The FDA on Wednesday published new draft guidance outlining how biosimilar developers can cut out Phase 3 comparative efficacy studies, potentially reducing development timelines and cutting costs. The move, first disclosed by FDA Commissioner Marty …
Botnets Step Up Cloud Attacks Via Flaws, Misconfigurations
Infamous botnets like Mirai are exploiting Web-exposed assets such as PHP servers, IoT devices, and cloud gateways to gain control over systems and build strength.
After this year’s Nobel Prize, the first results for a CAR-Treg for autoimmune disease are in
Sonoma Biotherapeutics reported early data for its regulatory T cell therapy that showed it can help tamp down inflammation in certain arthritis patients. The data, which were presented Wednesday at the …
What Novo Nordisk might be planning to turn the ship around
Maziar Mike Doustdar will lead his first Novo Nordisk earnings call next week. He’ll have many keen observers. In his three short months atop Novo, the Danish drug giant has undergone a vast revamp. …
Novo Nordisk’s direct-to-patient platform gains momentum as self-pay sales rise
Consumers are having an entirely different relationship with how they access weight loss drugs, buying them even if there isn’t insurance coverage. And it’s pushing drugmakers to act differently. “It’s not a normal thing for …
Building a high performance data and AI organization (2nd edition)
Four years is a lifetime when it comes to artificial intelligence. Since the first edition of this study was published in 2021, AI’s capabilities have been advancing at speed, and the advances have not slowed since generative AI’s breakthrough. For example, multimodality— the ability to process information not only as text but also as audio, […]
Kyverna says small group of rare disease patients all responded to its CAR-T
Kyverna Therapeutics reported positive rare disease data on Wednesday morning, saying that a small cohort of generalized myasthenia gravis (gMG) patients all responded to its cell therapy treatment. In the Phase 2 portion of a …
Recursion gets $30M from Roche; Chinese siRNA biotech to go public in Hong Kong
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MSD, Eisai abandon combination trial in liver cancer
MSD and Eisai’s oncology partnership has had mixed fortunes this week, with a disappointment in liver cancer and encouraging data in kidney cancer.
Regeneron teams up with Gary Nabel’s ModeX on multispecifics
For decades, Regeneron has been known for its antibody expertise. It’s now enlisting the help of a biotech run by former NIH leaders to beef up its R&D in the multispecific antibody arena, as bispecifics …