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The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Read More
Gilead is defending a suite of patents for its profitable hepatitis C antivirals from challenges by a non-profit group petitioning the PTO’s Patent Trial and Appeal Board. Read More
The PTO’s Patent Trials and Appeals Board reversed course last week, granting inter partes review of a Herceptin patent that it previously refused, following challenges from Hospira. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
The FDA is looking for creative approaches to the opioid crisis, including new requirements for product packaging, as ways to reduce overall exposure to the painkillers. Read More
A federal judge dismissed more than 40 states’ claims against the parent company that manufactures Suboxone in a suit accusing it of suppressing generics. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
John Kapoor, founder and majority owner of Insys Therapeutics, was arrested and charged with bribery and fraud in the illegal distribution of a fentanyl spray, an opioid intended to treat pain in cancer patients. Read More