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The Office of Prescription Drug Promotion issued a warning letter to Shionogi, for omitting risks and material facts, for its head-lice lotion Ulesfia in a patient co-pay assistance voucher. Read More
British authorities say serious GMP deficiencies continue to plague Rusan Pharma’s Gujarat manufacturing facility, prompting them to reject all drugs from that site until it is compliant. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
J&J Unit Halts Development of Fulranumab; Returns Rights to Amgen Pfizer’s Bococizumab Shines in Second Phase 3 Lipid-Reducing Trial Taiho’s Colorectal Cancer Candidate Meets Primary Endpoints Regeneron/Sanofi’s Dupilumab Meets Primary Endpoints Read More
The FDA is clarifying that if an institutional review board is found to be noncompliant, the FDA may require the IRB to withhold approval of new clinical studies, stop enrolling new subjects in ongoing studies, and to terminate ongoing studies. Read More
The European Medicines Agency is pairing up with various governments’ policy review boards to streamline consultations with drug companies following a successful test run of the effort. Read More
The FDA has approved a supplemental application for abortion drug Mifeprex, updating the label to lower the dosage and extend the usage period to 70 days gestation from 49. Read More