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  • 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
  • COMPANY NEWS: Management tracks

    Cancer company ImmunoGen Inc. (NASDAQ:IMGN) hired Mark Enyedy as president, CEO and a director, effective May 16. Enyedy was EVP and head of corporate development at Shire plc (LSE:SHP; NASDAQ:SHPG). He replaces Daniel …

    Published on 4/27/2016
  • COMPANY NEWS: Valeant's Pearson regrets drug pricing decisions

    On Wednesday, Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) CEO Michael Pearson testified before the U.S. Senate Committee on Aging as part of the committee's drug pricing investigation. Pearson said …

    Published on 4/27/2016
  • COMPANY NEWS: Collegium's Xtampza ER gets FDA nod

    Collegium Pharmaceutical Inc. (NASDAQ:COLL) gained $2.52 (14%) to $20.95 in early after-hours trading Tuesday after it said FDA approved Xtampza ER oxycodone extended-release to manage pain severe enough to require …

    Published on 4/26/2016
  • COMPANY NEWS: FDA approves AZ's Bevespi Aerosphere for COPD

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA approved Bevespi Aerosphere (PT003) for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Bevespi Aerosphere …

    Published on 4/26/2016
  • COMPANY NEWS: Ironwood gets U.S. rights to AZ's Zurampic

    AstraZeneca plc (LSE:AZN; NYSE:AZN) granted Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) exclusive, U.S. rights to Zurampic lesinurad, which FDA approved in December in combination with a xanthine oxidase inhibitor to …

    Published on 4/26/2016
  • COMPANY NEWS: NICE backs Novartis' Entresto

    The U.K.'s NICE issued draft guidance recommending heart failure drug Entresto sacubitril/valsartan from Novartis AG (NYSE:NVS; SIX:NOVN). The drug is recommended for patients with moderate to very severe symptoms with …

    Published on 4/26/2016
  • COMPANY NEWS: Sarepta sinks after eteplirsen panel

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) sank $3.93 (26%) to $11.02 on Tuesday after an FDA advisory committee voted Monday that the company did not provide substantial evidence that eteplirsen (AVI-4658) is effective to…

    Published on 4/26/2016
  • COMPANY NEWS: Zymeworks, GSK in second antibody deal

    Zymeworks Inc. (Vancouver, B.C.) granted GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) an option to license molecules developed using the biotech's Azymetric bispecific antibody discovery platform.The companies partnered in …

    Published on 4/26/2016
  • COMPANY NEWS: FDA approves Exelixis' Cabometyx for RCC

    FDA approved an NDA from Exelixis Inc. (NASDAQ:EXEL) for a tablet formulation of Cabometyx cabozantinib (XL184) as second-line therapy to treat advanced renal cell carcinoma in patients who have received prior anti-…

    Published on 4/25/2016
  • COMPANY NEWS: Perrigo's Papa to take helm at Valeant

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) named Joseph Papa chairman and CEO, effective in early May. He will replace longtime CEO Michael Pearson, who was also chairman until late February. Robert …

    Published on 4/25/2016
  • COMPANY NEWS: Unity, Ascentage in cellular senescence deal

    Anti-aging company Unity Biotechnology (San Francisco, Calif.) and Ascentage Pharma Group Corp. Ltd. (Hong Kong, China) partnered to develop small molecules to treat age-related diseases by selectively inducing death of…

    Published on 4/25/2016
  • COMPANY NEWS: Express Scripts eyes Ocrevus, dupilumab

    In comments to the American Journal of Managed Care, Express Scripts Holding Co. (NASDAQ:ESRX) Senior Clinical Consultant of Emerging Therapeutics Aimee Tharaldson said she is closely watching the progress of multiple …

    Published on 4/22/2016

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