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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.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners’ Datroway for a related type of breast cancer.
Starboard last year took a $1 billion stake in Pfizer, looking to turn the pharma around after alleged severe shortcomings by its current leadership. But Bloomberg reports it has missed the deadline for nominating a director to the pharma’s board.
Little information has emerged about osavampator, a potentially first-in-class drug, since its promising Phase II performance last spring.
After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.
IPO
The GLP-1 IPO arena has been heating up for the past two years and Metsera’s ask is one the largest in recent history.
After missing the primary endpoint in the Phase IIb SYMMETRY trial, Akero Therapeutics’ lead molecule, efruxifermin, showed greater improvements after 96 weeks of treatment in an advanced disease population.
Following disappointing clinical trial results for AK006, Allakos will cut its workforce down to under 20 employees as it explores strategic alternatives.
Following a lawsuit filed last week, Sage has officially rejected Biogen’s unsolicited buyout offer, which valued the embattled biotech at just $469 million.
Patients taking Novo Nordisk’s Wegovy plus Veru’s enobosarm saw 71% lower lean mass loss than those who were taking Wegovy alone but investors await more data.
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.