsuit seeking to overturn a 2013 decision from CMS to only cover beta amyloid imaging in Medicare patients with dementia or neurodegenerative diseases only if the …

    Published on 9/5/2014
  • COMPANY NEWS: Biocartis raises EUR 64.5M, spins out newco

    Biocartis S.A. (Lausanne, Switzerland) raised EUR 64.5 million ($84.7 million) in an undisclosed venture round and separately spun out a newco, MyCartis, to develop the multiplex assay technology of Biocartis' Evalution…

    Published on 9/4/2014
  • COMPANY NEWS: Levinson resigns as Roche director

    Roche (SIX:ROG; OTCQX:RHHBY) said Arthur Levinson resigned as a director, effective immediately, to avoid conflicts of interest with his role as CEO of Calico LLC (San Francisco, Calif.). Calico was launched by Google …

    Published on 9/4/2014
  • COMPANY NEWS: Calico, AbbVie in age-related disease R&D deal

    AbbVie Inc. (NYSE:ABBV) and Calico LLC (San Francisco, Calif.) will provide up to $1.5 billion to discover, develop and commercialize treatments for age-related diseases, including neurodegeneration and cancer. The …

    Published on 9/3/2014
  • COMPANY NEWS: Infinity leaps on AbbVie deal

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) jumped $4.82 (44%) to $15.74 on Wednesday after it partnered with AbbVie Inc. (NYSE:ABBV) to develop and commercialize duvelisib (IPI-145), an oral inhibitor of …

    Published on 9/3/2014
  • COMPANY NEWS: Alder falls after BMS returns clazakizumab rights

    Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) fell $2.24 (13%) to $14.80 on Tuesday after Bristol-Myers Squibb Co. (NYSE:BMY) discontinued development of clazakizumab (BMS-945429) and returned worldwide rights to Alder. …

    Published on 9/2/2014
  • COMPANY NEWS: Amgen submits evolocumab MAA

    Amgen Inc. (NASDAQ:AMGN) submitted an MAA to EMA for evolocumab (AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9), to treat high cholesterol. The application -- the first in the EU for…

    Published on 9/2/2014
  • COMPANY NEWS: Amgen submits talimogene MAA

    Amgen Inc. (NASDAQ:AMGN) submitted an MAA to EMA for talimogene laherparepvec to treat regionally and distantly metastatic melanoma. In July, Amgen disclosed that it submitted a BLA to FDA for the modified herpes …

    Published on 9/2/2014
  • COMPANY NEWS: Epizyme's Rhodes resigns as president, CFO

    Cancer epigenetics company Epizyme Inc. (NASDAQ:EPZM) said Jason Rhodes resigned as president and CFO, effective Sept. 30. The company said Rhodes is joining an undisclosed VC fund. Prior to joining Epizyme in 2010, …

    Published on 9/2/2014
  • COMPANY NEWS: HHS awards $24.9M to Mapp

    HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded Mapp Biopharmaceutical Inc. (San Diego, Calif.) a $24.9 million, 18-month contract for development and manufacturing of the company's …

    Published on 9/2/2014
  • COMPANY NEWS: Novo Nordisk discontinues inflammation R&D

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) is discontinuing all inflammatory disease R&D. Novo ended development of its lead compound in the space, NN8226, which is a recombinant human mAb neutralizing IL-20 in Phase II …

    Published on 9/2/2014
  • COMPANY NEWS: Priority Review for Actavis' eluxadoline

    FDA accepted and granted Priority Review to an NDA from Actavis plc (NYSE:ACT) for eluxadoline (JNJ-270189066) to treat diarrhea and abdominal pain in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).…

    Published on 9/2/2014
  • COMPANY NEWS: Roche had multiple competitors in InterMune acquisition

    InterMune Inc. (NASDAQ:ITMN) revealed in an SEC filing that multiple other companies expressed interest in a deal before Roche (SIX:ROG; OTCQX:RHHBY) agreed to acquire InterMune for $74 per share, or $8.3 billion in …

    Published on 9/2/2014
  • COMPANY NEWS: UTHR soars on patent win

    United Therapeutics Corp. (NASDAQ:UTHR) gained $26.14 (29%) to $117.83 on Friday after the U.S. District Court for the District of New Jersey ruled that Sandoz's ANDA for generic intravenous treprostinil will infringe …

    Published on 8/29/2014
  • COMPANY NEWS: China approves BTG's DC Bead

    BTG plc (LSE:BTG) and SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) said the China Food and Drug Administration (CFDA) approved BTG's DC Bead to treat patients with malignant hypervascularized tumors like hepatocellular …

    Published on 8/28/2014
  • COMPANY NEWS: Luye buys majority stake in Beijing Jialin

    Luye Pharma Group Ltd. (HKSE:2186) will acquire a 58% stake in Beijing Jialin Pharmaceutical Co. Ltd. from Beijing Jialin shareholders Mylin Holding Group Co. Ltd. (Beijing, China) and Beijing CITIC in a tranched RMB3.7…

    Published on 8/28/2014
  • COMPANY NEWS: NICE requests Jardiance cost effectiveness data

    The U.K.'s NICE issued draft guidance concerning the cost effectiveness of Type II diabetes drug Jardiance empagliflozin (BI-10773) from partners Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (…

    Published on 8/28/2014
  • COMPANY NEWS: Roche, Chugai amend licensing deal

    Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said it and majority owner Roche (SIX:ROG; OTCQX:RHHBY) amended an agreement covering the geographic regions and timing of Roche's first refusal rights to Chugai compounds. …

    Published on 8/28/2014

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