FDA On Track With PDUFA VII Goals Centered on DHT-Related Submissions
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…
Cell and Gene Therapy Project Orbis Still Just a Concept, Says FDA
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…
One in 10 Drugs Approved by FDA Did Not Achieve All Trial Endpoints, Researchers Say
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…
Biocon and Viatris Draw Complete Response Letter for Bevacizumab BLA
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.…
CMS Guidance Requires Drugmakers to Pay Up if Price Hikes Exceed Inflation Rate
Newly released federal guidance details how the federal government will punish drug companies that hike prices faster than the rate of inflation for some prescription Medicare medicines — a move…
Bipartisan Bills to Limit Drug Prices Clear Senate Judiciary Committee
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…
Sun Pharmaceuticals Recalls Blood Pressure Drug for Impurity
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…
Form 483 Finds Multiple Sterilization Issues in Pharmacy Plus Inspection
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…
EMA to Review Pseudoephedrine Drugs After Reports of Brain Vasoconstriction
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…
Phathom Receives Two CRLs Over Nitrosamine Impurities
The FDA has issued two complete response letters (CRL) to Phathom Pharmaceuticals, one for a new drug application (NDA) for its acid suppressant vonoprazan for treating erosive esophagitis and another…
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