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Sponsors of randomized clinical trials (RCT) using real-world data (RWD) to support regulatory decisions in the UK should show they have applied the same data validity and integrity standards used for conventional trial sources, according to a draft guidance the Medicines and Healthcare products Regulatory Agency (MHRA) published in late October. Read More
Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., has been sent a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Read More
Over the counter (OTC) drugmaker Cosmax USA may have distributed batches of its product contaminated with dangerous bacteria, the FDA said in a warning letter to the Ridgefield Park, N.J. company. Read More
Novavax announced Wednesday that it has reached an agreement with Australia that will see the company supply 40 million doses of its COVID-19 vaccine candidate for the country. Read More
UK Vaccine Taskforce Chairwoman Kate Bingham revealed Wednesday that the country will have millions fewer doses of AstraZeneca’s vaccine candidate available by the end of the year than previously anticipated. Read More
Novartis has announced that effective Nov. 16, it will remove discounts for hospitals enrolled in the 340B Drug Pricing Program for products dispensed at pharmacies that are more than 40 miles from a hospital’s main facility. Read More
In an unusual move, the FDA has removed an advisory committee member temporarily, just days before a critical vote on an investigational treatment for Alzheimer’s disease. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. Read More