;
Skip to main content
Home > The Daily Extra > Company News

Chronological Index of : Company News

 Current Issue
  • COMPANY NEWS: Baxter's Rixubis gets CHMP nod for hemophilia B

    EMA's CHMP recommended marketing authorization of Rixubis (BAX 326) from Baxter International Inc. (NYSE:BAX) to treat and prevent bleeding in patients with hemophilia B. Approval will include a pharmacovigilance plan.…

    Published on 10/24/2014
  • COMPANY NEWS: CHMP recommends Clinuvel's Scenesse

    EMA's CHMP recommended marketing authorization under exceptional circumstances for Scenesse afamelanotide from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat phototoxicity in patients with erythropoietic …

    Published on 10/24/2014
  • COMPANY NEWS: CHMP wants more warnings for Ariad's Iclusig

    EMA's CHMP recommended stronger warnings concerning risks of blood clots and arterial blockage with use of leukemia drug Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA). CHMP's opinion endorses a similar…

    Published on 10/24/2014
  • COMPANY NEWS: Unlike FDA panel, CHMP backs AZ's olaparib

    EMA's CHMP recommended marketing authorization of Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) as maintenance treatment of platinum-sensitive relapsed ovarian, fallopian tube or peritoneal cancer in …

    Published on 10/24/2014
  • COMPANY NEWS: Venture Tracks

    PureTech Ventures (Boston, Mass.) named Robert Horvitz, Joi Ito and Raju Kucherlapati as senior partners. Horvitz, a Nobel Laureate, is a professor at Massachusetts Institute of Technology and a co-founder of Epizyme …

    Published on 10/24/2014
  • COMPANY NEWS: Celgene takes option in Sutro cancer deal

    Celgene Corp. (NASDAQ:CELG) paid Sutro Biopharma Inc. (South San Francisco, Calif.) $95 million up front in a deal to develop cancer immunotherapies using Sutro's cell-free protein synthesis technology. Celgene also …

    Published on 10/23/2014
  • COMPANY NEWS: FDA pushes back Natpara PDUFA

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP) said FDA has delayed the PDUFA date for Natpara from Oct. 24 to Jan. 24, 2015, to review a major amendment to the BLA. NPS said the agency has also asked for a REMS and will likely…

    Published on 10/23/2014
  • COMPANY NEWS: J&J to launch Texas incubator

    Johnson & Johnson (NYSE:JNJ) announced plans to open the fourth incubator in its J-Labs network, formerly known as Janssen Labs, within the new Innovation Institute at Texas Medical Center in Houston. J-Labs @ TMC, a 30…

    Published on 10/23/2014
  • COMPANY NEWS: Bavarian Nordic gains on J&J Ebola deal

    Bavarian Nordic A/S (CSE:BAVA) gained DKK36.50 (24%) to DKK186.50 after the Crucell Holland B.V. unit of Johnson & Johnson (NYSE:JNJ) paid $25 million up front to license exclusive, worldwide rights to Ebola vaccine MVA…

    Published on 10/22/2014
  • COMPANY NEWS: Biogen falls on Tecfidera miss

    Biogen Idec Inc. (NASDAQ:BIIB) fell $17.70 (5%) to $309.07 on Wednesday after reporting that Tecfidera dimethyl fumarate revenues were $787 million in 3Q14, short of the $800 million consensus estimate.U.S. sales were $…

    Published on 10/22/2014
  • COMPANY NEWS: GSK mulling ViiV IPO

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it is considering an IPO for ViiV Healthcare Ltd., the HIV joint venture it formed with Pfizer Inc. (NYSE:PFE) in 2009. On GSK's third quarter earnings call, CEO Andrew Witty…

    Published on 10/22/2014
  • COMPANY NEWS: NICE draft recommends Xarelto in ACS patients

    The U.K.'s NICE issued draft guidance recommending use of Xarelto rivaroxaban from Bayer AG (Xetra:BAYN) in combination with aspirin plus clopidogrel or aspirin alone to prevent blood clots in patients who have acute …

