Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review Is Rejected by the FDA
The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients…
The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients with erythropoietic protoporphyria, a rare blood disorder. Analysts say it’s a surprising delay considering bitopertin is one of the first drugs in a new FDA pilot program that speeds up regulatory review of medicines deemed critical for national security or…
Health informatics leaders at NYU Langone Health think fully autonomous clinical AI is coming in the next five years or so, with algorithms soon able to manage routine tasks like blood pressure medication titration and diabetic retinopathy screening without human oversight. They argue automation is not just about efficiency, but also a practical and necessary…
When people hear dosage, they often think of medication. But dosage is a broader clinical concept. It is the structure that makes an intervention legible to clinicians, payers, and regulators. For VR therapy, dosage is the answer to simple questions that are still surprisingly inconsistent across studies and pilots. The post From Pilots to Protocols:…
Shifting healthcare dollars into individual-controlled accounts would mark an inflection point. But even without full policy execution, consumer wallet economics are expanding. The race is now on to build the infrastructure layer between individual spending authority and care delivery. The post When Health Dollars Move to Individuals, Infrastructure Will Decide Who Wins appeared first on…
By CLAUDE.AI trying to write like me MATTHEW HOLT I finally did what I have been wanting to do for a while and had an AI ingest everything I’ve written on The Health Care Blog. Given there’s 20 years of my posts intermingled in hundreds of guest posts, it wasn’t as easy as I’d hoped….
KFF Health News senior contributing editor Elisabeth Rosenthal discussed the cost of cancer care in the wake of James Van Der Beek’s death on ABC News’ ABC News Live on Feb. 12. Click here to watch Rosenthal on ABC News Live. KFF Health News Southern California correspondent Claudia Boyd-Barrett discussed how families of detainees by the U.S….
Anterior raised $40 million to expand its AI platform that automates administrative clinical work for health plans. The system can approve care in minutes rather than weeks, aiming to reduce costs and ease the workload for clinicians and payer staff. The post Anterior Snags $40M to Speed Care Approvals with AI appeared first on MedCity…
It’s February, so open enrollment for the Affordable Care Act is over. We’re getting the first glimpses of how sign-ups are shaking out after the expiration of enhanced subsidies that helped most people with their premium costs. While more Americans enrolled than some policy analysts had expected, the number was still 1.2 million below what it was at the same time last year. And experts say it will be months until the numbers are final. The timing will depend on how many of those people who…
PTC Therapeutics said it cannot resolve differences it has with the FDA in interpreting clinical trial data for Translarna, a drug it developed for Duchenne muscular dystrophy. The rare disease drug developer’s decision to withdraw Translarna’s FDA submission comes nearly a year after a negative European regulatory decision for the drug. The post PTC Therapeutics…
The PERM program measures improper payments in Medicaid through cyclical audits of state Medicaid programs. This brief explains the PERM program and its three component error rates as well as upcoming changes to PERM and possible state impacts.