BioCentury | May 1, 2020
Regulation

CHMP backs new therapy for 1L AML, triple combos for asthma

EMA’s CHMP this month recommended four new medicines for approval, including a new front-line therapy for AML and triple combination therapies for asthma. The agency recommended approval for Daurismo glasdegib from Pfizer Inc. (NYSE:PFE) to...
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

BioMarin's hemophilia gene therapy gets Priority Review  BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) could become the first company to have a hemophilia gene therapy approved in the U.S. FDA accepted and granted Priority Review to a BLA...
BioCentury | Aug 2, 2019
Regulation

Digital platforms that could make real-world data usable

As real-world data grows in importance so does the need to stitch together disparate data sources in a way that makes the information usable. A recent meeting co-hosted by FDA and the Duke Margolis Center...
BC Extra | May 2, 2019
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...
BioCentury | Apr 6, 2019
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...
BC Extra | Oct 31, 2018
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...
BioCentury | Apr 27, 2018
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...
BioCentury | Oct 20, 2017
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...
BC Week In Review | Sep 22, 2017
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...
BC Week In Review | Sep 22, 2017
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...
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