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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
A former Eli Lilly employee is suing the drugmaker over allegations she was fired after identifying numerous production issues at Lilly’s Branchburg, N.J., plant, including in the manufacture of the company’s blockbuster, Trulicity. Read More
Johnson & Johnson (J&J) is pulling out of its COVID-19 vaccine supply contract with the troubled drug manufacturing plant, Emergent BioSolutions. Read More
The FDA issued a warning letter to Grimann, an over-the-counter (OTC) drug manufacturer located near Mexico City, for failure to comply with drug registration and listing requirements. Read More
Novartis confirmed Monday it was the victim of a cyberattack that ended in stolen data but maintained the hackers didn’t get away with any sensitive information. Read More
In a March 30 meeting, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 against recommending AMX0035 for patients with ALS. Read More