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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
The FDA has issued two new guidances on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer. Read More
Eli Lilly announced positive results from a phase 3 clinical trial evaluating the safety and efficacy of tirzepatide injection in adults with heart failure with preserved ejection fraction and obesity. Read More
The FDA has provided a case study of how CDER used machine learning to identify a suitable patient population for a COVID-19 treatment that was approved under the emergency use authorization (EUA). Read More
The CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP) is inviting pharmaceutical companies interested in participating to submit a site visit proposal. Read More
CDER’s Office of Surveillance and Epidemiology (OSE) made significantly more use of AI and machine learning tools in 2023 to reduce the demands of manual reviews, according to OSE’s latest annual report. Read More