The specialty pharma makes its first acquisition of the New Year, tucking in gastrointestinal and cystic fibrosis franchises, which bolster its current therapeutic area offerings.
In-line with its multi-product strategy, Forest Laboratories Inc. announced its intentions to acquire privately held Aptalis Holdings Inc. on Jan. 8.
The $2.9 billion deal will delay new CEO Brent Saunders’ plans for a share repurchase program, but will help bolster...
The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.
The CDC’s current shared clinical decision-making recommendation for vaccinating healthy children age six months and older should trigger full coverage under the Affordable Care Act, but is not always happening at pharmacies and doctors’ offices, an Epstein Becker attorney said.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
