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Pfizer’s novel breast cancer drug Ibrance shows reasonable evidence of clinical benefit to warrant marketing it ahead of a Phase III study, the FDA said in granting accelerated approval Tuesday. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
The FDA is creating a simple, one-step process for physicians to gain access to experimental drugs for patients facing terminal, untreatable conditions. Read More
Colorado lawmakers have introduced a biosimilar substitution bill that closely mirrors at least one aspect of compromise language unveiled by industry leaders in December — elimination of prescriber notification in favor of entering a switch into an electronic database. Read More
Actavis will become the UK’s largest generics supplier once its roughly $461 million acquisition of Auden Mckenzie closes in the first quarter of this year. Read More
The average price of generic drugs rose 4.9 percent in 2014, while prices for their branded counterparts jumped 14.8 percent, a new study finds. Read More
With the launch of the FDA’s Office of Pharmaceutical Quality, all ANDA filers are now eligible for OPQ’s real-time communications program — the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More