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

Chronological Index of : Company News

 Current Issue
  • COMPANY NEWS: Clovis dropping rociletinib, focusing on rucaparib

    Clovis Oncology Inc. (NASDAQ:CLVS) said late Thursday that it expects FDA to issue a complete response letter for an NDA for rociletinib (CO-1686). The company intends to focus resources instead on its next most-…

    Published on 5/5/2016
  • COMPANY NEWS: Medivation holds firm as Sanofi raises takeout pressure

    Medivation Inc. (NASDAQ:MDVN) again rejected an acquisition offer from Sanofi (Euronext:SAN; NYSE:SNY) as CEO David Hung insisted Thursday that the company's existing business plan would create more shareholder value …

    Published on 5/5/2016
  • COMPANY NEWS: Merck's Frazier discusses deal appetite

    Merck & Co. Inc. (NYSE:MRK) President and CEO Kenneth Frazier said the pharma is actively searching for licensing or bolt-on deals, and would consider a deal larger than its $8.4 billion takeout of Cubist …

    Published on 5/5/2016
  • COMPANY NEWS: NICE now backs both Repatha and Praluent

    The U.K.'s NICE issued final appraisal determinations (FADs) recommending the use of PCSK9 inhibitors Praluent alirocumab and Repatha evolocumab. The committee backed both drugs for primary non-familial …

    Published on 5/5/2016
  • COMPANY NEWS: Panel backs KemPharm analgesic, doubts abuse deterrence

    FDA's Anesthetic and Analgesic Drug Products and Risk Management Advisory Committees voted 16-4 that the agency should approve Apadaz benzhydrocodone/acetaminophen (KP201/APAP) from KemPharm Inc. (NASDAQ:KMPH) for the …

    Published on 5/5/2016
  • COMPANY NEWS: Regeneron raises Eylea guidance

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gained $17.09 to $377.73 on Thursday after it reported earnings and raised 2016 guidance for sales of its ophthalmic drug Eylea aflibercept. The company now expects 20-25% …

    Published on 5/5/2016
  • COMPANY NEWS: Wave, Pfizer begin metabolic disease collaboration

    Wave Life Sciences Ltd. (NASDAQ:WVE) and Pfizer Inc. (NYSE:PFE) partnered to design and develop stereopure nucleic acid therapeutics for metabolic diseases. The partners will investigate therapies for five genetically …

    Published on 5/5/2016
  • COMPANY NEWS: Management tracks

    Gene therapy company uniQure N.V. (NASDAQ:QURE) named Paul Firuta chief commercial officer. He was chief commercial officer at BioBlast Pharma Ltd. (NASDAQ:ORPN).Metabolic company Orexigen Therapeutics Inc. (NASDAQ:OREX…

    Published on 5/4/2016
  • COMPANY NEWS: Priority Review for Lilly's olaratumab

    Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to a BLA for olaratumab (LY3012207) in combination with doxorubicin to treat advanced soft tissue sarcoma (STS) that cannot be treated with …

    Published on 5/4/2016
  • COMPANY NEWS: Alnylam tumbles on ALN-CC5 update

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) fell $7.98 (12%) to $60.81 on Tuesday after reporting that it will narrow its development program for paroxysmal nocturnal hemoglobinuria (PNH) therapy ALN-CC5 to target poor …

    Published on 5/3/2016
  • COMPANY NEWS: Quintiles, IMS Health merging

    CRO Quintiles Transnational Holdings Inc. (NYSE:Q) and healthcare data and IT company IMS Health Holdings Inc. (NYSE:IMS) are merging in an all-stock deal. The parties expect the deal to close next half.The companies …

    Published on 5/3/2016
  • COMPANY NEWS: Koppel to leave Biogen

    Biogen Inc. (NASDAQ:BIIB) said EVP of Strategy and Business Development Adam Koppel will leave the company on June 2. He had led the biotech's business development activities since EVP of Corporate Development Steven …

    Published on 5/2/2016
  • COMPANY NEWS: AZ cutting costs, boosting oncology investment

