Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Biogen, Chinook, Coherus, Junshi, Inflarx, Kazia, Olix, Pyramid, Roche, Sensorion, Takeda,  Titan, Turnstone.

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.

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.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmab, Hyloris, Novartis, Nrx, Provention.

As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.