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Pharmacy benefits managers breathed a sigh of relief last week when the Trump administration backed off proposals that would set Medicare drug prices based on the discounts offered by the benefits managers. Read More
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended limiting prescriptions of Xeljanz and cancelling fenspiride’s marketing authorization, citing safety concerns. Read More
Health Canada is increasing fees for drug sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Read More
The agency says it will work hard to keep the minutes confined to “a summary of general concepts that were discussed, while excluding information” that might reveal a company’s important secrets. Read More
Akcea received a complete response letter from the FDA last year, citing concerns about the drug causing dangerous dips in patients’ platelet counts. Read More
The FDA is willing to be flexible because the regulations outlining the content of an ANDA “do not describe the type or amount of information that an ANDA applicant must submit to demonstrate” that the active ingredient in the proposed generic drug product is the same as the active ingredient in the reference drug. Read More
The Association for Accessible Medicines said it “applauds” the final guidance document, “particularly its streamlined data and study design requirements… Read More
The FDA said it plans to reach out to drug manufacturers that turn down oncologists’ requests for single patient investigational new drugs (INDs) through a pilot program designed to restructure applications for expanded access. Read More
The House on Thursday passed a seven-bill package by 234-183 votes, including three bills proponents say will reform the drug patent system, speed cheaper generics to market and ultimately lower drug prices. Read More
The Centers for Medicare and Medicaid Services has backed off a proposed rule that would have used the lowest possible payment to a pharmacy as the baseline price for Medicare. Read More
Gilead CEO Daniel O’Day on Thursday defended his company’s handling of its blockbuster HIV prevention pill Truvada before hostile House Democrats. Read More