    Published on 10/22/2014
  • COMPANY NEWS: WuXi licenses Foundation's cancer genomics test

    Foundation Medicine Inc. (NASDAQ:FMI) has licensed the laboratory component of its FoundationOne genomic profiling test for solid tumors to WuXi PharmaTech Inc. (NYSE:WX). Oncologists use the laboratory-developed test …

    Published on 10/22/2014
  • COMPANY NEWS: Enanta falls on revised AbbVie deal

    Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) fell $4.76 (10%) to $41.83 on Tuesday after the company said it decided not to exercise its option to co-develop HCV candidate ABT-493 with AbbVie Inc. (NYSE:ABBV) in the U.S. …

    Published on 10/21/2014
  • COMPANY NEWS: FDA approves expanded Xiaflex label

    FDA approved an sBLA from Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) for Xiaflex collagenase clostridium to treat up to two Dupuytren's contracture joints in the same hand during a single treatment visit. The …

    Published on 10/21/2014
  • COMPANY NEWS: FDA panel backs Kalydeco for R117H CF patients

    FDA's Pulmonary-Allergy Drugs Advisory Committee voted 13-2 that data support approval of Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to treat cystic fibrosis patients six and older with an R117H …

    Published on 10/21/2014
  • COMPANY NEWS: NICE backs GSK's Tafinlar for melanoma

    NICE issued final guidance recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat unresectable metastatic melanoma with a BRAF V600 mutation, its approved indication. The committee …

    Published on 10/21/2014
  • COMPANY NEWS: AbbVie, Shire abandon the altar

    AbbVie Inc. (NYSE:ABBV) and Shire plc (LSE:SHP; NASDAQ:SHPG) on Monday agreed to terminate their proposed acquisition, less than a week after the pharma said it was reconsidering the deal. AbbVie must now pay Shire a $…

    Published on 10/20/2014
  • COMPANY NEWS: FDA panel backs Novartis' secukinumab for psoriasis

    FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 to recommend approval of Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) to treat moderate to severe plaque psoriasis in adults who are …

    Published on 10/20/2014
  • COMPANY NEWS: Taiho put on Fast Track in mCRC

    The Taiho Oncology Inc. subsidiary of Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) said FDA has granted Fast Track designation for its TAS-102 to treat refractory metastatic colorectal cancer (mCRC) and that the …

    Published on 10/20/2014
  • COMPANY NEWS: Astellas, CoMentis end AD collaboration

    Astellas Pharma Inc. (Tokyo:4503) and CoMentis Inc. (South San Francisco, Calif.) terminated a 2008 deal to develop and commercialize beta-secretase (BACE1) inhibitors to treat Alzheimer's disease (AD). Astellas, which…

    Published on 10/17/2014
  • COMPANY NEWS: EC approves Imbruvica for CLL, MCL

    The European Commission has approved Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and the Janssen-Cilag International NV unit of Johnson & Johnson (NYSE:JNJ) to treat patients with mantle cell lymphoma (…

    Published on 10/17/2014
  • COMPANY NEWS: FDA approves abuse-deterrent labeling for Embeda

    FDA approved expanded labeling for Embeda morphine sulfate/naltrexone hydrochloride extended-release capsules from Pfizer Inc. (NYSE:PFE) to include data from abuse-deterrent studies. Embeda is indicated to treat …

    Published on 10/17/2014
  • COMPANY NEWS: FDA reviewers: some R117H CF patients get Kalydeco benefit

    FDA reviewers said "at least some CF patients with a R117H mutation" in the cystic fibrosis transmembrane conductance regulator (CFTR) gene benefit from Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:…

    Published on 10/17/2014
  • COMPANY NEWS: NICE now recommends adjuvant Glivec

    The U.K.'s NICE proposed to recommend Glivec imatinib from Novartis AG (NYSE:NVS; SIX:NOVN) as adjuvant treatment for up to three years in adult patients at high-risk for tumor recurrence following complete surgical …

    Published on 10/17/2014

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993