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The FDA is explaining how generics firms can receive timely responses to their requests for information in a guidance that defines a new communications process known as “controlled correspondence.” Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
In an unusual case, Novo Nordisk agreed this week to pay $89,315 to Danish authorities to settle allegations it didn’t disclose the FDA’s rejection of two insulin products fast enough. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More
French drugmaker Sanofi is set to distribute large quantities of its new semisynthetic artemisinin malaria combination drug to six countries in which the mosquito-borne disease is endemic, a move that could address nearly one third of the global need. Read More
Generic versions of Depomed’s shingles drug Gralise are unlikely in the near future after a federal judge sided with the brand manufacturer’s patent infringement suit against a 2012 ANDA filed by Actavis. Read More
Gilead Sciences may continue marketing its blockbuster hepatitis C drug Sovaldi after winning a dispute with rival drugmaker Roche over rights to the expensive new therapy. Read More
The UK’s health cost-benefit agency has rejected Janssen’s prostate cancer drug Zytiga for use before chemotherapy, asserting it is unclear how much the therapy actually extends life, a decision the drugmaker plans to appeal. Read More
The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More