Morning Briefing
Summaries of health policy coverage from major news organizations
Montana To Open Up Unapproved, Experimental Drugs To Consumers
Politico: Montana’s Giving The Biotech Industry Sweeping Authority To Sell Unapproved Drugs
Investors on the libertarian fringe of the biotech industry are making their dream of widespread access to experimental drugs a reality in Montana. Last year, they helped draft a state law to expand access to drugs that no regulator has deemed safe and effective. Now, Montana is relying on a privately run board to decide which treatments to offer — raising concerns about conflicts of interest and, in an industry rife with unfounded claims, whether patients will get value for their money. (Chu, Brueck and Macho, 9/15)
The Wall Street Journal: Trump Administration Shift Puts This Corner Of Biotech Back In Favor
Betting on biotech is always a gamble. But in the first year of the Trump administration, few corners were dicier than rare-disease drugmakers. These companies often test drugs in tiny patient groups, sometimes without the usual features of large trials, such as placebo controls. In the second Trump administration, they suddenly found themselves facing Food and Drug Administration officials skeptical of approving drugs on such limited evidence. Rare-disease shares plunged. (Wainer, 9/16)
More pharma and tech developments —
Stat: FDA Launches Pilot Program To Shorten Drug Approval Times
The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. (Manto, 9/15)
Los Angeles Times: New Lung Cancer Drug Lifts Survival Versus Chemotherapy
BioNTech said its experimental drug gotistobart nearly doubled the median survival of patients with an aggressive form of lung cancer compared with chemotherapy. Patients treated with gotistobart lived for a median 18.5 months, compared with 10 months for those given the standard-of-care chemotherapy, BioNTech said in a release this week. The updated results are from a late-stage study evaluating patients with metastatic squamous non-small cell lung cancer whose disease progressed when they were undergoing prior immunotherapy and chemotherapy. (Wind, 9/15)
Fox News: Common Antibiotic Cefepime Tied To 94% Higher Death Risk, Study Finds
A commonly used drug has been linked to a higher risk of death in a new study. The antibiotic, cefepime, which is used to treat bacterial infections like pneumonia, UTIs and skin infections, is typically administered via injection by healthcare providers in a clinical setting. (Stabile, 9/15)
MedShadow Foundation: What To Know About Simtriyo, A New FDA-Approved ADHD Medication
Simtriyo is being promoted as a new kind of ADHD drug that may help with emotional dysregulation. But the strongest evidence so far is for core ADHD symptoms, and questions remain about how it compares to existing treatments. (Tjandra, 9/11)
Bloomberg: HIV Prevention Falters As Funding Cuts Hit PrEP Treatment Access
Global efforts to prevent HIV lost ground last year as funding disruptions forced countries to scale back services, even as health systems managed to put more people living with the virus on lifesaving treatment. About 1.1 million people received pre-exposure prophylaxis, or PrEP, last year in countries where the Global Fund invests, down 21% from 2024, according to the organization’s annual results report. HIV prevention services were scaled back or suspended in many countries as reductions in domestic and international funding squeezed health programs. (Kew, 9/16)
Also —
The New York Times: ‘I Have A Lot To Say’: Brain Implant Helps A Disabled Patient Speak
In a step forward for the cutting-edge field of brain-computer interfaces, a patient with a paralyzing neurological disorder used a brain implant to converse in real time, even when she was simply thinking about what to say, a company said it would announce on Monday. The development, by the company Paradromics, marks the latest advance for these experimental devices, known as B.C.I.s — systems that involve implanting electrodes in the brain that read neurological signals and decode those signals through artificial intelligence. (Belluck, 9/14)
