News
Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
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Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
The new CEO has at least five years and a large M&A war chest to position Sanofi for life after the loss of exclusivity on its cornerstone immunology product.
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
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The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.
Chief Scientific Officer Pedro Beltran will succeed Eli Wallace as CEO of BridgeBio Oncology Therapeutics, as the board eyes a busy period of clinical advancement in the RAS oncology space.
Sanofi’s interim leadership sought on a Thursday earnings call to quell concerns that its sudden defense of Dupixent’s patents had anything to do with the departure of CEO Paul Hudson.
The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.
Roche and Zealand Pharma announced last month that their amylin analog petrelintide elicited a 9% placebo-controlled weight reduction at 42 weeks—falling far below analyst and investor expectations.
This year’s American Academy of Neurology meeting included a presentation that could one day set a new treatment standard for myasthenia gravis.
The Durham plant will manufacture immunology, neuroscience and oncology drugs once AbbVie finishes construction in 2028.
In this episode of Denatured, you’ll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?