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

Chronological Index of : Company News

 Current Issue
  • COMPANY NEWS: Priority Review for Advanced Accelerator's Lutathera

    Advanced Accelerator Applications S. A. (NASDAQ:AAAP) said FDA accepted and granted Priority Review to an NDA for Lutathera (177Lu-DOTA0-Tyr3-octreotate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETS).…

    Published on 6/27/2016
  • COMPANY NEWS: Puma submits neratinib MAA

    Puma Biotechnology Inc. (NYSE:PBYI) submitted an MAA to EMA for oral neratinib (PB272) as an extended adjuvant treatment for HER2-positive early stage breast cancer previously treated with Herceptin trastuzumab from the…

    Published on 6/27/2016
  • COMPANY NEWS: Sanofi, Boehringer swapping assets

    Sanofi (Euronext:SAN; NYSE:SNY) is to exchange its Merial animal health unit for the consumer healthcare business of Boehringer Ingelheim GmbH (Ingelheim, Germany) in an asset swap. The deal excludes Boehringer's …

    Published on 6/27/2016
  • COMPANY NEWS: Zizhu gets China rights to Uni-Bio's eye drug

    Uni-Bio Science Group Ltd. (HKSE:690) said it granted exclusive commercialization rights in China to ophthalmology treatment GeneSoft to the China Resources Zizhu Pharmaceutical Co. Ltd. subsidiary of China Resource …

    Published on 6/27/2016
  • COMPANY NEWS: CHMP recommendations include Keytruda for NSCLC

    EMA's CHMP recommended approval of PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) for non-small cell lung cancer, as well as asthma treatment Cinqaero reslizumab from Teva Pharmaceutical …

    Published on 6/24/2016
  • COMPANY NEWS: Reviewers scrutinize Jardiance's CV efficacy data

    FDA is asking an advisory committee to vote on whether data from a cardiovascular outcomes trial (CVOT) show diabetes drug Jardiance empagliflozin does not result in an unacceptable increase in CV risk, and that the …

    Published on 6/24/2016
  • COMPANY NEWS: Takeda ends Japan deal for two Amgen candidates

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said it returned its Japanese rights to fulranumab (AMG 403) and trebananib (AMG 386) to Amgen Inc. (NASDAQ:AMGN). In April, Johnson & Johnson (NYSE:JNJ) said it discontinued …

    Published on 6/24/2016
  • COMPANY NEWS: CDC panel snubs AZ's FluMist

    CDC's Advisory Committee on Immunization Practices (ACIP) recommended against use of FluMist from AstraZeneca plc (LSE:AZN; NYSE:AZN) to prevent seasonal influenza during the 2016-17 flu season. The intranasal live …

    Published on 6/23/2016
  • COMPANY NEWS: Management tracks

    Not-for-profit research organization Sage Bionetworks (Seattle, Wash.) said Stephen Friend has stepped down as president to accept a health-related position at Apple Inc. (NASDAQ:AAPL). Friend became Sage's chairman, …

    Published on 6/23/2016
  • COMPANY NEWS: Cancer research consortium gets $50M from Celgene

    Celgene Corp. (NASDAQ:CELG) will provide $50 million for access to research conducted by a newly created consortium of four academic cancer centers as part of a 10-year research collaboration.The not-for-profit The …

    Published on 6/22/2016
  • COMPANY NEWS: Management tracks

    Endocyte Inc. (NASDAQ:ECYT) said Ron Ellis resigned as president and CEO. The cancer company promoted CFO and COO Mike Sherman to succeed Ellis. Sherman will remain CFO.Bristol-Myers Squibb Co. (NYSE:BMY) promoted Murdo…

    Published on 6/22/2016
  • COMPANY NEWS: EMA reviewing Santhera's Raxone for DMD

    Santhera Pharmaceuticals Holding AG (SIX:SANN) said EMA accepted for review an MAA for the company's Raxone idebenone to treat Duchenne muscular dystrophy in patients in whom respiratory function has started to decline …

