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The European Commission granted a conditional marketing authorization on Friday for AstraZeneca’s (AZ) COVID-19 vaccine just hours after an expert panel gave its blessing to the low-cost vaccine that can be shipped and held at normal refrigerator temperatures — as the bloc intensified efforts to secure delivery of initial doses and some EU members questioned the vaccine’s effectiveness for older individuals. Read More
The Government Accountability Office (GAO) has issued its fifth report on the federal government’s efforts to combat the COVID-19 pandemic, citing concerns that critical issues have still not been addressed, including the need for a “clear and comprehensive vaccine distribution plan.” 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
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
The EU’s dispute with AstraZeneca (AZ) over the supply of the company’s vaccine intensified yesterday as European Commission (EC) officials met with the company and called on it to release the full terms of its European supply contract. Read More
Immuno-oncology and precision medicine will continue to lead emerging trends in the biopharmaceutical industry this year, the market research firm GlobalData reported. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number of generic drug-related topics. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) piled onto the industry challenge to the federal 340B drug discount program, filing a complaint Friday in the U.S. District Court for the District of Maryland against a regulation promulgated by the Trump administration. Read More