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This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections. Read More
Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. Read More
Sanofi and development partner Regeneron are riding a regulatory roller coaster, with the EU giving Dupixent (duplilumab) a nod for chronic obstructive pulmonary disease (COPD) even as the FDA hedges, asking for more phase 3 data before granting the new indication. Read More
This month a dextromethorphan-based medicine flunked out for AD agitation, but agents for schizophrenia, mantle cell lymphoma and a clotting disorder did well, with some ready to make the regulatory leap. Read More
This week, the FDA issued a final rules related to the administrative destruction of medical devices that are thought to be counterfeit and announcing the termination of the Science Advisory Board to the National Center for Toxicological Research. Draft guidance was published on the platform technology designation program for drug development. Read More
This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
A February data breach at drug distributor Cencora has exposed the personal medical information of tens of thousands of patients, according to filings with numerous state attorneys general (AG) and the Securities and Exchange Commission (SEC). Read More
The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Read More
The final version of an International Council of Harmonisation (ICH) guideline that addresses evaluation of the drug-drug interaction (DDI) potential of an investigational drug is ready for adoption and a draft of a guideline on general principles for planning pharmacoepidemiological studies is ready for review. Read More