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

Chronological Index of : Company News

 Current Issue
  • COMPANY NEWS: Management tracks

    Diagnostics company Exact Sciences Corp. (NASDAQ:EXAS) promoted Jeff Elliott to CFO from VP of business development and strategy. He replaces the retiring John Bakewell.Neurology company vasopharm GmbH (Wuerzburg, …

    Published on 11/17/2016
  • COMPANY NEWS: BMS, Enterome in microbiome immuno-oncology deal

    Bristol-Myers Squibb Co. (NYSE:BMY) and Enterome Bioscience S.A. (Paris, France) partnered to discover and develop microbiome-associated biomarkers, targets, therapeutic molecules and companion diagnostics to treat …

    Published on 11/16/2016
  • COMPANY NEWS: Genexine gets Orphan designation for GHD therapy

    Genexine Inc. (KOSDAQ:095700) said FDA granted Orphan Drug designation to the company's GX-H9 to treat growth hormone deficiency (GHD).The company expects full data this year from a Phase II trial of GX-H9 to treat …

    Published on 11/16/2016
  • COMPANY NEWS: Amgen, Allergan submit Avastin biosimilar

    Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) said they submitted a BLA to FDA for ABP 215, a biosimilar of Avastin bevacizumab from the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY). The partners said they …

    Published on 11/15/2016
  • COMPANY NEWS: Roche launches imCORE immunotherapy network

    Roche (SIX:ROG; OTCQX:RHHBY) said it has launched its cancer immunotherapy Centers of Research Excellence (imCORE) Network with researchers from 21 academic institutions.The pharma said it will invest up to CHF100 …

    Published on 11/15/2016
  • COMPANY NEWS: uniQure paring down gene therapy portfolio

    Gene therapy company uniQure N.V. (NASDAQ:QURE) said it will reduce headcount by 20-25%, eliminating 50-60 positions by YE17, in order to focus on key pipeline projects.The company expects the job cuts will save EUR 5-6…

    Published on 11/15/2016
  • COMPANY NEWS: Dynavax looking for Plan B for Heplisav-B

    Dynavax Technologies Corp. (NASDAQ:DVAX) fell $7.50 (65%) to $4.10 on Monday after it received a complete response letter from FDA for the biotech's Heplisav-B HBV vaccine and said it now wants a partner to help keep …

    Published on 11/14/2016
  • COMPANY NEWS: Priority Review for Novartis' midostaurin

    Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted and granted Priority Review to an NDA for midostaurin (PKC412; CGP 41251) to treat newly diagnosed FLT3 mutation-positive acute myelogenous leukemia (AML) as well as …

    Published on 11/14/2016
  • COMPANY NEWS: CHMP recommendations include HBV drug Vemlidy

    EMA's CHMP backed approval of a host of candidates on Friday, including Vemlidy tenofovir alafenamide fumarate (TAF; GS-7340) from Gilead Sciences Inc. (NASDAQ:GILD) to treat HBV.CHMP recommended Vemlidy's approval to …

    Published on 11/11/2016
  • COMPANY NEWS: Eagle acquiring drug delivery company Arsia

    Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) is to acquire drug formulation and delivery company Arsia Therapeutics Inc. (Waltham, Mass.) for $30 million, including $27.3 million in cash and $2.7 million in Eagle stock. …

    Published on 11/11/2016
  • COMPANY NEWS: Ultragenyx withdraws MAA for HIBM therapy

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said Friday that it withdrew an MAA for Ace-ER (UX001) to treat GNE myopathy, a muscle-wasting disorder also known as hereditary inclusion body myopathy. The company had …

    Published on 11/11/2016
  • COMPANY NEWS: AZ slows durvalumab's development path in SCCHN

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said that due to a changing marketplace, it no longer intends to submit regulatory applications for PD-L1 inhibitor durvalumab (MEDI4736) to treat squamous cell carcinoma of the head …

