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Alto Neuroscience is advancing a depression drug based on the dopamine agonist pramipexole, which an independent study has found to help boost feelings of pleasure in patients with mood disorders.
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DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.
After suffering the market withdrawal of its only product, Amylyx is gearing up for a pivotal Phase 3 readout in post-bariatric hypoglycemia. But the company’s driving ethos is still to treat “debilitating, devastating” neurodegenerative diseases, co-CEO Justin Klee told BioSpace.
Ibogaine’s unconventional “matrix pharmacology” may underlie both its therapeutic promise and unpredictable cardiac risks. Unraveling this mechanism could help drug developers hoping to bring ibogaine analogs to market.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Rhythm Pharmaceuticals’ Imcivree reduced fat—while boosting muscle—in patients with Prader-Willi syndrome.
Eli Lilly’s new JAK2 inhibitor—which it obtained from the recent acquisition of Ajax Therapeutics—reduced spleen volume by more than a third in 70% of patients with myelofibrosis.
Intellia Therapeutics’s Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.
Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.
Novo Nordisk said that the information affected by the breach shouldn’t allow third parties to “identify participants in our clinical trials” despite “unauthorized access” to patients’ personal data.
Strong science, lower costs and growing capital networks are putting Spain and Portugal on the biotech investment map, even as structural bottlenecks persist, according to two investors.
Biotechs are benefitting from the AI tech frenzy and inflation, but validated pipelines and careful planning are still key to the recent record-setting IPOs, experts say.
Takeda eyes an FDA run for its investigational psoriasis pill after the drug elicited total skin clearance in more than 35% of patients at 16 weeks—more than 2.5 times that in controls taking Bristol Myers Squibb’s Sotyktu.