    In its 1Q16 earnings report Friday, AstraZeneca plc (NYSE:AZN; LSE:AZN) said it would reduce core SG&A expenses to support continued investment in oncology. AZ estimated $1.1 billion in savings from unspecified cuts, …

    Published on 4/29/2016
  • COMPANY NEWS: FDA approves Acadia's Nuplazid

    FDA approved Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) to treat hallucinations and delusions associated with psychosis in Parkinson's disease patients. It is the first approved drug in the …

    Published on 4/29/2016
  • COMPANY NEWS: Gilead sinks after HCV sales miss estimates

    Gilead Sciences Inc. (NASDAQ:GILD) lost $8.79 to $88.21 on Friday after reporting earning that missed analyst estimates, in part due to lower than expected revenue from HCV drug Harvoni ledipasvir/sofosbuvir. The …

    Published on 4/29/2016
  • COMPANY NEWS: New drugs backed by CHMP include Zavicefta, Zinbryta

    On Friday, EMA's CHMP recommended approval of several new drugs, including Zavicefta ceftazidime/avibactam (CAZ-104), Zinbryta daclizumab, Odefsey rilpivirine/emtricitabine/tenofovir alafenamide and Ongentys opicapone. …

    Published on 4/29/2016
  • COMPANY NEWS: Amgen beats Street, again raises 2016 guidance

    On Thursday, Amgen Inc. (NASDAQ:AMGN) reported 1Q16 financial results that beat estimates and raised its 2016 EPS and revenue guidances yet again. Revenues in the quarter were $5.5 billion, up from $5 billion in 1Q15 …

    Published on 4/28/2016
  • COMPANY NEWS: Celgene lowers 2017 guidance on exchange headwinds

    Celgene Corp. (NASDAQ:CELG) reported 1Q16 financial results on Thursday and, as expected, lowered its 2017 financial guidance due to changing foreign exchange rates. The company had signaled in January that it planned …

    Published on 4/28/2016
  • COMPANY NEWS: Express Scripts outlines new programs

    In a blog post, Express Scripts Holding Co. (NASDAQ:ESRX) CMO Steven Miller outlined three new efforts to help control drug costs, including treatments for diabetes and inflammatory/autoimmune diseases. The PBM is …

    Published on 4/28/2016
  • COMPANY NEWS: Sanofi discloses Medivation offer

    Sanofi (Euronext:SAN; NYSE:SNY) said it made a non-binding offer to acquire Medivation Inc. (NASDAQ:MDVN) for $52.50 per share in cash, or about $9.3 billion. The price is a 40% premium to Medivation's close of $37.39 …

    Published on 4/28/2016
  • COMPANY NEWS: United Therapeutics falls on earnings, management news

    United Therapeutics Corp. (NASDAQ:UTHR) lost $12.84 (11%) to $104.84 on Thursday after reporting 1Q16 earnings that missed consensus estimates and announcing the departure of two of its top executives.The company …

    Published on 4/28/2016
  • COMPANY NEWS: Biogen names Ehlers R&D head

    Biogen Inc. (NASDAQ:BIIB) hired Michael Ehlers as EVP of R&D, effective in late May. Douglas Williams vacated the position in July 2015 to head Codiak BioSciences Inc. (Cambridge, Mass.) (see BioCentury Extra, July 10, …

    Published on 4/27/2016
  • COMPANY NEWS: Dynavax slides after FDA extends review of Heplisav-B

    Dynavax Technologies Corp. (NASDAQ:DVAX) fell $2.45 (12%) to $18.53 on Wednesday after it said FDA extended by three months its review of a BLA for Heplisav-B to prevent HBV in adults. The new PDUFA date is Dec. 15; it …

    Published on 4/27/2016
  • COMPANY NEWS: FDA accepts Opko's resubmitted Rayaldee NDA

    Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK) said FDA accepted for filing a resubmitted NDA for Rayaldee calcifediol to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease (CKD) and …

    Published on 4/27/2016
  • COMPANY NEWS: FDA rebuffs NDA for Abilify with Proteus' sensor

    FDA issued a complete response letter for an NDA from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) seeking approval of its Digital Medicine combination product, which includes Otsuka's antipsychotic Abilify …

    Published on 4/27/2016

< 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