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While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
Roche’s obesity candidate achieves 22.5% weight loss in Phase II; Moderna pulls the plug on late-stage vaccine trials as Health Secretary Robert F. Kennedy’s anti-vaccine policies and rhetoric continues; and embattled gene therapy maker Sarepta announces new data in Duchenne muscular dystrophy.
While Baseline Therapeutics declined to disclose its starting capital, the startup said it will use the funds to push its GLP-1 asset BT-001 into late-stage development, with two trials planned this year.
With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Investors are apparently taking bets on when Revolution will be acquired. A handful of pharmas could be interested as Merck backs off.
Corxel will use the fundraising proceeds to advance the oral GLP-1 therapy CX11 through mid-stage development in the U.S., as well as prepare for its Phase III studies.
Growing opposition to vaccines in the U.S., driven by recent government policy changes, makes it difficult to see a return on investment in vaccine development, Moderna CEO Stéphane Bancel said this week.
The partnership will allow BMS to advance a T cell–based therapy that is only activated once in the vicinity of a tumor.
In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their post-JPM takeaways and 2026 forecasts after speaking to a range of pharma and biotech executives and investors last week.
Fueled by advances in biomarkers, brain mapping, and AI, investment in neuro and CNS innovation shows no signs of slowing, even amid costly setbacks. BioSpace spoke to investors at JPM26 to get their take on recent bets in new therapies and neurotech.