The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.
Johnson & Johnson launched its latest pulsed field ablation (PFA) catheter, Varipulse Pro, in Europe following CE mark approval, bringing another option to electrophysiologists looking to adopt PFA technology. The system features a new pulse sequence with a lower temperature profile and enables ablation that is five times faster than the previous sequence, while achieving equivalent lesions. It represents another significant development in the rapidly evolving PFA market that has transformed cardiac ablation treatment.
Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).
Seeking to increase their understanding of the opportunities and challenges of using digital health technologies (DHTs) in drug trials, the U.S. FDA’s CBER and CDER are requesting public feedback to help inform new guidance as the technologies continue to advance.
What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.
With all the focus of late on the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA’s 30-plus advisory committees have been flying under the radar, especially since many of them haven’t met for a few years now.
The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.
A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
With incidence of kidney cancer rising in the U.K., the National Institute for Health and Care Excellence (NICE) published its first comprehensive guidelines for diagnosing and treating the disease.
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