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“A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure,” the ruling states. Read More
A federal appeals court has backed up the FDA’s decision to block prescription generics of Bayer’s MiraLax after the branded version switched to over-the-counter status. Read More
HHS invoked its emergency authority to bypass Office of Management and Budget review to quickly roll out a survey to assess prescribing trends for buprenorphine. Read More
A proposed class action suit alleging that multiple pharmacy benefit managers are responsible for Mylan’s price hike of EpiPen will move forward, after a Minnesota federal judge denied requests to have the case thrown out. Read More
Sen. Claire McCaskill (D-Mo.) released a third report on drug pricing claiming her constituents pay up to 600 percent more than citizens of other countries for branded Medicare Part D drugs. Read More
Eagle argued in favor of broad exclusivity for its product, writing that it should apply to any applications containing bendamustine for the indications protected by the orphan exclusivity. Read More