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HHS has published a subset of its semiannual rulemaking agenda for 2023, outlining those planned rules – including several from the FDA – that are likely to have a significant economic impact for some small entities.
Baudette, Minn.-based Ani Pharmaceuticals was hit with a six-observation Form 483 from the FDA that spotlights almost a year of ignoring customer complaints about products and not following its standard operating procedures (SOPs) for handling events that set off alarms in production.
ANDA applicants should submit a request for a PSG teleconference within 60 days after publication of a new or revised PSG so that the FDA can provide timely feedback, the agency said. Read More
The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection to treat patients with geographic atrophy secondary to age-related macular degeneration, a condition that is a leading cause of blindness. Read More
Theravance Biopharma and Viatris have alleged that multiple drugmakers infringed on their patent protections for Yupelri (revefenacin) — an inhalation solution used to treat chronic obstructive pulmonary disease (COPD) — by developing generic versions of the drug. Read More
The FDA has granted Accelerated Approval (AA) to Travere Therapeutics’ Filspari (sparsentan) to reduce proteinuria (high levels of protein in the urine) in adults at risk of rapid progression of the rare kidney disease primary endothelin-1 and angiotensin II (IgAN). Read More
TG Therapeutics would have to cut the price of its newly approved multiple sclerosis antibody Briumvi (ublituximab) by up to 84 percent to meet the same cost-effectiveness threshold as other monoclonal antibodies used to treat the disease, according to a report by the Institute for Clinical and Evidence Review (ICER). Read More