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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Bristol Myers Squibb has withdrawn the U.S. indication for its blockbuster drug Opdivo (nivolumab) for treatment of small cell lung cancer, following disappointing clinical trial results.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
India’s Bharat Biotech has finalized enrollment for a phase 3 trial of its COVID-19 vaccine, Covaxin, which Indian regulators approved Jan. 3 for emergency use. Read More
A small randomized trial in Argentina has found that the early use of convalescent plasma in COVID-19-infected adults helped to reduce progression to severe disease. Read More
German vaccine developer CureVac has secured a deal with Bayer to help gain regulatory approvals worldwide for its messenger RNA-based COVID-19 vaccine candidate, CVnCoV. Read More