We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has updated its draft guidance for generic drugmakers on submitting controlled correspondence to the agency to include new review goals under the reauthorization of the Generic Drug User Fee Amendments (GDUFA III). Read More
The Institute for Clinical and Evidence Review (ICER) has tackled two disparate pricing regimens, suggesting that Pfizer cut the cost of its COVID-19 antiviral treatment Paxlovid by more than 80 percent and that ublituximab, TG Therapeutics’ potential blockbuster for multiple sclerosis (MS), wouldn’t be worth more than $55,081 per year if approved. Read More
A federal court has entered a consent decree against Qualgen — an Oklahoma outsourcing facility that has had multiple, previous run-ins with the FDA — prohibiting the compounder from distributing drugs across state lines. Read More
Many of the riders and amendments left on the cutting room floor in September when Congress passed user fee legislation have now been taken up again in a year-end omnibus spending package, a draft of which was released this week. Read More
HHS argues that the program would violate a criminal ban on any remuneration to induce purchase of any item “for which payment may be made in whole or in part under a federal health care program.” Read More
The Department of Health and Human Services (HHS) is pressing the Supreme Court to squash Pfizer’s appeal challenging the U.S. anti-kickback statute, filing a petition which lays out the department’s opposition to the patient assistance program Pfizer created to cover costs of its highest-priced drug. Read More
The agency observed that the facility’s environmental controls were inadequate to prevent cross-contamination of non-beta-lactam and beta-lactam drugs such as penicillin, raising the risk of allergic reactions in patients. Read More
The new recommendation extends the drug’s use to people with a forced vital capacity of more than 80 percent of expected normal lung capacity. Read More
Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder drug Hetlioz (tasimelteon). Read More