The U.S. International Trade Commission (USITC) is launching an investigation into the importation from China of certain thyroid hormone receptor-beta agonists, products containing them and the manufacturing processes being used.
A federal court cut off efforts Feb. 6 to halt a U.S. program allowing prescription drug imports from Canada before the program gets off the ground. The U.S. District Court for the District of Columbia dismissed a suit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations, saying that they lacked standing because neither they nor their members face “a concrete risk of harm from the inchoate importation program.”
While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency.
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to enable broad genus claims, both Sanofi SA and Amgen Inc. are warning that future innovation will be at stake if the court accepts the other company’s position.
Orthogen AG received an investigational device exemption (IDE) from the U.S. FDA for its Orthogen technology device. This approval allows the company to start a pivotal trial on the device, used for treating patients with mild stage (II) to severe stage (IV) knee osteoarthritis. The trial will compare improvements in pain levels and function using standalone glucocorticoid injection, the current standard of care, against the Orthogen device.
The Medical Device Manufacturers Association (MDMA) has led the policy charge for smaller medical device manufacturers for decades, but each year brings its own unique set of hazards and opportunities. In an interview with BioWorld, MDMA President and CEO Mark Leahey said that while the Medicare policy for coverage of breakthrough devices has gone through some unanticipated twists and turns, that policy is not yet fixed and thus there is still some prospect that such a policy will not devolve into a stew of leftovers drawn from existing coverage mechanisms.
Researchers at Indiana University School of Medicine are exploring avenues to heal wounds by identifying proteins that are active in fetuses, but largely inactive in adults and absent in diabetic adults. They have identified a protein called nonselenocysteine-containing phospholipid hydroperoxide glutathione peroxidase, or NPGPx, that fits the bill and could be the basis for therapies aimed at diabetic wound healing. NPGPx is a direct transcriptional target of miR-29. miR-29 is downregulated in fetal tissue, thus NPGPx is active in fetal tissue but becomes mostly inactive in the skin after birth.
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