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Acadia Pharmaceuticals has filed three separate patent infringement suits in an attempt to block generic formulations of its only approved drug, Nuplazid (pimavanserin). Read More
The FDA is pushing off or rescheduling several advisory committee meetings this week — including one to consider what could become of the first over-the-counter (OTC) daily oral contraceptive in the U.S., Opill. Read More
Drug manufacturer and outsourcer Nephron SC failed to adequately investigate incidents of cross-contamination between its outsourced operations and its conventional manufacturing line, said the FDA in an especially lengthy and detailed warning letter that cautioned the company against sharing equipment between the two operations. Read More
The World Health Organization (WHO) should include drugs on its essential medicines list regardless of their cost, according to a group of researchers that advocates separating reviews of comparative effectiveness, safety and public health priority from consideration of the price of medicines and their cost-effectiveness. Read More
The Centers for Medicare and Medicaid Services (CMS) should require clinical trial participation of patients seeking coverage for many new drugs, particularly those that have accelerated approval. Read More
The Health Resources & Services Administration (HRSA) has warned Merck that it could get slapped with fines for refusing to grant 340B discounts to hospitals and clinics that participate in the program. Read More