En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.
A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the U.S. Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several recent examples of this kind of fraud.
Rolling out guidance to help pharma manufacturers provide direct-to-consumer drugs at lower prices, the U.S. Department of Health and Human Services (HHS) clarified ways to eliminate the middlemen while still abiding by the federal anti-kickback statute.
The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.
Although the American Academy of Pediatrics has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued Jan. 26 is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations.
Following a clinical hold last October of Intellia Therapeutics Inc.’s Magnitude and Magnitude-2 phase III trials of CRISPR/Cas9 gene editing therapy nexiguran ziclumeran (nex-z) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively, the U.S. FDA lifted the hold on Magnitude-2, pushing the company’s shares up by 22% in early trading Jan. 27.
The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals recorded in 2024 but well above approval numbers seen in most prior years of the past decade.
After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
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