    Published on 6/21/2016
  • COMPANY NEWS: FDA approves Opko's Rayaldee

    FDA approved an NDA from Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK) for Rayaldee calcifediol to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. …

    Published on 6/21/2016
  • COMPANY NEWS: Priority Review for Nicox's eye drop

    Nicox S.A. (Euronext:COX) said FDA accepted and granted Priority Review to an NDA for AC-170, the company's topical formulation of cetirizine, to treat ocular itching associated with allergic conjunctivitis. Its PDUFA …

    Published on 6/21/2016
  • COMPANY NEWS: Eisai launches dementia registry

    Eisai Co. Ltd. (Tokyo:4523) launched its Forget Me Not digital registry, a pilot study that will collect data from patients with dementia and mild cognitive impairment. Eisai Corporate Officer Rami Suzuki told …

    Published on 6/20/2016
  • COMPANY NEWS: Management tracks

    Immunotherapy company Hookipa Biotech AG (Vienna, Austria) named Joern Aldag CEO. He was CEO of uniQure N.V. (NASDAQ:QURE).Cancer company Aprea AB (Solna, Sweden) named Christian Schade president and CEO. He was CEO of …

    Published on 6/16/2016
  • COMPANY NEWS: Aegerion, QLT merging

    Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) and QLT Inc. (TSX:QLT; NASDAQ:QLTI) are to merge in a stock deal to create Novelion Therapeutics Inc. The combined company would have two marketed rare disease products and …

    Published on 6/15/2016
  • COMPANY NEWS: CFDA approves TaiGen antibiotic

    TaiGen Biopharmaceuticals Holdings Ltd. (TPEx:4157) said China FDA approved Taigexyn nemonoxacin, a non-fluorinated quinolone antibiotic topoisomerase inhibitor. The company said it is CFDA's first new drug approval …

    Published on 6/15/2016
  • COMPANY NEWS: USPSTF releases final CRC screening guidelines

    Final guidelines on colorectal cancer screening from the U.S. Preventive Services Task Force (USPSTF) no longer recommend specific screening tests, but instead detail the level of evidence to support the effectiveness …

    Published on 6/15/2016
  • COMPANY NEWS: Acucela slides after Otsuka ends ophthalmic deals

    Acucela Inc. (Tokyo:4589) sank Y400 (24%) to Y1,253 on Tuesday after it said Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) terminated co-development deals for Acucela's emixustat (formerly ACU-4429) and Otsuka's OPA-…

    Published on 6/14/2016
  • COMPANY NEWS: Shire licenses IBD biologic from Pfizer

    Pfizer Inc. (NYSE:PFE) granted Shire plc (LSE:SHP; NASDAQ:SHPG) global rights to inflammatory bowel disease (IBD) candidate PF-00547659. Deal terms were not disclosed. The mAb targeting mucosal vascular addressing cell …

    Published on 6/14/2016
  • COMPANY NEWS: Teva returns CV rights for Mesoblast stem cell therapy

    Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) fell A$0.81 (42%) to A$1.11 in Australia on Tuesday and $2.87 (41%) to $4.20 on NASDAQ after Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) returned rights to Mesoblast's …

    Published on 6/14/2016
  • COMPANY NEWS: FDA to discuss Amgen's Humira biosimilar

    FDA's Arthritis Advisory Committee is to meet July 12 to discuss a BLA from Amgen Inc. (NASDAQ:AMGN) for ABP 501, a proposed biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).Amgen is seeking the biosimilar's…

    Published on 6/13/2016
  • COMPANY NEWS: Eagle soars after bendamustine patent ruling

    A judge in the U.S. District Court for the District of Delaware upheld most claims of a patent from the Cephalon Inc. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) covering cancer drug Treanda …

    Published on 6/10/2016
  • COMPANY NEWS: FDA approves PaxVax's Vaxchora, grants voucher

    FDA approved a BLA for Vaxchora (PXVX0200) from PaxVax Inc. (Redwood City, Calif.) to prevent cholera caused by serogroup O1 in adults aged 18 to 64 traveling to cholera-affected areas. PaxVax received a Priority Review…

    Published on 6/10/2016

< 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