The U.S. FDA’s efforts to improve medical device quality includes a recent draft guidance that pertains to the pilot version of a voluntary improvement program, but stakeholders see a number of critical issues with the draft. A coalition of device makers said this pilot program should include disclosure guardrails that parallel similar guardrails provided for medical device reports (MDRs), a provision related to discovery during product liability litigation that is seen as critical if device makers are to take part in the voluntary improvement pilot.
While the U.S. Congress struggles to patch together statutory restraints on prescription drug prices, the U.S. Patent and Trademark Office (USPTO), with the FDA’s help, is taking steps to cut back the patent thickets some drug companies are using to ward off the competition that would bring those prices down.
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the court has declined to hear the American Axle case, leaving many observers despairing of any chance of restoring a decent patent system for personalized medicine, companion diagnostics and even the use of artificial intelligence in drug development.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Aneurotech, Dyne, Hyloris, Novavax, Pfizer, Sanofi, Xbrane.
Lung cancer claims more lives each year than any other cancer, making early and accurate diagnosis crucial to improving survival rates. To that end, the U.S. FDA has cleared the integration of Intuitive Surgical Inc.’s Ion endoluminal system and Siemens Healthineers AG’s Cios Spin mobile imaging cone-beam CT imaging technology to enhance robotic lung biopsies.
Two Israeli companies aiming to improve in vitro fertilization (IVF) success rates received good news recently, with Aivf Ltd. hauling in $25 million in a series A round for Ema, its IVF software platform, and Fairtility Ltd. gaining CE mark for its CHLOE EQ embryo quality decision-support tool.
The U.S. FDA is hailing two revised draft guidances it released July 5 as “critical steps” toward implementing the electronic drug tracing requirements of the Drug Supply Chain Security Act.
Curevac NV has filed a patent lawsuit against fellow German mRNA pioneer Biontech SE claiming that the latter firm’s COVID-19 vaccine, Comirnaty, infringes its intellectual property.
A U.S. federal jury breathed new life into so-called pay-for-delay settlements when it found that a 2010 agreement between Endo International plc and Impax Laboratories LLC was procompetitive as it allowed Impax to launch its generic version of Opana ER, an opioid pain drug, before key patents expired.
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