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Novartis CEO Vas Narasimhan said the company is looking to help other companies scale up production of COVID-19 vaccines and treatments and is currently in talks with “key players.” Read More
Novavax has announced interim results from a phase 3 UK trial that showed its COVID-19 vaccine candidate, NVX-CoV2373, demonstrated 89.3 percent efficacy but faltered in a separate study that evaluated the vaccine for the South Africa variant. Read More
More than two dozen patient and consumer advocacy groups are calling on the Biden administration to drop acting FDA Commissioner Janet Woodcock as a potential nominee for commissioner because of her role in the agency’s past handling of the nation’s opioid epidemic. Read More
Researchers from Pfizer and the University of Texas Medical Branch have found that the Pfizer/BioNTech COVID-19 vaccine was still able to effectively neutralize key mutations in the highly contagious UK and South African coronavirus strains, offering hope that the prominent vaccine won’t need to be readjusted at this point. Read More
Yuyao YiJia Daily Chemical, an over-the-counter drug manufacturer in Ningbo, China, drew a warning letter from the FDA for not adequately testing its products, their active ingredients and the raw materials used to manufacture them. Read More
The Federal Trade Commission (FTC) has filed a lawsuit against Endo Pharmaceuticals and Impax Laboratories alleging that a 2017 agreement between the companies violated the antitrust laws by eliminating competition in the market for an extended release opioid, oxymorphone ER. Read More
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
The World Health Organization (WHO) is recommending that pregnant women should not use Moderna’s vaccine, except for those deemed to be at high risk of infection. Read More
Johnson & Johnson (J&J) said it plans to release late-stage trial data for its COVID-19 vaccine candidate next week — a single-dose shot that could help the Biden administration exceed its goal of 100 million vaccinations in 100 days. Read More