    Published on 11/10/2016
  • COMPANY NEWS: FDA approves Gilead's Vemlidy for HBV

    Gilead Sciences Inc. (NASDAQ:GILD) said FDA approved its once-daily tablet Vemlidy tenofovir alafenamide (TAF; GS-7340) to treat chronic HBV infection in patients with compensated liver disease. Gilead spokesperson …

    Published on 11/10/2016
  • COMPANY NEWS: FDA approves Opdivo for head and neck cancer

    FDA approved an sBLA from Bristol-Myers Squibb Co. (NYSE:BMY) for Opdivo nivolumab to treat recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-…

    Published on 11/10/2016
  • COMPANY NEWS: Lilly grants Eddingpharm antibiotic rights in China

    Eli Lilly and Co. (NYSE:LLY) granted Eddingpharm Inc. (Shanghai, China) exclusive rights to promote and distribute antibiotics Ceclor cefaclor and Vancocin vancomycin in mainland China, effective Jan. 1, 2017. Lilly …

    Published on 11/10/2016
  • COMPANY NEWS: Kite updates KTE-C19 timeline

    In its 3Q16 earnings report, Kite Pharma Inc. (NASDAQ:KITE) said it hopes to begin by YE16 the submission of a rolling BLA to FDA for its chimeric antigen receptor (CAR) T cell therapy KTE-C19 to treat non-Hodgkin's …

    Published on 11/9/2016
  • COMPANY NEWS: FDA reviewing Emmaus' sickle cell therapy

    Emmaus Life Sciences Inc. (Torrance, Calif.) said FDA accepted an NDA for its pharmaceutical-grade L-glutamine to treat sickle cell disease. The company said it is awaiting notice from FDA regarding its Priority Review …

    Published on 11/8/2016
  • COMPANY NEWS: Mylan submits Herceptin biosimilar to FDA

    Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said Mylan submitted a BLA to FDA for Myl-1401O, their proposed biosimilar of Herceptin trastuzumab, to treat HER2-positive breast and gastric …

    Published on 11/8/2016
  • COMPANY NEWS: Management tracks

    Cancer company Neon Therapeutics Inc. (Cambridge, Mass.) named Richard Gaynor president of R&D. He was SVP of global product development and medical affairs in the oncology division at Eli Lilly and Co. (NYSE:LLY).Rare …

    Published on 11/7/2016
  • COMPANY NEWS: Molecular Partners CEO Zahnd resigns

    Molecular Partners AG (SIX:MOLN) said CEO Christian Zahnd resigned due to health reasons. Zahnd will remain a member of the board. CBO and COO Patrick Amstutz will be interim CEO as the company searches for Zahnd's …

    Published on 11/7/2016
  • COMPANY NEWS: PTAB denies Coherus' Humira IPR challenge

    Coherus BioSciences Inc. (NASDAQ:CHRS) lost $2.55 to $25.60 on Monday after the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office denied its inter partes review petition challenging U.S. Patent No. 9…

    Published on 11/7/2016
  • COMPANY NEWS: Califf gives rationale for deferring Sarepta decision

    FDA Commissioner Robert Califf chose not to make the approval decision for Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT) because he believes that decisions about products should be left to career …

    Published on 11/4/2016
  • COMPANY NEWS: Management tracks

    Gene editing company Casebia Therapeutics (Cambridge, Mass.), a JV formed by Bayer AG (Xetra:BAYN) and CRISPR Therapeutics AG (NASDAQ:CRSP), named James Burns president and CEO. He was head of the North American R&D hub…

    Published on 11/4/2016
  • COMPANY NEWS: EMA reviewing Lantus biosimilar

    Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for the partners' biosimilar insulin glargine to treat Type I and Type II diabetes. The companies said the MAA …

    Published on 11/3/2016
  • COMPANY NEWS: Infinity finds new taker for duvelisib

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) granted Verastem Inc. (NASDAQ:VSTM) exclusive, worldwide rights to develop and commercialize duvelisib (IPI-145), an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta …

    Published on 11/2/2016

< Previous   1  2  3  4  5  6  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993