Policy
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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The new legislation could increase healthcare spending overall while reducing biopharma’s return on investment on biologic drugs.
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.
A Louisiana woman has filed a lawsuit alleging that Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro did not have warnings about the risk of severe gastrointestinal problems.
Savings from just four of 10 drugs covered by the Inflation Reduction Act’s Drug Negotiation Program could reach $1.8 billion during the first year of implementation, according to research.
The lawsuit alleges that Pfizer infringed GSK’s patents on respiratory syncytial virus shots. The complaint comes just months after both companies had their respective RSV vaccines approved.
Early research and anecdotal evidence indicate that the popular diabetes and obesity drugs could treat some patients with addictive disorders.