Regulatory
Week in Review: Novo Nordisk Riding High, Novavax in the Black (For Now), Nektar Sues Lilly and More
Novo’s weight-loss drug Wegovy improves cardiovascular outcomes, Novavax posts surprise Q2 profit, while Nektar Therapeutics files lawsuit against Eli Lilly for misconduct in drug development deal.
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
After the regulator rejected avasopasem manganese, its candidate for severe oral mucositis, Galera is implementing a restructuring initiative that involves reducing its headcount by 70%.
The vaccine maker cut 25% of staff amid post-pandemic business challenges in May, but resurgent sales and an updated COVID-19 shot may prove a turning point.
The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff.
For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
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