The FDA has approved Newron Pharmaceuticals' Xadago, or safinamide, as an add-on drug for patients with Parkinson's disease. Xadago is indicated for patients who already take levodopa/carbidopa but experience "off" episodes in which the treatment is not effective.
A study that found Amgen's PCSK9 inhibitor Repatha prevented heart attacks and strokes but not cardiovascular-related deaths could lead to increased use of the drug, which carries a $14,523-a-year list price. "Getting the patients approved had been difficult, and because there was no endpoint data many practitioners didn't push very hard," said Express Scripts Chief Medical Officer Dr. Steven Miller.
The FDA has again denied AstraZeneca and ZS Pharma's application for ZS-9, or sodium zirconium cyclosilicate, intended to treat patients with high potassium levels in the blood. The complete response letter issued by the FDA cited manufacturing concerns from a facility inspection that the companies must address before they can resubmit.
A midstage clinical trial of Aevi Genomic Medicine's AEVI-001, assessed as a treatment for adolescent patients with metabotropic glutamate receptor mutation-positive attention-deficit/hyperactivity disorder, failed to meet its primary endpoint. The lead candidate did not achieve a lower ADHD Rating Scale than a placebo.
Implementation of the final rule outlining when tobacco products will be regulated as medical devices has been postponed by the FDA until March 2018 in response to a petition from biopharmaceutical groups, including BIO and PhRMA, that the FDA's final rule changes the definition of "intended use" by introducing the concept of "totality of evidence," which would also affect the FDA's definition of intended use for drugs and medical devices. The groups have asked that the agency revert to the language used in the draft rule, and the FDA agreed to hold off on implementation while gathering industry feedback.
The total fees charged by the FDA to review and approve new drugs and medical devices would more than double to more than $2 billion under the 2018 budget proposed by the Trump administration. AdvaMed is seeking more details on the budget before it can evaluate the proposal's effect on FDA appropriations or user fee funds, President and CEO Scott Whitaker said.
Following a nationwide referendum on June 23, 2016, the United Kingdom is about to begin its formal withdrawal from the EU (known as Brexit) by triggering Article 50 of The Treaty on European Union. The final terms of the UK's new relationship with the EU following its withdrawal are yet to be decided. With uncertainty continuing, businesses operating in or trading with companies based in the UK and EU are keen to learn how they may be affected. Read more.
Matt Chmel, the leader of Aon Risk Solutions' professional risk solutions team, said full limits for ransomware-attack coverage may be available even though such coverage often faces sublimits in cyberinsurance policies. Each of the 67 cyberinsurers uses "different language and verbiage," so reviewing policy language with a broker is crucial, Chmel said. Read more.
To different minds, the same world is a hell, and a heaven.
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