Regulatory
This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
Stakeholders Hope Bill Will Create IRA Drug Negotiation Parity Between Biologics and Small Molecules
Congressional legislation seeks to “equalize” the negotiating period between biologics and small molecules under the Inflation Reduction Act’s Drug Price Negotiation Program.
The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.
Amid the dual crises of worsening medicine quality and growing drug shortages, the FDA plans to increase inspections of Indian manufacturing facilities this year, Reuters reported Tuesday.
The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
The FDA’s target decision date is June 27, 2024, the companies announced Friday. Sanofi and Regeneron are looking to expand blockbuster Dupixent into chronic obstructive pulmonary disease.
The litigation alleges the regulator allowed its competitor Liquidia to skirt FDA precedents by amending an already pending NDA to add a PH-ILD indication instead of filing a new application.
With over 20% of people born between 1997 and 2003 identifying as a sexual and gender minority, moderated panels at SCOPE 2024 discuss the need to engage this community in clinical trials.
PRESS RELEASES