The term of follow-up in clinical studies is the subject of massive speculation at FDA advisory hearings, but a recent FDA workshop suggests the agency may adjust its expectations, depending on the device. Darrell Brodke, of the University of Utah, said on a recent spinal device workshop that the two-year endpoint in some spinal device studies struck him as somewhat arbitrary, adding that a longer duration of follow-up is necessary to capture some device failures, but that two years is perhaps overly long where some other outcomes measures are concerned.

Isoplexis Corp. has debuted on the Nasdaq, pricing its initial public offering of 8.3 million common shares at $15.00 per share. Shares of the proteomics platform developer (NASDAQ:ISO) were trading slightly under at $13 following the listing. The offering is expected to close on Oct. 12, 2021. The Branford, Conn.-based company is aiming to raise $125 million from the public market to accelerate commercialization of its cell analysis platforms. The single-cell proteomics systems are automated, benchtop products designed to reduce therapeutic development timelines.

The U.S. Office of Inspector General (OIG) said a review of claims for implant of neurostimulation devices indicates that many of these claims lack the data to ensure that the devices were appropriately implanted.

Even though the U.S. already has a National Plan to Address Alzheimer’s Disease, a bipartisan group of U.S. senators is adding its voice to that of nearly 200 national organizations and experts in calling for more. In a recent letter to Health and Human Services (HHS) Secretary Xavier Becerra, the 15 senators requested that he make reducing the prevalence of dementias a departmental priority.

If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.

The America Invents Act (AIA) is barely 10 years old, but a bipartisan pair of U.S. senators have proposed patent reform legislation that would amplify the use of the inter partes review (IPR) process to challenge an existing patent. There are several critical features of the new legislation, but Sens. Patrick Leahy (D-Vt.) and John Cornyn (R-Texas) said the legislation would relieve the problem of poor-quality drug patents that “drive up the costs of prescription drugs.”

Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy.

The FDA’s final rule for the de novo petition process took nearly three years to wrap up, a timeline likely extended by the COVID-19 pandemic, but the final rule retains some controversial features seen in the 2018 draft. Among these is a provision for FDA inspections before determining whether to grant the petition, a provision that was blasted by multiple commenters as extra-statutory and a needless source of drag on these applications.