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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee declared the chemotherapy drug docetaxel safe to use after it concluded that there is no evidence of changes in the known risk of intestinal inflammation after treatment. Read More
The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More
The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Read More
The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees. Read More
The Supreme Court of Canada struck down the “promise doctrine” used in the evaluation of a patent’s validity — a victory for the pharmaceutical industry, which said its use has led to the cancellation of over two dozen drug patents in the country over the past ten years. Read More
The Supreme Court’s ruling this week on a patent dispute over printer toner cartridges could have wider effects on the pharmaceutical industry, international sales and product reimportation. Read More
China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
An FDA advisory committee voted unanimously Wednesday in favor of the risk-benefit profile for Novartis’ BLA for an innovative new cancer therapy. Read More