1. FDA approves Hibsago, the first antisense drug for chronic hepatitis B
A finite injectable course let about one in five eligible trial patients stop all hepatitis B treatment.
On October 20 the FDA approved GSK's Hibsago (bepirovirsen), given alongside antivirals, for certain adults without cirrhosis whose virus is suppressed and whose HBsAg is 3,000 IU/mL or lower [1]. In two placebo-controlled trials, 19% of recipients still had the virus controlled and HBsAg undetectable 24 weeks after stopping all treatment; the label carries a boxed warning for serious liver reactions and low platelet counts [1]. (See lead article.)
2. Philips Lumify handheld ultrasound correction classified as Class I recall after four deaths
The FDA has given its most serious recall rating to a software and cable problem that can stop the portable scanner from working.
The FDA classified the Philips Lumify correction as a Class I recall on October 19 [2]. The Lumify app may fail to recognize a previously registered transducer and demand re-registration, which needs a Wi-Fi or cellular connection, before scanning can begin, and the cable connection to the phone or tablet may disconnect during use; Philips has reported eight serious injuries and four deaths as of September 29 [2][3]. The action updates use instructions rather than removing devices, so units remain in service [2].
3. Maryland man convicted in $18.7 million Medicare respiratory-testing fraud aimed at nursing homes
A federal jury found that a lab owner billed Medicare for tests no physician ordered, including for residents who had already died.
The Justice Department said on October 20 that a jury in Maryland convicted Patrick Britton-Harr, 42, of Annapolis, of five counts of health care fraud and one count of money laundering [4]. According to evidence at trial, after offering COVID-19 testing to nursing homes in 2020, he billed Medicare $18.7 million over six months for respiratory pathogen panels that physicians never ordered, some purportedly run at an Arizona lab he had already closed; Medicare paid more than $7.2 million [4]. Each count carries up to 10 years in prison, and sentencing has not been scheduled [4].
4. Illinois lab owner charged in alleged $66 million COVID-19 testing fraud
Prosecutors allege a lab issued at least 380,000 "negative" PCR results for tests it never ran.
An indictment announced October 20 charges Rajesh "Raj" Patel, 52, co-owner of a Hillside, Illinois, laboratory, with five counts of wire fraud [5]. Prosecutors allege that from May 2021 to April 2022 he created fake negative results for at least 380,000 tests in order to bill a federal program covering COVID-19 testing for uninsured people, submitting about $66.2 million in claims, of which about $44.1 million was paid [5]. The charges are allegations, he is presumed innocent, and the DOJ release includes no response from the defendant [5].
Digest references
US Food and Drug Administration. "FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment." FDA, October 20, 2026. Link
US Food and Drug Administration. "Diagnostic Ultrasound System Correction: Philips Ultrasound Issues Updated Use Instructions for Lumify Diagnostic Ultrasound System." FDA, updated October 19, 2026. Link
Medical Daily. "Philips Lumify Ultrasound Flaw Linked to Four Deaths Draws Class I Recall, but Devices Stay in Use." Medical Daily, October 21, 2026. Link
US Department of Justice, Office of Public Affairs. "Maryland Man Convicted for $18.7M Medicare Fraud Respiratory Testing Scheme Targeting Nursing Homes." Press release, October 20, 2026. Link
US Department of Justice, Office of Public Affairs. "Illinois Laboratory Owner Charged in $66M COVID-19 Testing Fraud Scheme." Press release, October 20, 2026. Link
