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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
Merck’s COVID-19 pill Lagevrio (molnupiravir) not only reduced the risk of hospitalization or death in patients with mild-to-moderate COVID-19 by 32.1 percent, it also reduced the chance of needing acute care visits for weeks after treatment ended, researchers reported in the Annals of Internal Medicine. 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