While new COVID-19 variant Omicron is now charging across Asia and Europe, causing cancellations and travel bans, vaccine makers Moderna, Pfizer/BioNTech and Johnson & Johnson (J&J) each say they are…
India-based Bharat Biotech’s COVID-19 vaccine, Covaxin (BBV152), was just 50 percent effective in preventing infections among hospital employees in India who received the recommended two doses. Source: Drug Industry Daily
The European Union appears to have reversed its previous stance on intellectual property (IP) waivers for COVID-19 vaccines and therapeutics. Instead of threatening to veto IP waivers in ongoing World…
Will more city and county governments now begin suing pharmacy companies over their role in the opioid crisis? Source: Drug Industry Daily
Due to the Biden Administration’s failure to furnish Congress with papers by the deadline, Robert Califf is unlikely to get a full Senate floor vote on his nomination for the…
GlaxoSmithKline (GSK) has forged an exclusive license agreement with Arrowhead Pharmaceuticals to develop and commercialize ARO-HSD, Arrowhead’s investigational RNA interference (RNAi) therapeutic currently in a phase 1/2 trial. The deal…
Dirt floating in so-called sterile vials and other serious quality lapses led the FDA to hit sterile drug manufacturer Toyobo of Otsu, Japan, with an 11-observation Form 483. Source: Drug…
Did former FDA Commissioner Stephen Hahn cave to political pressure from the Trump Administration in authorizing hydroxychloroquine and convalescent plasma as treatments for COVID-19 even though there was scant evidence…
More than 40 percent of patients in pivotal phase 3 trials of Aduhelm (aducanumab), Biogen’s FDA-approved Alzheimer’s treatment, experienced either brain swelling or microhemorrhages associated with the now-approved 10 mg/kg…
Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the institutional review board (IRB) at Hennepin County Medical Center (HCMC) over investigational…