If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.
EU proposal would simplify Medical Device Regulation Read More »
A report from analysts at Jefferies suggested that new screenings for metachromatic leukodystrophy and Duchenne muscular dystrophy could bump sales of the gene therapy Libmeldy by more than $100 million.
Kyowa Kirin Could Get Windfall From Updated Newborn Screening Recommendations Read More »
After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26.
Cytokinetics’ Moment of Truth: Can Aficamten Take On BMS in Hypertrophic Cardiomyopathy? Read More »
BioMarin Pharmaceutical has faced a rocky road, promising and then backing off revenue targets and cutting assets that have underperformed. But Amicus’ rare disease portfolio is already bringing in $600 million annually.
BioMarin Pumps Up Revenue Goals With $4.8B Amicus Purchase Read More »
Insmed pointed to a strong placebo response as the reason for the trial’s failure.
With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.
Takeda’s $4B Nimbus Bet Pays Off With ‘Best-in-Class’ Phase III Plaque Psoriasis Data Read More »
The fatalities were attributed to interstitial lung disease, a known side effect of Daiichi Sankyo’s DXd-based antibody-drug conjugates. A spokesperson declined to say how many patients died.
Patient Deaths Put Merck, Daiichi Sankyo’s Antibody-Drug Conjugate on Hold Read More »
Un demoledor informe demuestra que la nicotina es tóxica para el corazón y para los vasos sanguíneos no solo cuando se consume a través de cigarrillo sino también cuando se consume mediante shisha, vapeador o bolsita. El informe recopila y resume los resul …
La nicotina es tóxica en todas las formas de consumirla Read More »
Unos científicos se han topado con un planeta de un tipo nunca antes visto y cuya composición atmosférica desafía todo lo que se sabe acerca de la formación de planetas. Oficialmente llamado PSR J2322-2650b, este extraño mundo con forma de lim&oacut …
Las colisiones de partículas en el LHC (Large Hadron Collider, o Gran Colisionador de Hadrones) pueden alcanzar temperaturas cien mil veces superiores a las del centro del Sol. Sin embargo, de alguna manera, los núcleos de átomos ligeros y sus homólogos de antimateria eme …
Resuelven un enigma sobre la cohesión de la materia Read More »
