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Eli Lilly has teamed up with health insurer Anthem to draft a pair of position papers asking federal regulators and legislators to fundamentally rethink the way manufacturers and payers interact. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
The FDA on Thursday blessed Merck’s Zepatier, a combination of elbasvir and grazoprevir, with or without ribavirin, for treatment of chronic hepatitis C virus genotypes 1 and 4. Read More
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
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
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