The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
With COVID-19 cases once again surging across the globe and several countries considering targeted lockdowns, vaccines remain the best hope of restoring a sense of normalcy amidst the pandemic. For vaccines to work though, people must have enough confidence in the efficacy and safety that they’re willing to get vaccinated when the vaccines become available. That’s why the emergency use authorization (EUA) guidance the FDA released Oct. 6 for COVID-19 vaccines is so important.
In a valuable new deal for Cstone Pharmaceuticals Co. Ltd., Pfizer Inc. is taking a 9.9% stake in the company and licensing exclusive rights to commercialize its lead asset, the anti-PD-L1 antibody sugemalimab, in mainland China.
Both Solid Biosciences Inc. and Pfizer Inc. got lifts to their Duchenne muscular dystrophy (DMD) programs from the FDA as the agency released a clinical hold and awarded a fast track designation to their respective adeno-associated viral (AAV) programs.
In a valuable new deal for Cstone Pharmaceuticals Co. Ltd., Pfizer Inc. is taking a 9.9% stake in the company and licensing exclusive rights to commercialize its lead asset, the anti-PD-L1 antibody sugemalimab, in mainland China.
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.
LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.