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A proposed regulation issued by the FDA today would add two new parts to drug manufacturing regulations for medical gases focusing on labeling, current Good Manufacturing Practice (cGMP), certification and postmarket safety. Read More
The FDA issued a warning letter to Specialty Process Labs for significant deviations from current good manufacturing practices (cGMP) for active pharmaceutical ingredients (API), including failure to validate manufacturing processes and ensure uniform blends. Read More
Rocket Pharmaceuticals reported that its trial of a gene therapy targeted toward an aggressive and fatal rare disease in children had a 100 percent survival rate at one year — and the company expects to file for regulatory approval of the treatment in the first half of 2023. Read More
In a new draft guidance, the FDA presses drug manufacturers to develop risk management plans to further shore up the country’s drug supply chain. Read More
The European Medicines Agency’s (EMA) human medicines committee endorsed nine new drugs during its monthly meeting held from May 16 to 19, including LFB Biotechnologies’ coagulant therapy Cevenfacta (eptacog beta (activated)) for treating congenital hemophilia. Read More
Sens. Chuck Grassley (R-Iowa), Ron Wyden (D-Ore.) and Mike Braun (R-Ind.) are urging the Federal Trade Commission (FTC) to examine how pharmacy benefit managers (PBM) affect the cost of insulin products. Read More
Under the terms of the agreement, Cugene will receive an upfront payment of $48.5 million, plus additional payments for reaching developmental or regulatory milestones. Read More
A collection of 24 states is displaying its support to the Department of Health and Human Services (HHS) in its legal fight with several drugmakers over access to drugs discounted under the 340B Drug Discount program. Read More