Archive for November 2021
Bharat Biotech’s Covaxin Was 50 Percent Effective in Real-World Study
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
Read MoreEurope Concedes Intellectual Property Waivers Can Help Fight COVID-19
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 Trade Organization (WTO) negotiations, it is now backing them. Source: Drug Industry Daily
Read MoreMore Cities, Counties May Sue Pharmacy Companies Over Opioids Now That Two Ohio Counties Have Prevailed
Will more city and county governments now begin suing pharmacy companies over their role in the opioid crisis? Source: Drug Industry Daily
Read MoreBiden Administration Misses Key Deadline, Likely Pushing Califf Nomination Vote into 2022
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 role of Commissioner of the FDA before the end of 2021. Source: Drug Industry Daily
Read MoreGSK to License Arrowhead’s RNAi Therapeutic for Liver Disease in $1 Billion Deal
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 is potentially worth more than $1 billion. Source: Drug Industry Daily
Read MoreJapanese Sterile Drugmaker Toyobo Hit with 11-Observation 483
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 Industry Daily
Read MoreNew Emails Suggest Former FDA Commissioner Hahn Intentionally Made False Claim about Convalescent Plasma
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 of their efficacy? Source: Drug Industry Daily
Read MoreAbout 40 Percent of Aduhelm Patients Experienced Brain Swelling, Bleeds
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 dose. Source: Drug Industry Daily
Read MoreFDA Completes More Inspections than Anticipated in Fiscal 2021
The FDA issued an update yesterday on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to new approaches introduced during the pandemic. Source: Drug Industry Daily
Read MorePfizer Says its COVID-19 Vaccine Is 100 Percent Effective in Kids 12-15
The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported. Source: Drug Industry Daily
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