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Although specialty drugs make up only a small fraction of the total retail prescriptions filled in the U.S., they accounted for 37.7 percent of retail and mail-order prescription net spending from 2016 to 2017 even with rebates factored in, a new analysis has found. Read More
The FDA is expected to support Biogen’s potential blockbuster Alzheimer’s drug aducanumab today in a crucial advisory committee meeting today. Read More
The FDA issued warning letters to four topical drug manufacturers in Mexico for using unapproved ingredients in their hand sanitizer products. Read More
Merck plans to acquire cancer drug developer VelosBio for $2.75 Billion, expanding its presence in antibody-drug conjugates (ADCs), a new class of biological drugs. Read More
In an investor call yesterday, Regeneron CEO Leonard Schleifer said he hoped for an early decision by the FDA on an Emergency Use Authorization (EUA) of the company’s COVID-19 antibody cocktail treatment REGN-COV2. Read More
The bitterly fought U.S. presidential battle may drag on for some time if the results are contested, but should Democrat Joe Biden emerge victorious, his administration is expected to take a more hands-off approach to the FDA on COVID-19 vaccines and therapeutics. Read More
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they have applied the same data validity and integrity standards used for conventional trial sources, according to a draft guidance the Medicines and Healthcare products Regulatory Agency (MHRA) published in late October.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