19:58 , Jun 15, 2018 |  BC Week In Review  |  Clinical News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve...
22:40 , Jun 14, 2018 |  BC Extra  |  Company News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve...
23:07 , Jun 5, 2018 |  BC Extra  |  Company News

Management tracks: Sarepta, Gilead

Neuromuscular disease company Sarepta Therapeutics Inc. (NASDAQ:SRPT) hired Louise Rodino-Klapac as VP of gene therapy at its newly created gene therapy unit. She will continue to serve as acting CSO at Myonexus Therapeutics Inc. (New...
19:59 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

Sandoz gets CRL for generic Advair

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year...
23:58 , Feb 8, 2018 |  BC Extra  |  Company News

GSK breathes easier after delay for Sandoz’s generic Advair

Sandoz said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year as planned after the Novartis AG (NYSE:NVS;...
23:36 , Jan 17, 2018 |  BC Extra  |  Company News

Management tracks: NanoString, Orchard

Molecular diagnostics company NanoString Technologies Inc. (NASDAQ:NSTG) hired Thomas Bailey as CFO. He was CFO of AgaMatrix Holdings LLC (Salem, N.H.). Gene therapy company Orchard Therapeutics Ltd. (London, U.K.) hired Frank Thomas as CFO and CBO....
07:16 , Jul 29, 2017 |  BioCentury  |  Finance

Show us your shorts

Absent any data showing a sustained impact of manipulative short selling on biotech valuations or their ability to raise capital, it is difficult to discern what direct benefit biotech companies would gain from BIO’s call...
23:00 , Jun 30, 2017 |  BC Extra  |  Company News

Management tracks

Cell therapy play BlueRock Therapeutics (Toronto, Ontario) named Emile Nuwaysir president and CEO, and Robert Deans chief technology officer. Nuwaysir was president and COO at Cellular Dynamics International Inc., which Fujifilm Holdings Corp. (Tokyo:4901) acquired...
20:03 , Apr 7, 2017 |  BC Week In Review  |  Company News

Jazz, Hikma deal

Jazz granted Hikma rights to market an authorized generic version of narcolepsy drug Xyrem sodium oxybate starting on Jan. 1, 2023. The agreement settles patent litigation between Jazz and Roxane Laboratories Inc., which Hikma acquired...
19:42 , Apr 7, 2017 |  BC Week In Review  |  Company News

Acorda patent challenge and restructuring news

The U.S. District Court for the District of Delaware invalidated four of the five Orange Book-listed patents protecting Acorda’s multiple sclerosis drug Ampyra dalfampridine on grounds of obviousness. Acorda said it plans to appeal the...