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  • COMPANY NEWS: Biogen, AGTC partner in ophthalmic gene therapy

    Biogen Inc. (NASDAQ:BIIB) and Applied Genetic Technologies Corp. (NASDAQ:AGTC) partnered to develop and commercialize gene therapies for ophthalmic diseases. AGTC will receive $124 million up front and is eligible for $…

    Published on 7/2/2015
  • COMPANY NEWS: CAFC invalidates Medicines Co.'s AngioMax patents

    The U.S. Court of Appeals for the Federal Circuit ruled that two patents covering Angiomax bivalirudin from The Medicines Co. (NASDAQ:MDCO) are invalid. The Medicines Co. had filed suit against Hospira Inc. (NYSE:HSP) …

    Published on 7/2/2015
  • COMPANY NEWS: AZ completes antibiotics spin-out

    AstraZeneca plc (LSE:AZN; NYSE:AZN) completed its previously announced spin-out of its early stage antibiotics programs into stand-alone company Entasis Therapeutics Inc. (Waltham, Mass.). AZ was the sole investor in …

    Published on 7/1/2015
  • COMPANY NEWS: Exelixis falls on delayed cobimetinib NDA review

    Exelixis Inc. (NASDAQ:EXEL) was off $0.27 to $3.49 on Wednesday after FDA pushed back the PDUFA date for melanoma therapeutic cobimetinib to Nov. 11 from Aug. 11. Exelixis said FDA changed the date after Exelixis' …

    Published on 7/1/2015
  • COMPANY NEWS: Gilead uses Priority Review voucher for HIV regimen

    Gilead Sciences Inc. (NASDAQ:GILD) submitted a Priority Review voucher along with an NDA to FDA for a single-tablet regimen combining its Emtriva emtricitabine and tenofovir alafenamide plus Edurant rilpivirine from …

    Published on 7/1/2015
  • COMPANY NEWS: Management tracks

    Cancer play NuCana BioMed Ltd. (Edinburgh, U.K.) named Chris McGuigan CSO. McGuigan is professor of medicinal chemistry at the Cardiff School of Pharmacy and Pharmaceutical Sciences and chair of Life Sciences Hub Wales …

    Published on 7/1/2015
  • COMPANY NEWS: Novo pulling Tresiba in Germany

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said Wednesday it will no longer market Tresiba insulin degludec in Germany after failing to agree on a price with Germany's Statutory Health Insurance Funds Association (GKV-…

    Published on 7/1/2015
  • COMPANY NEWS: Former broker sues Samuel Waksal, Kadmon

    Anastasios Belesis filed suit against Kadmon Corp. LLC (New York, N.Y.), Samuel Waksal and Steven Gordon in the U.S. District Court for the Southern District of New York alleging breach of contract. The former founder …

    Published on 6/30/2015
  • COMPANY NEWS: Juno rises following Celgene deal

    Juno Therapeutics Inc. (NASDAQ:JUNO) gained $7.03 (15%) to $53.33 on Tuesday after post-market news Monday that it formed a 10-year collaboration with Celgene Corp. (NASDAQ:CELG) to develop immunotherapies for cancer …

    Published on 6/30/2015
  • COMPANY NEWS: Management tracks

    Merck & Co. Inc. (NYSE:MRK) and the Sanofi Pasteur S.A. vaccines unit of Sanofi (Euronext:SAN; NYSE:SNY) hired David Khougazian as president of their Sanofi Pasteur MSD joint venture. Khougazian was Sanofi's CEO chief …

    Published on 6/30/2015
  • COMPANY NEWS: AMAG acquires Cord Blood Registry

    AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) will acquire stem cell company Cord Blood Registry (San Bruno, Calif.) for $700 million in cash. CBR stores more than 600,000 preserved umbilical cord blood and tissue stem cell …

    Published on 6/29/2015
  • COMPANY NEWS: Amgen files IPRs against Humira patents

    Amgen Inc. (NASDAQ:AMGN) filed two inter partes review (IPR) petitions with the U.S. Patent and Trademark Office challenging patents from AbbVie Inc. (NYSE:ABBV) covering a formulation of Humira adalimumab. Amgen …

