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The number of clinical trials that make it through to regulatory approval over the past decade is less than 8 percent, according to a new report on clinical success rates. Read More
The EU yesterday unveiled a plan to speed up regulatory approvals and manufacturing of vaccines against emerging strains of the SARS-CoV-2 virus that causes COVID-19. Read More
Acting FDA Commissioner Janet Woodcock rejected a proposal to put up a “firewall” between FDA staff involved in pre-submission interactions and staff working on post-submission drug and biologic reviews and decisions, defending the agency’s collaboration with sponsors as critical to the development process. Read More
Created by the prior administration to accelerate development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics, Operation Warp Speed (OWS) is an initiative in search of a new name, but it already has a new lineup of prominent individuals chosen by the Biden administration, including a new front man, Jeffrey Zients. Read More
The EU has struck new supply agreements with Moderna and Pfizer, boosting its total COVID-19 vaccine arsenal to up to 2.6 billion doses, enough to inoculate the bloc’s 446 million citizen many times over, but it is promising to share with “neighbors and partners.” Read More
Merck’s blockbuster oncology drug Keytruda has shown promising results against an advanced form of kidney cancer in a late-stage clinical trial. Read More
Bristol-Myers Squibb and Sanofi said they will appeal an $834 million judgment against them by a state court in Hawaii over the safety of their anti-blood clotting drug Plavix (clopidogrel). Read More
Amgen has failed to convince the U.S. Court of Appeals for the Federal Circuit that Sanofi and Regeneron Pharmaceuticals should be made to pay for infringing its patents on its cholesterol drug Repatha (evolocumab). Read More
Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks, according to its latest annual report on Drug Safety Priorities. Read More