Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).

With an FDA 510(k) clearance now in hand, Cloudcath Inc. is planning a phased launch of its remote monitoring platform for peritoneal dialysis (PD) patients. The company will make the system available on a limited basis in second half of 2022 “with broad U.S. availability increasing throughout 2023 and 2024,” Cloudcath CEO Aly ElBadry told BioWorld. The Cloudcath system continuously analyzes the dialysate fluid used in PD to detect early signs that a patient needs evaluation or intervention and then alerts both patients and clinicians.

The U.S. CMS has expanded the population of Medicare beneficiaries who are eligible for lung cancer screening via low-dose CT (LDCT) imaging. The news drew raves from stakeholders who also lauded the expansion of the facilities that can conduct the procedure, constituting a set of changes that advocates say will save thousands of additional lives.

The U.S. FDA has granted Datar Cancer Genetics Ltd. a breakthrough device designation for a blood test to detect early-stage prostate cancer. The circulating tumor cell (CTC) detection blood test can identify early-stage prostate cancer in men of age 55-69 years at around 99% accuracy.

The U.S. Senate narrowly voted 50-46 to confirm Robert Califf as the next commissioner of the FDA, a critical outcome for an agency that has lacked a fully anointed commissioner for a year. Califf, who was previously FDA commissioner under President Barack Obama from February 2016 to January 2017, faces several challenges in the coming year, however, including the agency’s accelerated approval program for prescription drugs, which has added drag to the process of registering him as the new commissioner.

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.