Drug Development
Approved by the FDA in July to treat adults with early symptomatic Alzheimer’s disease, Eli Lilly’s Kisunla reduced the brain swelling of patients in a late-stage trial following an adjusted dosing regimen.
FEATURED STORIES
As therapies for rare and neurological diseases earn accelerated approval, experts laud the program’s intent while remaining concerned about confirmatory trials and clinical efficacy, especially as products greenlit under this pathway are pulled from the market.
Pfizer CEO Albert Bourla is in a tough spot as activist investor Starboard Value continues to call for a change in the company’s leadership. However, analysts are supportive of the embattled executive.
Pharmaceutical companies are combining antibodies with radioisotopes in a bid to more precisely deliver radiation to cancers and tumors.
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Bank of America analysts said prior to Thursday’s readout that Tyra Biosciences’ TYRA-300 could rival Johnson & Johnson’s kinase inhibitor Balversa, which has suffered from safety concerns and poor tolerability.
Jefferies analyst Maury Raycroft said in a note to investors that Thursday’s mid-stage readout pointed to the “unprecedented” complete response rate of Intellia’s investigational in vivo gene editing therapy in the disorder.
Researchers have linked Novo Nordisk’s semaglutide to a 40% to 70% reduction in the risk of Alzheimer’s disease diagnosis in a study of medical records from 1 million patients.
While the regulator has not approved their use in type 1 diabetes, off-label prescribing for GLP-1 receptor agonists has sharply increased, according to researchers, who warn about the risk of serious side effects such as ketoacidosis.
Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation.
Yet another therapy with FDA accelerated approval suffers a setback; Sage’s tough year continues; Sanofi drops $326 million in radiopharma while selling its consumer health unit; Novo Nordisk’s positive Rybelsus results in cardiovascular disease; and more.
Alto Neuroscience’s depression treatment failed to beat placebo just nine months after the biotech went public. The stunning failure called to mind Acelyrin, which faced a similar fate last year.
Roche drops a third Alzheimer’s candidate this year, terminating a partnership with UCB just four years after agreeing to work together on new treatments for the neurological disease.
Novo Nordisk on Monday reported the oral version of its drug semaglutide reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes by 14% in a large Phase III trial.
In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.