Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.

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 committee voted 17-0 that the overall benefit-risk assessment favors the use of maribavir for transplant patients with refractory CMV infections both with and without genotypic resistance to the four antivirals currently used off-label to treat the infections – ganciclovir, valganciclovir, foscarnet and cidofovir.

The least burdensome principle is a critical component in industry’s understanding of the proper role of government regulation, but this principle is the subject of considerable tension between the two sides. The latest report on the FDA’s performance under the fourth device user fee agreement noted that device makers raised the least burdensome flag in less than 0.5% of 510(k) submissions filed between February 2019 and April 2021, but the report gives the agency passing grades on its handling of those potentially controversial regulatory encounters.

The narrative that a little company has little chance of beating a big company in patent lawsuits doesn’t always play out in the real world, and such was the case in a dispute between Snyders Heart Valve LLC and St. Jude Medical. The U.S. Court of Appeals recently handed Snyders a win in the court’s reversal of an inter partes review (IPR) of a Snyders patent for heart valves, the second time in the past year Snyders prevailed over the larger company in a patent hearing at the Federal Circuit.

FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.

The FDA’s push toward safety has included an examination of the materials used in medical devices, but a recent report sheds little useful light on whether these materials are provoking a response in patients.

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.