    Published on 6/29/2015
  • COMPANY NEWS: BioMarin, Sarepta DMD submissions move forward

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) and Sarepta Therapeutics Inc. (NASDAQ:SRPT) each provided regulatory updates for their Duchenne muscular dystrophy programs on Monday. BioMarin said FDA accepted and granted …

    Published on 6/29/2015
  • COMPANY NEWS: Immunocore, Lilly partner for melanoma combos

    Immunocore Ltd. (Abingdon, U.K.) partnered with Eli Lilly and Co. (NYSE:LLY) to study combination regimens including Immunocore's IMCgp100 and Lilly's galunisertib (LY2157299) and merestinib (LY2801653) to treat …

    Published on 6/29/2015
  • COMPANY NEWS: Intercept submits OCA NDA

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said it submitted an NDA to FDA for accelerated approval of OCA obeticholic acid to treat primary biliary cirrhosis (PBC). The company also said EMA accepted for review an …

    Published on 6/29/2015
  • COMPANY NEWS: Novartis acquires pain play Spinifex

    Novartis AG (NYSE:NVS; SIX:NOVN) will acquire chronic pain treatment developer Spinifex Pharmaceuticals Pty. Ltd. (Preston, Australia) for $200 million up front. Spinifex shareholders are eligible for undisclosed …

    Published on 6/29/2015
  • COMPANY NEWS: Actelion, Max Planck launch vaccine play Vaxxilon

    Actelion Ltd. (SIX:ATLN) and the Max Planck Society launched Vaxxilon AG (Reinach, Switzerland), a newco focused on developing synthetic carbohydrate vaccines.Vaxxilon licensed exclusive rights to multiple preclinical …

    Published on 6/26/2015
  • COMPANY NEWS: CHMP backs therapies from Alexion, Novartis, Santhera

    EMA's CHMP issued several recommendations on Friday, backing approval of MAAs for candidates from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Novartis AG (NYSE:NVS; SIX:NOVN) and Santhera Pharmaceuticals Holding AG (SIX…

    Published on 6/26/2015
  • COMPANY NEWS: EMA to review drisapersen, Galafold, Alprolix

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said EMA accepted for review an MAA for drisapersen to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. In April, BioMarin completed submission of a …

    Published on 6/26/2015
  • COMPANY NEWS: Management tracks

    CNS company KemPharm Inc. (NASDAQ:KMPH) promoted LaDuane Clifton to CFO from VP of finance and corporate controller. He replaces Gordon Johnson, who became CBO.Food allergy company DBV Technologies S.A. (Euronext:DBV; …

    Published on 6/26/2015
  • COMPANY NEWS: BMS ending virology discovery, building Cambridge hub

    Bristol-Myers Squibb Co. (NYSE:BMY) said it will discontinue drug discovery in virology as part of an ongoing R&D reorganization. The company said the change will not affect its clinical-stage and marketed virology …

    Published on 6/25/2015
  • COMPANY NEWS: Management tracks

    Rare disease play Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) hired Gregory Perry as CFO. Perry was CFO at Eleven Biotherapeutics Inc. (NASDAQ:EBIO).Inhalable therapies company Pulmatrix Inc. (NASDAQ:PULM) hired William…

    Published on 6/25/2015
  • COMPANY NEWS: Merrimack's MM-398 gets Priority Review

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) and the Baxalta Inc. subsidiary of Baxter International Inc. (NYSE:BAX) said FDA accepted and granted Priority Review to an NDA for MM-398 as second-line treatment for …

    Published on 6/25/2015
  • COMPANY NEWS: Allergan sues hedge fund in response to Combigan IPR

    Allergan plc (NYSE:AGN) filed suit against Ferrum Ferro Capital in the U.S. District Court for the Central District of California, alleging the hedge fund attempted to extort the company "by misusing the inter partes …

    Published on 6/24/2015
  • COMPANY NEWS: Biocartis launches KRAS diagnostic

    Biocartis Group N.V. (Euronext:BCART) launched the Idylla KRAS Mutation Test to detect clinically relevant mutations in colorectal cancer (CRC). The company said the in vitro diagnostic received CE-IVD marking.Biocartis…

    Published on 6/24/2015

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