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The FDA has announced that it is working on guidance for states and for compounders on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.” Read More
Significantly more hospitalized COVID-19 patients aged 70 and up were alive and free of respiratory failure after treatment with GlaxoSmithKline’s (GSK) investigational monoclonal antibody otilimab in a phase 2 clinical trial, the company said Thursday. Read More
As Teva Pharmaceuticals tries to convince the full U.S. Court of Appeals for the Federal Circuit to reconsider its earlier judgment that it has to pay $235.5 million in damages to GlaxoSmithKline (GSK) for patent infringement, oral arguments this week left it unclear whether the final decision will be any different. Read More
President Biden signed an executive order Wednesday mandating a review of the U.S. supply chain for critical goods, including materials needed for manufacturing COVID-19 products — fulfilling a promise he made on the campaign trail. Read More
Senate hearings for HHS Secretary nominee Xavier Becerra, California’s attorney general, concluded Wednesday in the Senate Finance Committee, where Becerra was questioned by senators — and at times heatedly by Republican lawmakers — on a range of healthcare issues including drug pricing, drug shortages and intellectual property protections. Read More
The FDA has published a briefing document ahead of Friday’s advisory panel meeting showing that agency staff have found the promising, single-shot Johnson & Johnson COVID-19 vaccine safe and effective enough for Emergency Use Authorization (EUA). Read More
The World Health Organization (WHO) this week announced a vaccine injury compensation plan for the 92 low- and middle-income countries that are getting COVID-19 vaccines through its COVAX initiative. Read More
COVID-19 vaccine makers appearing yesterday before a U.S. House subcommittee pledged to lawmakers they would meet — and in some cases accelerate — their vaccine supply commitments, as the federal government and states clamor for more doses one year into the pandemic. Read More
The FDA’s Office of Clinical Pharmacology’s strike teams were directly involved in the agency’s efforts to battle the COVID-19 pandemic in 2020, according to an annual report it published Monday. Read More
The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending Emergency Use Authorizations (EUAs), noting that it doesn’t expect large-scale trials will be needed for the altered versions. Read More
The EC has secured an additional 300 million doses from Moderna and has inked a deal with Pfizer for a further 300 million doses of its vaccine co-developed with BioNTech. Read More