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The FDA has issued a complete response letter (CRL) to Biocon and Viatris over their biologics license application (BLA) for bevacizumab, a proposed biosimilar of Roche’s blockbuster cancer drug Avastin. Read More
Ten percent of new drug approvals in the U.S. from 2018 to 2021 were based on pivotal studies that failed to meet at least one primary endpoint, according to a new report that concludes the FDA needs to be more transparent about its approval decisions. Read More
The concept of a multi-national concurrent review process for cell and gene therapies based on the current international partnership Project Orbis is just that — a concept with no immediate timeline for launching such an effort, according to a top FDA official. Read More
By the end of March, the Center for Drug Evaluation and Research (CDER)’s Office of Strategic Programs (OSP) will have met its first Prescription Drug User Fee Act (PDUFA) VII goal: enhancing internal systems review of digital health technology (DHT)-related submissions — enabling the agency to better receive and digest submissions that contain reams of data from, for example, wearable devices. Read More
An October FDA inspection of Hattiesburg, Miss.-based Pharmacy Plus (also known as Vital Care Compounder) found multiple issues with product sterilization, including problems in the ISO 5 classified aseptic processing area. Read More
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will review data on medicines containing pseudoephedrine hydrochloride following reports that the decongestant drugs are associated with two potentially serious vasoconstrictive brain conditions. Read More
Indian generics company Sun Pharmaceuticals is facing yet another quality control issue as it recalls several lots of its blood pressure medication diltiazem hydrochloride in the U.S., after samples failed FDA impurity and dissolution testing. Read More
Two bipartisan bills reintroduced in the new Congress by Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) that seek to curtail prescription drugs costs have successfully passed the Senate Judiciary Committee, paving the way for their consideration by the full chamber. Read More