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Massachusetts Attorney General Maura Healey is mulling legal action against Gilead Sciences over its sky-high prices for two hepatitis C medications, alleging that the company’s approach could violate the state’s antitrust laws. Read More
Would-be FDA Commissioner Robert Califf is facing another potential congressional hurdle, with Sen. Joe Manchin (D-W.Va.) saying he will filibuster the nominee, citing his strong ties to the pharmaceutical industry. Read More
The FDA is not in the business of regulating drug prices, CDER Director Janet Woodcock told a Senate committee yesterday, pushing back against criticism that the FDA should tackle rising drug prices. Read More
The Office of Manufacturing Quality’s 2015 annual report of warning letters blasted the drugmakers for disregarding previous inspection findings. Read More
One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to unnaturally extend the life of another medication. Read More
The UK’s reimbursement watchdog has given its blessing to five treatments — four for cancer and one for a lung disease — recommending they be funded by the National Health Service, while frowning on Lilly’s stomach cancer drug. Read More
Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More
The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted pharmacies in Pennsylvania, Massachusetts and Texas with Form 483s for inadequate sterilization practices. Read More