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As Congress continues to search for ways to rein in prescription drug costs, a new study published in JAMA this week showed that the price of new medicines has spiked from a median price of $2,115 per year in 2008 to $180,007 per year in 2021. Read More
With 392 ayes and 28 nays, the U.S. House of Representatives passed a package of legislation late Wednesday to reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device user fee programs. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic combination products if the generic product’s user interface is substantially different from the original product. Read More
Nephron Pharmaceuticals’ recall of approximately 2 million doses of 20 drug products last week followed a March 28 to April 20 inspection of the company’s outsourcing facility in West Columbia, S.C., that unveiled numerous quality lapses. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) sent Althera Pharmaceuticals an untitled letter for the company’s misleading promotional pamphlet for its cholesterol-lowering drug Roszet (rosuvastatin and ezetimibe). Read More
Roche subsidiary Genentech has filed a federal lawsuit claiming that Tanvex BioPharma’s not-yet-on-the-market biosimilar of Genentech’s blockbuster chemotherapy drug Herceptin infringes three patents. Read More
After getting deluged with more than 24,000 mostly negative comments about pharmacy benefit managers’ (PBM) effect on patients and payers, the U.S. Federal Trade Commission (FTC) has voted unanimously to investigate many of the PBMs. Read More
The settlement also prevents BMS from restricting Gilead Sciences from making or licensing a generic version of Evotaz (atazanavir and cobicistat), an HIV drug. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee voted almost unanimously yesterday for Emergency Use Authorization (EUA) of a two-dose primary series of the Novavax COVID-19 vaccine. Read More