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The FDA released a draft guidance Thursday recommending ways to demonstrate if new drugs or drug uses are effective for certain low-prevalence rare diseases caused by single enzyme defects. Read More
An FDA advisory committee agreed Thursday that 60 Degrees Pharmaceuticals proved the safety and efficacy of its NDA for tafenoquine indicated for the prevention of malaria in adults. Read More
The FDA on Thursday issued final guidance closing a loophole under which drug sponsors could avoid their obligation to study drugs in pediatric indications. Read More
The bill would bar insurers or pharmacy benefit managers from restricting a pharmacy’s ability to provide drug price information to a plan enrollee. Read More
The agency cautioned that “the acceptability of these surrogate endpoints for use in a particular drug or biologic development program will be determined on a case-by-case basis.” Read More
Pay-for-delay deals have led to massive lawsuits, such as the class-action suits against Endo, Watson and Teikoku over a pay-for-delay arrangement for a generic version of Endo’s Lidoderm pain patch. Read More