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The FDA’s adoption of the U.S. Pharmacopeia’s strict naming rules for drugs with salt-based active ingredients could lead to drug development delays, manufacturers warn. Read More
GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. Read More
The European Medicines Agency plans to move forward with a controversial clinical trial transparency plan, but with new added redaction features to remove trial data that could allow companies to steal commercially confidential information. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the application. Read More
A European Medicines Agency working group is recommending revisions to a guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins to account for differences between large complex and small, simple-structured proteins and other critical issues. Read More
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More
The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More