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Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized this week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Australian regulators are seeking industry input on the pilot phase of a new system that will let drugmakers submit applications electronically, as the country prepares to fully adopt the software next year. Read More
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