Phase 3
New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.
The success of apazunersen in a Phase 3 trial for Angelman syndrome was a key driver of Ultragenyx’s value, according to William Blair, and the asset’s failure robs the biotech of any meaningful near-term milestones.
Novartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche’s own BTK inhibitor fenebrutinib.
GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.
Safety and dosing are likely to be “key differentiators” for Arrowhead Pharmaceuticals as it looks to challenge Ionis Pharmaceuticals’ lead in the severe hypertriglyceridemia market.
AstraZeneca and Ionis Pharmaceuticals’ data drop divulging more details from its highly watched Phase 3 transthyretin silencer trial “further confuses the picture” for Wainua when combined with the standard of care for ATTR-CM, analysts say.
AstraZeneca and Amgen co-develop and co-commercialize Tezspire under an April 2012 agreement. The partners are now planning another FDA submission for the asthma drug, which received an expansion into chronic rhinosinusitis last year.
The Phase 3 readout is the first for ivonescimab beyond non-small cell lung cancer to show a significant overall survival benefit, according to Summit Therapeutics and China-based partner Akeso.
The Phase 3 study is evaluating two doses of Novo’s Wegovy pill in people with obesity or overweight in combination with a reduced-calorie diet and increased physical activity.
Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.
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