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Chronological Index of : Company News

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  • COMPANY NEWS: Management tracks

    Cancer and neurology company e-Therapeutics plc (LSE:ETX) said Malcolm Young resigned as CEO and a director. The company is searching for a replacement.Gene therapy company Calimmune Inc. (Tucson, Ariz.) promoted …

    Published on 7/18/2016
  • COMPANY NEWS: Elite's opioid gets complete response letter

    Elite Pharmaceuticals Inc. (OTCQB:ELTP) received an FDA complete response letter for an NDA for SequestOx (ELI-200), an abuse deterrent formulation of oxycodone and naltrexone to treat moderate to severe pain where the …

    Published on 7/15/2016
  • COMPANY NEWS: FDA reviewers mixed on brodalumab's safety

    In briefing documents released ahead of an advisory committee meeting, FDA reviewers focused on two main safety concerns with psoriasis compound brodalumab (KHK4827) from Valeant Pharmaceuticals International Inc. (TSX;…

    Published on 7/15/2016
  • COMPANY NEWS: NICE denies United Therapeutics' Unituxin

    In final draft guidance, the U.K.'s NICE recommended against Unituxin dinutuximab from United Therapeutics Corp. (NASDAQ:UTHR) in combination with GM-CSF to treat high-risk neuroblastoma in pediatric patients. NICE said…

    Published on 7/15/2016
  • COMPANY NEWS: Teva among new PhRMA members

    PhRMA said Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) and Jazz Pharmaceuticals plc (NASDAQ:JAZZ) joined the trade group. PhRMA also said AMAG Pharmaceuticals Inc. (NASDAQ…

    Published on 7/15/2016
  • COMPANY NEWS: Daiichi gets Japanese rights to Amgen's biosimilars

    Amgen Inc. (NASDAQ:AMGN) granted Daiichi Sankyo Co. Ltd. (Tokyo:4568) exclusive rights to commercialize nine biosimilars in Japan. Amgen will remain responsible for development and manufacturing and will have a right to…

    Published on 7/14/2016
  • COMPANY NEWS: Juno gets ADORA2A inhibitor in RedoxTherapies takeout

    Juno Therapeutics Inc. (NASDAQ:JUNO) acquired RedoxTherapies Inc. (Boston, Mass.) for $10 million in upfront cash and undisclosed milestones. The deal gives Juno vipadenant (V2006), a small molecule adenosine A2A …

    Published on 7/14/2016
  • COMPANY NEWS: Decibel hires Holtzman as CEO

    Hearing loss company Decibel Therapeutics Inc. (Cambridge, Mass.) named Steven Holtzman CEO. In March, Holtzman retired as EVP of corporate development at Biogen Inc. (NASDAQ:BIIB). He is the founder and former chairman…

    Published on 7/13/2016
  • COMPANY NEWS: Juno rebounds after FDA lifts hold

    Juno Therapeutics Inc. (NASDAQ:JUNO) gained $2.63 to $30.42 on Wednesday after reporting late Tuesday that FDA lifted a clinical hold on the company's Phase II ROCKET trial of T cell immunotherapy JCAR015 to treat …

    Published on 7/13/2016
  • COMPANY NEWS: Second Genome taps CEO, tops off series B

    Microbiome company Second Genome Inc. (South San Francisco, Calif.) named Glenn Nedwin president and CEO. He was CEO of environmental and agricultural microbiome company Taxon Biosciences Inc., which E. I. du Pont de …

    Published on 7/13/2016
  • COMPANY NEWS: Cell Medica acquiring Delenex

    Cell Medica Ltd. (London, U.K.) is acquiring Delenex Therapeutics AG (Zurich, Switzerland) for undisclosed terms. Cell Medica plans to use Delenex's PENTRA antibody fragment platform to develop next-generation chimeric …

    Published on 7/12/2016
  • COMPANY NEWS: FDA panel backs Amgen's biosimilar Humira

    FDA's Arthritis Advisory Committee voted unanimously Tuesday to recommend approval of ABP 501 from Amgen Inc. (NASDAQ:AMGN), a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV), for all of the …

    Published on 7/12/2016
  • COMPANY NEWS: Flagship merges microbiome companies Evelo, Epiva

