In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to revoke authorization of Ocaliva for treatment of primary biliary cholangitis — an autoimmune disease that destroys the liver’s bile ducts, a European Commission survey on electronic instructions for use for medical devices, a new pilot program for developers of orphan medical devices, and a thumbs down in the UK for Enhertu for treatment of HER2-low breast cancer by the National Health Service. Read More

Drastic changes in drug development mean quality management approaches are more critical than ever, with meaningful advancement hinging on cultural shifts, cross functional alignment and top-down approaches within organizations, as well as thoughtful, stakeholder-informed trial designs. Read More

This edition of Quick Notes features a CRL for Lykos Therapeutics NDA for midomafetamine for treating post-traumatic stress disorder and approvals for Amneal’s Crexont, Novartis’ Fabhalta and Citius Pharmaceuticals’ Lymphir. Read More

The FTC has submitted a comment supporting the FDA draft guidance on interchangeable biosimilar drugs saying that the recommendations in the guidance would increase patient access to lower-cost prescription medications. Read More

The FDA has finalized advice for generic drug sponsors on seeking meetings with the agency to discuss the impact of a new or revised product-specific guidance (PSG) on their ANDA development programs. Read More

This edition of Quick Notes features approvals for Adaptimmune’s Tecelra, Purdue Pharma’s Zurnai, Servier Pharmaceuticals’ Voranigo and Aurobindo’s Estradiol. Read More

Velocity Pharma’s lack of oversight of the quality of the eye drops its contract manufacturer — Kilitch Healthcare India Limited who received its own Warning Letter for the eye drops — has earned it an FDA Warning Letter. Read More

Omega Tech Labs received an FDA Warning Letter for inadequate procedures to prevent microorganisms in its combination product and failure to meet water quality standards in manufacturing following a Jan. 17-22 inspection. Read More

Novartis’ 2022 complaint against several generic drugmakers for allegedly infringing on a patent for its blockbuster heart failure drug Entresto (sacubitril/valsartan) was denied on Tuesday, but the judge gave the company a stay in the order to allow it to appeal in federal court. Read More

From a warning that the new pricing scheme doesn’t mean patients are protected from increased costs to another that the Inflation Reduction Act (IRA) pricing scheme will limit patients’ access to medicines now and in the future, big pharma has expressed its displeasure with the public unveiling of prices. Read More

The FDA is inviting comments, for consideration by WHO, concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight narcotic drugs. Read More

After a bumpy road to approval, the FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 66 pounds. Read More