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In an about face, a UK healthcare cost watchdog is now recommending coverage of Celgene’s blockbuster cancer drug Revlimid, persuaded by the drugmaker’s proposed payment scheme. Read More
Ferring Pharmaceuticals has won its appeal of a UK cost effectiveness watchdog’s final recommendation that would have drastically reduced the intended patient population for its cancer treatment Firmagon. Read More
Sanofi unit Genzyme says it plans to launch its new Gaucher disease therapy Cerdelga in the U.S. next month after receiving FDA approval late Tuesday. Read More
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