BioCentury | Jul 6, 2020
Product Development

July 6 Quick Takes: Cellectis CAR T trial halted; plus data readouts from Bellus, ObsEva, Idorsia, and more

Patient death prompts Cellectis trial halt  FDA placed a clinical hold on an allogeneic CAR T therapy trial to treat multiple myeloma from Cellectis S.A. (NASDAQ:CLLS; Euronext:ALCLS) after a patient who received the second-level dose...
BioCentury | Apr 21, 2020
Product Development

April 20 Quick Takes: Top-line data for BMS, Idorsia and Ascendis; plus Otsuka-Esperion, Regeneron and more

BMS combo meets in Phase III for malignant pleural mesothelioma  Bristol Myers Squibb Co. (NYSE:BMY) said top-line results from the Phase III CheckMate -743 trial showed a combination of anti-PD-1 mAb Opdivo nivolumab and anti-CTLA4...
BC Extra | Jan 15, 2020
Financial News

Jan. 14 Financial Quick Takes: Schrödinger proposes NASDAQ IPO; plus Mirati, Blackstone, Orexia, Jasper, seqWell

Schrödinger seeking NASDAQ listing  Computational physics and drug discovery company Schrödinger Inc. proposed to raise up to $100 million in an IPO on NASDAQ. The company’s largest shareholders are the Bill and Melinda Gates Foundation...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BC Innovations | Nov 15, 2019
Product Development

Minerva on the verge in neuropsychiatry with two compounds close to verdict

Minerva Neurosciences is on the precipice of two clinical readouts that could determine whether its founding bet on a pair of neuropsychiatry compounds from Mitsubishi Tanabe has panned out. Neither molecule represents a shift from...
BioCentury | Feb 8, 2019
Finance

Medicxi’s orexin dream deal

Sleep disorder spinouts Orexia Ltd. and Inexia Ltd. were created to marry Medicxi’s keen interest in agonizing orexin and Heptares Therapeutics Ltd.’s desire to find creative ways to fund its pipeline. Medicxi will invest up...
BC Week In Review | Oct 19, 2018
Clinical News

Eisai, Purdue insomnia candidate meets in second Phase III

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) said lemborexant met the primary and secondary endpoints in the Phase III SUNRISE 2 trial to treat insomnia. The trial is the second Phase III...
BC Extra | Oct 17, 2018
Clinical News

Eisai, Purdue insomnia candidate meets in second Phase III

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) said lemborexant met the primary and secondary endpoints in the Phase III SUNRISE 2 trial to treat insomnia. The trial is the second Phase III...
BC Week In Review | Jun 15, 2018
Clinical News

Eisai, Purdue's insomnia candidate does not impair driving in Phase I

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) reported top-line data from the Phase I Study 106 showing that insomnia candidate lemborexant (E2006) given each night at bedtime met the primary endpoint of...
BC Week In Review | Jun 15, 2018
Clinical News

Eisai, Purdue's insomnia candidate improves postural stability in Phase I

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) reported top-line data from the Phase I Study 108 showing that both doses of insomnia candidate lemborexant (E2006) given each night at bedtime met the...
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