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An Indian drug manufacturer’s facility in Salcete, Goa drew a warning letter from the FDA for serious violations, including inadequate cleaning that left drug product residues inside manufacturing equipment. Read More
Drug industry trade groups PhRMA and BIO expressed a strong distaste for the Trump administration’s strategy for tackling high drug prices by importing Canadian medicines, arguing that the plan would fail to lower costs and could put patients at risk. Read More
Regeneron has identified hundreds of coronavirus antibodies for developing treatments for COVID-19 and hopes to start clinical trials by early summer. Read More
The first U.S. clinical trial for a coronavirus vaccine got under way yesterday — a phase 1 trial of Moderna’s mRNA-1273 in collaboration with the National Institutes of Health. Read More
The FDA hit Blaine Labs with a lengthy Form 483 for a host of violations at its Santa Fe Springs, CA, facility, including repeated quality unit failures. Read More
The FDA published a final guidance over the weekend on compounding alcohol-based hand sanitizers and said the agency will not take regulatory action against outsourcing facilities for regulatory violations for such products provided they include certain ingredients. Read More
Eagle Pharmaceuticals prevailed in an appeals court ruling that the FDA can grant orphan drug exclusivity to multiple drugs for the same rare disease. Read More