Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.

Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.

The U.S. Federal Circuit’s denial Feb. 11 of an en banc rehearing in a case that could undermine label carveouts and slow the launch of generics is the topic of hallway chatter at this week’s annual conference of the Association for Accessible Medicines.

Ethicon Endosurgery Inc. has had its hands full protecting a patent for robotic surgical systems, but the U.S. Court of Appeals for the Federal recently delivered some good news. The Federal Circuit affirmed the results of an inter partes review (IPR) of three claims for an endocutter patent, leaving Ethicon with another win in its efforts to sustain a critical patent for the robotic surgical space, and major player Intuitive Surgical Inc. coming out on the short end of the argument.

Even as the U.S. Congress continues to kick the can down the road on prescription drug pricing, pressure to finally confront the issue is increasing. But as lawmakers debate price controls via direct Medicare negotiations vs. innovation, along with inflationary caps on price increases, one factor often gets downplayed: the role biologics are playing in the country’s overall spend on prescription drugs. While generics account for 90% of the drugs prescribed in the U.S., the other 10% of drugs prescribed account for more than 80% of the annual spending, according to the Association for Accessible Medicines.

Paragonix Technologies Inc. will soon release performance data from sterile, temperature-controlled systems for transporting donor organs to recipient patients, this after a breath-taking transport last year of a donor lung and heart from Alaska to Washington and North Carolina. Paragonix’s organ preservation technology provides thermal protection for donor organs for up to 40 hours, making them ideal for transportation over long distances, said the company.

The grantmaking process at the U.S. National Institutes of Health has been under scrutiny for several years for several reasons, and a new report by the Office of Inspector General (OIG) indicates that the NIH’s National Cancer Institute (NCI) has generally administered its grants properly. However, the report also indicates that some grantees were tardy in filing their final reports on grant performance, a problem that NCI has vowed to correct with tighter supervision of those grants.

The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.

Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.