    Flagship Ventures merged its portfolio companies Evelo Biosciences Inc. (Cambridge, Mass.) and Epiva Biosciences (Cambridge, Mass.). The merged entity will develop microbiome therapeutics that interact with the immune …

    Published on 7/12/2016
  • COMPANY NEWS: Management tracks

    Oncology company Ipsen Group (Euronext:IPN) hired David Meek as CEO effective July 18, replacing Marc de Garidel. Meek was EVP and president of the oncology division at Baxalta Inc., which Shire plc (LSE:SHP; NASDAQ:…

    Published on 7/12/2016
  • COMPANY NEWS: Merck doubling down on biotech hubs

    Merck & Co. Inc. (NYSE:MRK) plans to reduce its workforce by undisclosed amounts at its Kenilworth, N.J., and Rahway, N.J., sites, as well as its North Wales, Pa., screening facility. The company said the moves are part…

    Published on 7/12/2016
  • COMPANY NEWS: Nichi-Iko slips after Sagent deal

    Nichi-Iko Pharmaceutical Co. Ltd. (Tokyo:4541) dipped Y118 to Y1,974 on Tuesday after announcing plans to acquire Sagent Pharmaceuticals Inc. (NASDAQ:SGNT) for about $736 million. The companies said the deal would give …

    Published on 7/12/2016
  • COMPANY NEWS: Seres to use Emulate's Intestine-Chip

    Microbiome company Seres Therapeutics Inc. (NASDAQ:MCRB) and organ-on-chip play Emulate Inc. (Boston, Mass.) partnered to use Emulate's Intestine-Chip platform to identify bacteria compositions with therapeutic …

    Published on 7/12/2016
  • COMPANY NEWS: X-Chem, Bayer expand drug discovery deal

    X-Chem Inc. (Waltham, Mass.) and Bayer AG (Xetra:BAYN) expanded their drug discovery collaboration to include multiple undisclosed therapeutic areas and target classes. The companies began collaborating in 2012, but …

    Published on 7/12/2016
  • COMPANY NEWS: FDA approves Shire's Xiidra

    Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Xiidra lifitegrast (SHP606) to treat signs and symptoms of dry eye disease in adults. The company expects to launch Xiidra this quarter.Shire obtained Xiidra via its …

    Published on 7/11/2016
  • COMPANY NEWS: FDA reviewers back similarity of Sandoz's Enbrel biosimilar

    In briefing documents released ahead of an advisory committee meeting, FDA reviewers concluded the "totality of the evidence" supports the biosimilarity of GP2015 from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN)…

    Published on 7/11/2016
  • COMPANY NEWS: Nichi-Iko acquiring Sagent

    Nichi-Iko Pharmaceutical Co. Ltd. (Tokyo:4541) said it will acquire generics company Sagent Pharmaceuticals Inc. (NASDAQ:SGNT) for $21.75 per share in cash, a 40% premium to Sagent's July 8 close of $15.50. The …

    Published on 7/11/2016
  • COMPANY NEWS: Servier gets rights to Sorrento's preclinical PD-1 mAb

    Sorrento Therapeutics Inc. (NASDAQ:SRNE) granted Servier (Neuilly-sur-Seine, France) an exclusive, worldwide license to STI-A1110, a preclinical mAb against PD-1. Servier expects to study STI-A1110 in combination with …

    Published on 7/11/2016
  • COMPANY NEWS: FDA reviewers back extrapolation for Amgen's biosimilar Humira

    FDA reviewers concluded the "totality of the evidence" support the biosimilarity of ABP 501 from Amgen Inc. (NASDAQ:AMGN) to Humira adalimumab from AbbVie Inc. (NYSE:ABBV), its U.S.-licensed reference product. In …

    Published on 7/8/2016
  • COMPANY NEWS: Management tracks

    Oncology company Lion Biotechnologies Inc. (NASDAQ:LBIO) said CFO Molly Henderson will resign, effective Aug. 16. Neurology company Ovid Therapeutics Inc. (New York, N.Y.) promoted Yaron Werber to CBO, while remaining …

    Published on 7/8/2016
  • COMPANY NEWS: AC Immune gets another Genentech milestone

    AC Immune S.A. (Lausanne, Switzerland) received a CHF14 million ($14.4 million) milestone payment from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) triggered by dosing of the first patient in a Phase I study …

    Published on 7/7/2016

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