Postmarket research

According to Jake Van Naarden, president of Lilly Oncology, the excess deaths could be due to the high rate of crossover in BRUIN CLL-321.
Vertex unveiled long-term durability data for Casgevy, while Beam presented Phase I/II findings for its investigational base editor BEAM-101, building up to a BLA by late 2026.
SURMOUNT-5’s results reflect those of multiple real-world studies, which have found that tirzepatide treatment results in stronger weight loss than semaglutide.
The cancers were diagnosed 19 to 92 months after Skysona treatment.
A Reuters report on Friday revealed that FDA researchers have found additional molecular evidence tying blockbuster asthma therapy montelukast to adverse neuropsychiatric effects.
While the regulator has not approved their use in type 1 diabetes, off-label prescribing for GLP-1 receptor agonists has sharply increased, according to researchers, who warn about the risk of serious side effects such as ketoacidosis.
Real-world evidence show that GSK and ViiV Healthcare’s long-acting pre-exposure prophylaxis Apretude can prevent nearly all HIV infections, while rival Gilead Sciences is moving quickly toward an approval for a twice-yearly option.
The pediatric patients, with a rare neurodegenerative disease, were treated with bluebird bio’s Skysona to slow the progression of neurologic dysfunction. Six patients developed myelodysplastic syndrome and one patient developed acute myeloid leukemia.
While a JAMA study found a decline in mpox antibody responses after vaccination, a University of Oxford expert cautioned that there is still not enough evidence to determine if this decline also leads to waning protections.
Based on new safety signals, Pfizer on Wednesday announced that Oxbryta’s overall benefit “no longer outweighs the risk” in patients with sickle cell disease. Guggenheim Securities analysts said the setback increases investor frustrations with the company’s business development track record.
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