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Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More
A consent decree of permanent injunction against Philips Respironics restricting the production and sale of new CPAP and BiPAP machines and mechanical ventilators at three U.S. facilities has been entered by the U.S. District Court for the Western District of Pennsylvania. Read More
While Johnson & Johnson just announced its plans to acquire Shockwave Medical for $13.1 billion, Boston Scientific faces an FTC request for more information on its $3.7 billion acquisition of Axonics. Read More
Three medical devices — radial artery and arterial line catheterization kits, a neurovascular catheter, and gas-powered portable ventilators — have been deemed Class I, the FDA’s most serious type of recall. Read More
This edition of Quick Notes reviews Merck’s pulmonary arterial hypertension treatment with Winrevair, a fourth approval for AstraZeneca’s Ultomiris, Akebia approval for Vafseo tablets and another clearance for Neuronetics’ Neurostar device. Read More
The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed. Read More
The FDA has identified product recalls for Vyaire’s AirLife Manual Resuscitators and for the use instructions for Abiomed’s left-sided heart pumps as Class I, while device manufacturer InfuTronix is voluntarily recalling its line of Nimbus Infusion Pumps after design flaws prompted thousands of customer complaints. Read More