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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
The FDA on Wednesday published a list for drug sponsors of surrogate endpoints they may consider in trials to support drug approvals or licensures. Read More
Two drugmakers targeted in a lawsuit over Tennessee’s opioid epidemic filed a third-party complaint against online “black market” drug distributors, alleging they’re responsible for the state’s opioid crisis. Read More
An advisory panel Wednesday recommended that the FDA collect more data before signing off on use of GlaxoSmithKline’s asthma drug mepolizumab for treating chronic obstructive pulmonary disease (COPD). Read More
The Senate Health Committee unanimously approved a bipartisan bill on Wednesday that would outlaw “gag clauses” that prevent pharmacists from telling patients a drug would be cheaper if they paid out of pocket instead of using their insurance. Read More