22:52 , May 2, 2019 |  BC Extra  |  Clinical News

May 2 Clinical Quick Takes: Biogen, GSK, Celgene/bluebird, Genkyotex

Biogen's ALS candidate reduces SOD1 protein levels in CSF  Biogen Inc. (NASDAQ:BIIB) will present on May 7 at the American Academy of Neurology meeting the interim Phase I/II data of tofersen that had prompted it...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
21:54 , Oct 31, 2018 |  BC Extra  |  Company News

GSK cuts some respiratory targets, keeps others in play

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) cut three respiratory programs against targets largely ignored by the rest of the industry after all three failed to meet efficacy targets in Phase II trials. The pharma disclosed the pruning...
21:48 , Apr 27, 2018 |  BioCentury  |  Regulation

Independent opportunities

The scenario the U.K. is trying to avoid is a full disconnect from EMA when the Brexit curtain falls. But a clean break from the agency could create opportunities for the U.K.’s Medicines and Healthcare...
18:49 , Oct 20, 2017 |  BioCentury  |  Regulation

Realities of real-world evidence

After countless conferences, white papers and speeches, stakeholders across the healthcare ecosystem are finally coming together to figure out how to extend the use of real-world evidence beyond pharmacovigilance and into drug development. The payoffs...
19:53 , Sep 22, 2017 |  BC Week In Review  |  Clinical News

GSK's Trelegy Ellipta meets in Phase III IMPACT trial for COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) reported data from the Phase III IMPACT trial in 10,355 chronic obstructive pulmonary disease (COPD) patients showing that once-daily Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) met the primary...
19:51 , Sep 22, 2017 |  BC Week In Review  |  Clinical News

FDA approves GSK's triple combo for COPD maintenance

FDA approved an NDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for maintenance treatment of chronic obstructive pulmonary disease. GSK said Trelegy Ellipta is the first once-daily single inhaler triple therapy approved...
22:09 , Sep 19, 2017 |  BC Extra  |  Company News

FDA approves GSK's triple combo for COPD maintenance

FDA approved an NDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for maintenance treatment of chronic obstructive pulmonary disease. GSK said Trelegy Ellipta is the first once-daily single inhaler triple therapy approved...
17:52 , Aug 11, 2017 |  BC Week In Review  |  Clinical News

GSK, Innoviva seek expanded Relvar Ellipta label

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) submitted to EMA an application to expand the label for Relvar Ellipta fluticasone furoate/vilenterol (GW685698/GW64244) to treat patients whose asthma is already adequately controlled on an inhaled...
21:43 , Aug 2, 2017 |  BC Extra  |  Financial News

Innoviva prices $175M notes offering

Innoviva Inc. (NASDAQ:INVA) raised $175 million through the sale of 2.5% senior convertible notes due 2025 in a private placement. The unsecured notes initially convert at $17.26, a 25% premium to the company’s close of...