The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.

A few months after disclosing its merger with Chiasma Inc., Amryt plc rolled out second quarter financials pleasing to Wall Street, where considerable interest has begun to manifest in the company’s epidermolysis bullosa program with Filsuvez, also known as Oleogel-S10.

The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.

Given the FDA’s Vaccines and Related Biological Products Advisory Committee’s unanimous vote last month to recommend use of a booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine in certain high-risk groups, it came as no surprise when the committee again voted unanimously Oct. 14 for a mirror use of Moderna Inc.’s proposed booster.

The FDA’s device center has posted a draft guidance that addresses unique device identifier (UDI) code requirements applied to low-risk products. The select update offers enforcement discretion in some instances for class I consumer health products, a switch partly justified by the exceedingly low risk presented by such products.

Device makers have argued for years that not all medical device recalls are the same, and thus the FDA should be more forthcoming with the public about the difference between a recall that is accompanied by a market withdrawal and a recall that driven by something as innocuous as a minor adjustment to the product label.

Alpha Tau Ltd. has secured a second breakthrough device designation for its Alpha Dart radiation treatment for solid cancer tumors. The FDA has granted the Jerusalem-based company’s technology a designation for the treatment of patients with recurrent glioblastoma multiforme (GBM), an aggressive malignant brain tumor. GBM has an average five-year survival rate of less than 10% and is the most common malignant tumor of the brain or central nervous system. According to the designation, the Alpha Dart system can be used to treat recurrent GBM as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted.

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.