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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
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to guidance released earlier this month that sets specific timelines for every step of the dispute resolution process. 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
Generics makers may soon have a new way to challenge first-filer marketing exclusivity held by their rivals under certain circumstances after a federal appeals court reinstated a lawsuit from Apotex. 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
New hepatitis C treatments were the biggest driver of specialty drug spending growth in the U.S. last year, helping to push total outlays on prescription drugs to $374 billion, the IMS Health Institute for Healthcare Informatics reports. Read More