The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
FDA Reverses Course on Moderna’s mRNA Flu Shot Application, Promising August Decision Read More »
The regulation required firms to provide more details ahead of mergers, likely chilling dealmaking. The Federal Trade Commission could appeal the ruling.
Federal judge strikes down FTC rule expanding premerger reporting requirements Read More »
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
Court Rejects Two Moderna Defenses in mRNA Vaccine Patent Row With Arbutus Read More »
Korsana’s lead program uses a next-generation shuttling technology to improve delivery into the brain and lower the incidence of amyloid-related imaging abnormalities.
Korsana Joins Alzheimer’s Amyloid Arena With $150M Debut, Next-Gen Antibody Read More »
CSL is advancing clazakizumab for the treatment of cardiovascular events in end-stage kidney disease and will retain rights over the asset in this indication. Lilly will explore other conditions.
Lilly Fronts $100M for CSL’s IL-6 Blocker to Bolster I&I, Cardiovascular Pipeline Read More »
The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have had a hand in; Compass Pathways posts new late-stage data on its psilocybin-based depression drug; CDC is once again leaderless.
Modernagate Fallout, Disc’s Rejection, Compass’ Psilocybin Data, CDC’s Lost Leaders Read More »
Una de las grandes incógnitas que dejó la pandemia provocada por el coronavirus SARS‑CoV‑2 fue por qué una enfermedad respiratoria como la COVID‑19, generalmente leve en la mayoría de los casos, provocó cuadros muy graves en determinadas personas sin patolog& …
Variante genética asociada a un mayor riesgo de sufrir COVID-19 grave Read More »
La infertilidad afecta al 15% de la población mundial, siendo los factores masculinos responsables del 40-50% de estos casos de infertilidad. En este problema, que se ha agravado en las últimas décadas, los factores vinculados a las exposiciones ambientales y derivadas del estil …
La historia de la tecnología moderna no puede entenderse sin el transistor, el pequeño dispositivo que hizo posibles los ordenadores personales, los teléfonos móviles y prácticamente toda la electrónica actual. En el centro de esta revolución se encue …
Unos científicos han desarrollado un dispositivo portátil, cómodo y lavable llamado Revoice que a las personas con dificultades para hablar debido a un derrame cerebral podría ayudarlas a comunicarse verbalmente de forma natural y fluida, sin necesidad de implantes cerebr …
