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  • COMPANY NEWS: Humira buoys AbbVie as HCV market share shrinks

    AbbVie Inc. (NYSE:ABBV) reported 2Q16 financial results that beat estimates and raised full-year 2016 guidance. Continued strength in sales of autoimmune drug Humira adalimumab allayed some concerns about AbbVie's …

    Published on 7/29/2016
  • COMPANY NEWS: Takeda restructuring R&D in U.S., Japan

    In a new restructuring plan unveiled Friday, Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said it plans to "reduce and concentrate" its R&D in Japan and the U.S.In a presentation, CMO and CSO Andrew Plump said Takeda's R…

    Published on 7/29/2016
  • COMPANY NEWS: Alexion's Strensiq beats expectations

    In its 2Q16 financial results, Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) raised its full-year guidance for its metabolic programs after sales of hypophosphatasia drug Strensiq asfotase alfa exceeded expectations.…

    Published on 7/28/2016
  • COMPANY NEWS: AZ looks to pipeline, launches to offset patent cliff

    In the company's 2Q16 financial presentation on Thursday, AstraZeneca plc (NYSE:AZN; LSE:AZN) CEO Pascal Soriot stressed pipeline progress and growth from new product launches as the company rebuilds from the loss of …

    Published on 7/28/2016
  • COMPANY NEWS: BMS beats estimates, raises guidance

    Bristol-Myers Squibb Co. (NYSE:BMY) reported 2Q16 financial results that beat estimates, and raised its EPS guidance for the year. Revenues in the quarter were $4.87 billion, up from $4.16 billion in 2Q15 and topping …

    Published on 7/28/2016
  • COMPANY NEWS: Editas in three-year research deal with SR-TIGET

    Gene editing company Editas Medicine Inc. (NASDAQ:EDIT) partnered with Fondazione Telethon (Milan, Italy) and Ospedale San Raffaele (Milan, Italy) to focus on R&D of genome-edited hematopoietic stem cell and T cell …

    Published on 7/28/2016
  • COMPANY NEWS: FDA approves Sanofi's lixisenatide

    FDA approved Adlyxin lixisenatide from Sanofi (Euronext:SAN: NYSE:SNY) as an adjunct to diet and exercise to treat Type II diabetes. The once-daily glucagon-like peptide-1 receptor (GLP-1R; GLP1R) agonist is marketed as…

    Published on 7/28/2016
  • COMPANY NEWS: Luoxin picks up NSCLC candidate from Yuhan

    Yuhan Corp. (KSE:000100) granted Shandong Luoxin Pharmaceutical Group Stock Co. Ltd. (HKSE:8058) exclusive rights to EGFR-mutation positive non-small cell lung cancer candidate YH25448 in Greater China, including …

    Published on 7/28/2016
  • COMPANY NEWS: Priority Review for BioMarin's Batten therapy

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said FDA accepted and granted Priority Review to a BLA for Brineura cerliponase alfa (BMN 190) to treat children with neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a …

    Published on 7/28/2016
  • COMPANY NEWS: Amgen again lifts 2016 guidance, tops consensus

    Amgen Inc. (NASDAQ:AMGN) reported 2Q16 financial results that beat estimates and again raised its full-year guidance. The company reported quarterly revenues of $5.69 billion, up from $5.37 billion in 2Q15 and beating …

    Published on 7/27/2016
  • COMPANY NEWS: Cytokinetics, Astellas add ALS to existing deal

    Cytokinetics Inc. (NASDAQ:CYTK) and Astellas Pharma Inc. (Tokyo:4503) expanded their skeletal muscle activator collaboration to add a focus on amyotrophic lateral sclerosis and extend through 2017 their joint program to…

    Published on 7/27/2016
  • COMPANY NEWS: GSK picks up asthma candidate from J&J

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it obtained exclusive, worldwide rights to CNTO 7160 from the Janssen Sciences Ireland UC unit of Johnson & Johnson (NYSE:JNJ). The mAb against IL-33 receptor is in a Phase I…

    Published on 7/27/2016
  • COMPANY NEWS: LabCorp acquiring Sequenom

    Diagnostics company Laboratory Corp. of America Holdings (NYSE:LH) is acquiring Sequenom Inc. (NASDAQ:SQNM) for $2.40 per share, or about $371 million including Sequenom's net debt. The price is a 182% premium to …

