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Pfizer/BioNTech’s COVID-19 vaccine should ideally be given in two doses 21 to 28 days apart, but due to ongoing shortages, an interval of up to 42 days is acceptable, the World Health Organization (WHO) said Friday. Read More
The European Union has secured 200 million more doses of the Pfizer/BioNTech COVID-19 vaccine, with an option to buy 100 million additional doses, bringing the total number of potential doses contracted for to 600 million. Read More
The UK’s National Health Service (NHS) will begin treating adult COVID-19 patients in intensive care with Roche’s and Sanofi’s arthritis medications following positive trial results that showed the drugs were highly effective when given early enough. Read More
Multiple COVID-19 vaccine developers are expected to file for regulatory approval in the coming months as the global pandemic continues its relentless advance. Read More
The Center for Drug Evaluation and Research (CDER) is set to reorganize its Office of Generic Drugs (OGD) to help keep up with the high volume of generic drug applications. Read More
The UK has approved Moderna’s COVID-19 vaccine through a temporary authorization pathway, gaining a third option to add to approved vaccines from AstraZeneca/Oxford University and Pfizer/BioNTech. Read More
A study carried out by the University of Texas Medical Branch and Pfizer has found that the drugmaker’s COVID-19 vaccine still protects against a viral mutation that’s raised concerns around the world, though more research is needed. Read More
Ascent Pharmaceuticals, a drug manufacturer in Central Islip, New York, drew a Form 483 after the FDA observed deficiencies at its facility, including a failure to check the effectiveness of corrective and preventive actions (CAPAs). Read More
Bristol Myers Squibb has withdrawn the U.S. indication for its blockbuster drug Opdivo (nivolumab) for treatment of small cell lung cancer, following disappointing clinical trial results. Read More
A federal appeals court ruling last year against Teva Pharmaceuticals threatens other generic drugmakers, according to an amicus brief filed Dec. 22 by a roll call of professors of law, economics, business, health and medicine. Read More