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Drugmakers in the EU will pay slightly lower fees starting this month, under an annual adjustment that reflects the inflation rate for the previous year Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
A federal judge ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by April 13, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India. Read More
The Centers for Medicare & Medicaid Services has announced that it plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More
The FDA is offering a grant of up to $1 million to turn large amounts of electronic health record data into usable figures highlighting postmarket risks of various drugs. The goal is for the agency to be able to perform continuous risk/benefit assessments of drugs after they hit the market. Read More
The Medicines Company’s Kengreal may be on the road to approval, with FDA reviewers backing its use as a post-angioplasty anticlotting agent one year after the agency rejected the drug for this and another indication. Read More
Japan’s drug authority will grant conditional approval to human embryonic and somatic stem cell therapies based on limited clinical data, under a new approval pathway meant to speed patient access to innovative products. Read More