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...
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...
BC Week In Review | Mar 16, 2018
Clinical News

Eisai, Purdue's lemborexant meets in Phase III for insomnia

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) reported top-line data from the Phase III SUNRISE 1 trial in about 1,000 patients ages 55 and older with insomnia showing that oral lemborexant (E2006)...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Nov 10, 2016
Clinical News

Lemborexant: Ph II started

Eisai began the double-blind, placebo-controlled, international Phase II Study 202 to evaluate 2.5, 5, 10 and 15 mg oral lemborexant for 4 weeks in about 125 patients ages 65-90 with ISWRD and mild to moderate...
BC Week In Review | Oct 5, 2015
Company News

Eisai, Purdue Pharma deal

Eisai’s Eisai Inc. subsidiary and Purdue partnered to develop and commercialize Eisai’s lemborexant ( E2006 ) to treat insomnia, for which it has completed Phase II testing. The deal may be expanded to include other indications. The...
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