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An uptick in drug prices contributed to an increase of 8.4 percent in retail prescription drug spending in 2022, according to a recent CMS report. Read More
The FDA has announced a new Genetic Metabolic Diseases Advisory Committee (GeMDAC) to help the agency explore the complex issues related to genetic metabolic disease drug development. Read More
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More
According to a poll released this week by the Biotechnology Innovation Organization (BIO), U.S. voters would support a bill introduced in September to fix a provision in the Inflation Reduction Act (IRA) that disincentivizes drug companies from discovering multiple rare disease applications for the same medicine. Read More
Novartis and Lupin are seeking additional clarity on thresholds of unspecified impurities in topical ophthalmic drug products, according to comments on the FDA’s October draft guidance on the subject. Read More
Under a new program, described in a draft guidance issued Tuesday, the FDA will expedite development and assessment of applications, including supplements, for drugs that are manufactured using a designated advanced manufacturing technology (AMT). Read More
Actions and future plans by the Biden administration to impose drug price controls could prove disastrous for U.S. clinical trials and medical innovation overall, the U.S. Chamber of Commerce (CoC) claims in a new report. Read More
Comments from AstraZeneca, Pfizer, Johnson & Johnson and Certara on the FDA’s draft guidance on developing peptide drugs focused on ways to categorize peptides and the potential for the drugs to cause an immune response. Read More
The FTC announced on Monday its intention to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics’ therapy in development for treatment of Pompe disease and hours later Sanofi announced that it was cancelling the deal. Read More