Phase 2a study completes enrollment as biotech tests whether treating joint inflammation could slow osteoarthritis, not just ease pain. #longevity# #geroscience# #osteoarthritis# #inflammation# #clinicaltrial#

NewLimit CEO @jacobkimmel explains the clinical trial bottleneck AI can't fix: biology has irreducible latency "It's unlikely we're gonna see rapid expedition of clinical trials because a lot of the periods of time can't be expedited based on the biological primitives. In computer science you often have a notion of bandwidth and latency." "There are some irreducible latencies in clinical trials. If you wanna give a drug to a patient and see if they're healthy a month later, it's not like you can enroll 30 patients and check back in one day. You just need to wait a full month. The classic nine people can't have a baby in one month story." "The other thing we can hope for is that the success rate might improve. Right now, rough math, roughly 9 out of 10 drugs that go into the clinic will ultimately fail." "If you're able to even just 2X that success rate, getting to 20% success rather than 10%, then you would double the number of drugs that come out every year, and you would cut the effective cost in half." @newlimit

A randomized double-blind placebo-controlled clinical trial of a multi-target therapeutic against primary age-related feline sarcopenia: PURR-001 [ “ PURR-001 enteric capsules contained a nominal dose of 0.5 mg mTOR inhibitor, 2 mg mirtazapine and 10 mg acarbose]👇 “This is the first randomized placebo-controlled clinical trial to demonstrate the efficacy of a pharmaceutical intervention for primary age-related sarcopenia in cats, providing a foundation for larger confirmatory studies of gerotherapeutic interventions in companion animals...”

One of the biggest pharma companies in the world just got caught manipulating clinical trial data on a $3.7 billion drug. Patients are dying of liver failure. The FDA wants it pulled immediately. But Amgen is refusing. Here is what happened: In 2021 a tiny biotech called ChemoCentryx won FDA approval for Tavneos, a pill for a rare autoimmune disease called ANCA vasculitis. The FDA's own advisory committee had flagged concerns about the data. But approval went through anyway. A year later Amgen paid $3.7 billion to acquire ChemoCentryx for one reason: This single drug. CEO Robert Bradway called Tavneos "a terrific medicine, the first innovation in this space in more than 10 years." Then three years later the FDA discovered something through a securities fraud lawsuit filed against ChemoCentryx by its own shareholders: Court records showed that ChemoCentryx personnel handpicked 9 trial participants for "readjudication" after the original statistical analysis showed the drug did NOT actually work. 5 of those 9 had their clinical outcomes changed from "not in remission" to "sustained remission." The company then submitted the application for approval without ever disclosing the original analysis to the FDA. The FDA's own letter from April 27, 2026 quotes it directly: "Unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion." The agency's conclusion was even more brutal: "CDER can no longer conclude that there is, or has ever been, a valid demonstration that Tavneos is effective." Then the post-market safety reports started rolling in. The FDA has documented multiple cases of serious drug-induced liver injury linked to Tavneos. Some have been fatal. Most of the deaths occurred in Japan, where the drug was also approved. In January 2026 the FDA asked Amgen to voluntarily withdraw the drug. But Amgen refused. And the reason is purely financial. Tavneos generated $459 million in revenue in 2025, up 62% year over year. Amgen NEEDS this growth desperately. Prolia and Xgeva lost patent protection last year. Repatha and Enbrel lose protection in 2028. Those four drugs combined represented $11.7 billion in annual sales. Tavneos is supposed to plug the hole. So instead of pulling it, Amgen has hired its own consultants to "independently" reanalyze the exact data the FDA has already concluded was manipulated. The company has formally requested a public hearing to defend the drug. The hearing has not been scheduled. Roughly 8,000 patients are currently being prescribed Tavneos worldwide. This is the third largest biotech in America defying the FDA's direct request to pull a drug the agency has formally concluded was approved based on fraud and is now associated with patient deaths. Amgen approved a $3.7 billion acquisition of a single-drug company on the basis of clinical data the FDA has now concluded was manipulated before the acquisition even closed. Either Amgen knew about the data problems and bought the company anyway, or the most expensive due diligence process in pharmaceutical history failed at the highest level. Both options are scary. Why is a drug that the FDA has formally concluded was never proven effective, and that is linked to fatal liver injuries, still being prescribed to thousands of patients in the United States today? The FDA has the legal authority to forcibly withdraw approval after a public hearing but it has not used that authority yet. Amgen is gambling that the political weight of the pharmaceutical lobby will outlast the regulatory will of an FDA Commissioner who built his reputation on cracking down on the industry. The drug is still on shelves. Prescriptions are still being written. How does this end?

In today's pharma news: • The FDA approves a Roivant drug to treat rare autoimmune disease • AstraZeneca details the surprise failure of a heart disease clinical trial • Florida AG files antitrust lawsuit against two major PBMS Read more: