Europe
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
The Danish biotech on Thursday reported stronger-than-expected earnings and forecasts hitting the upper range of its full-year revenue target amid the ongoing mpox outbreak.
While approved by the Medicines and Healthcare products Regulatory Agency, the Alzheimer’s drug failed to win the backing of the U.K.’s National Institute for Health and Care Excellence, which said that its benefits were “too small to justify the cost.”
Patients taking Novo Nordisk’s blockbuster GLP-1 drug appear to be more likely to harbor thoughts of suicide or self-harm, especially if they are already suffering from anxiety or depressive disorders, according to a new study.
Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
The Danish company on Saturday announced plans to increase production of its vaccine Jynneos on the heels of the World Health Organization last week declaring mpox a global health emergency.
The companies’ late-stage stumble could allow Moderna to widen its lead, with its mRNA-based combination vaccine eliciting superior immune responses against COVID-19 and three influenza strains.
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
The company can make 10 million doses available next year, with $600 million to $1 billion in revenue potential into 2025, “albeit perhaps lower on price, discounts and donations,” according to Jefferies analyst Peter Welford.
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