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...
23:12 , Oct 25, 2017 |  BC Extra  |  Company News

GSK's interest in expanding consumer healthcare business concerns investors

In its 3Q17 earnings call, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reiterated its strategy to expand its consumer healthcare business, sparking investor concerns of a possible dividend cut. GSK lost $2.29 to $38.19 in New York, and...
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...
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
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...
19:53 , May 12, 2017 |  BC Week In Review  |  Clinical News

Relvar Ellipta meets primary in Salford real-world asthma outcomes study

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said Relvar Ellipta fluticasone furoate/vilanterol (GW685698/GW64244) met the primary endpoint in the open-label, U.K. Phase III Salford Lung Study in 4,233 patients with asthma. Specifically, 71% of...
01:11 , May 6, 2017 |  BC Extra  |  Clinical News

Salford study reveals real-world asthma outcomes

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said Relvar Ellipta fluticasone furoate/vilanterol met the primary endpoint in the Phase III Salford Lung Study to treat asthma. The study is GSK’s second real-world outcomes trial...