    Published on 7/27/2016
  • COMPANY NEWS: Merck ending allergy tablet deal with ALK-Abello

    ALK-Abello A/S(CSE:ALK-B) fell DKK206 (18%) to DKK968 on Wednesday after it said Merck & Co. Inc. (NYSE:MRK) will return North American rights to the biotech's sublingual allergy immunotherapy (SLIT) tablets. ALK-Abello…

    Published on 7/27/2016
  • COMPANY NEWS: NICE recommends Opdivo-Yervoy combo

    In final guidance released Wednesday, the U.K.'s NICE recommended Opdivo nivolumab in combination with Yervoy ipilimumab to treat advanced melanoma. NICE said it completed its appraisal 24 working days after the combo …

    Published on 7/27/2016
  • COMPANY NEWS: Vertex stands by Orkambi, Kalydeco guidance

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) reported modest upticks in 2Q16 sales of cystic fibrosis drugs Orkambi ivacaftor/lumacaftor and Kalydeco ivacaftor.The biotech reported $245.5 million in global sales of Orkambi…

    Published on 7/27/2016
  • COMPANY NEWS: Darzalex adds breakthrough designation for second-line MM

    Genmab A/S (CSE:GEN) said FDA granted Darzalex daratumumab breakthrough therapy designation in combination with Revlimid lenalidomide and dexamethasone, or with Velcade bortezomib and dexamethasone, as a second-line …

    Published on 7/26/2016
  • COMPANY NEWS: Gilead sinks as HCV sales decline

    Gilead Sciences Inc. (NASDAQ:GILD) fell $7.50 to $81.05 on Tuesday, shedding about $10 billion in market cap. On Monday after market close, it lowered its 2016 guidance and reported 2Q16 earnings showing that its HCV …

    Published on 7/26/2016
  • COMPANY NEWS: Luye acquiring Acino's transdermal delivery business

    Luye Pharma Group Ltd. (HKSE:2186) is to acquire the transdermal drug delivery systems (TDS) business from delivery play Acino Holding AG (Aesch, Switzerland) for EUR 245 million ($268.6 million). Luye said it sees "…

    Published on 7/26/2016
  • COMPANY NEWS: Newron's Xadago heading for resubmission

    Newron Pharmaceuticals S.p.A. (SIX:NWRN) said FDA will not require the company to conduct clinical studies of Parkinson's disease candidate Xadago safinamide to study its dependence and withdrawal effects or abuse …

    Published on 7/26/2016
  • COMPANY NEWS: FDA rejects Ocular's Dextenza

    Ocular Therapeutix Inc. (NASDAQ:OCUL) said it received a complete response letter from FDA for Dextenza (OTX-DP) to treat ocular pain following ophthalmic surgery. Ocular said the agency cited "deficiencies in …

    Published on 7/25/2016
  • COMPANY NEWS: Legal tracks

    Weeks after hiring patent attorney Mika Reiner Mayer as a partner, Cooley expanded its life sciences patent practice by adding Mayer's former team of 11 lawyers and patent agents from Morrison & Foerster. The hires …

    Published on 7/25/2016
  • COMPANY NEWS: CHMP backs pair of RCC drugs

    On Friday, EMA's CHMP recommended approval of two drugs to treat advanced renal cell carcinoma in patients previously treated with a VEGF inhibitor. The committee recommended Kisplyx lenvatinib from Eisai Co. Ltd. (…

    Published on 7/22/2016
  • COMPANY NEWS: CHMP recommendations include Truvada for PrEP

    EMA's CHMP backed approval of a host of drugs on Friday, and recommended expanding the label of HIV therapy Truvada emtricitabine/tenofovir disoproxil fumarate from Gilead Sciences Inc. (NASDAQ:GILD) to include pre-…

    Published on 7/22/2016
  • COMPANY NEWS: FDA rejects Valeant's Vesneo

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) received an FDA complete response letter for Vesneo latanoprostene bunod to treat open-angle glaucoma or intraocular pressure. Nicox S.A. (Euronext:COX), …

    Published on 7/22/2016

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