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While the FDA has signaled concerns that drugs like Ozempic and Wegovy (semaglutide) come with an increased risk of suicidal ideation, a new study in the journal Nature says they don’t. Read More
How the FDA handles internal scientific disagreements and whether scientists have faced retaliation for expressing differing scientific views is the subject of a letter sent by the House Energy and Commerce Committee to the FDA. Read More
Just days after the FTC won a temporary injunction to halt IQVIA’s proposed acquisition of Propel Media’s DeepIntent healthcare advertising business, the companies have mutually agreed to abandon the proposed merger. Read More
The FDA has approved Florida’s plan to import drugs from Canada, making it the first state permitted to do so, after submitting its plan to the FDA in 2020. Read More
In an effort to stay dominant in the burgeoning obesity market and expand in the liver disease space, Novo Nordisk has forged two new research partnerships, each potentially worth up to $532 million. Read More
In a move that sidesteps pharmacy benefit managers, Eli Lilly has launched a direct-to-consumer marketing program that will provide several of the company’s medicines for obesity, migraine, and diabetes at steeply discounted prices, and without the need for a face-to-face doctor visit. Read More
The FDA has issued a warning to patients and health care providers to not use the Synovo Total Hip System including resurfacing implants, manufactured by Synovo Production after 2019, because components of the system have been modified from the cleared device and the safety and effectiveness has not been established. Read More
Encouraging the FDA to put in place rules that govern the use of AI in healthcare is the focus of a letter Rep. Greg Murphy (R-N.C.) has sent to FDA Commissioner Robert Califf, pointing to the need to clarify liability guidance and overlapping governance, both of which he says are undermining manufacturers. Read More
This edition of Quick Notes looks at recent FDA medical device clearances and designations for EndoSound, EndoQuest Robotics, Perfuze, AnX Robotics, CGBio. Read More
A New Jersey judge ruled last week that Teva Pharmaceuticals did not infringe on two Corcept patents for its Cushing’s syndrome drug Korlym (mifepristone). Read More
The FTC won its motion to temporarily block IQVIA’s planned purchase of California health advertising firm Propel Media, deeming further review by the commission would be in the public interest. Read More