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Good morning! Before we get to biotech, check out STAT’s deep dive into how UnitedHealth mobilizes a massive network of physicians and milked the health care system for profit.
The need-to-know this morning
Viking accelerates development of obesity drug that could rival Wegovy, Zepbound
Viking Therapeutics plans to move its injectable obesity treatment into a Phase 3 study faster than expected, bringing the biotech closer to joining the highly competitive GLP-1 drug market.
The San Diego-based biotech previously said it was anticipating the start of a Phase 2b trial of the therapy, VK2735, after getting positive results from a Phase 2 study. But after receiving feedback from regulators, the company now plans to advance directly into a Phase 3 trial, the company said yesterday when reporting earnings.
Jiankui He has a new lab in a medical tourism hub
Jiankui He, the Chinese scientist notorious for creating the first gene-edited children in 2018, has a new lab to call his own. Since his release from prison in 2022, he’s been struggling to regain a foothold in the scientific community.
Now, He has relocated to a private lab in Sanya, Hainan — a region known for its medical tourism. It provides a regulatory zone that allows access to medical products licensed in foreign countries but not yet approved in China.
“Here everybody is very friendly to me and willing to provide me with a large enough space and financial support,” He told STAT’s Megan Molteni.
Does the FDA even know how to regulate MDMA therapy?
Thomas Insel, who once led the National Institute of Mental Health, was not at all surprised last month that an FDA advisory committee voted against approving MDMA-assisted psychotherapy for PTSD. Opining for STAT, Insel writes that the FDA generally overlooks the significant role psychotherapy plays in the efficacy of psychiatric drugs — and that this must change.
“The combination is the overlooked innovation of this new drug application,” Insel writes. “People with severe mental illnesses need a regulatory process that addresses this innovation as a feature, not a bug.”
DOJ misconstruing kickbacks for rare disease testing
Advances in genetic testing are making it easier to identify rare diseases — but the testing is rarely covered by insurers. When biotechs step in and offer to pay for testing, however, the Department of Justice has begun to call these “kickbacks” to the physician making the orders. This impedes care for many rare disease patients who are already on a painful diagnostic odyssey, opines Emil Kakkis, CEO of Ultragenyx, a biotech specializing in ultra-rare disease.
Ultragenyx and other biotechs are under DOJ investigation, Kakis notes, for sponsoring testing for a rare disorder.
“There were no kickbacks or false claims,” he writes. “Without the tests we sponsored, many patients ultimately diagnosed with the disorder would continue to suffer from an unknown disease without proper care.”
More reads
- Pharma aims to deliver personalized cancer therapies more quickly, Reuters
- BeiGene CEO eyes biologics deals for new US innovation center in New Jersey, FierceBiotech
- U.S. bankrolls a third of global Pandemic Fund. Can it get congressional support? Endpoints