Dive Brief: The Food and Drug Administration on Monday approved a new vaccine from Merck & Co. that protects against 21 types of the bacteria that causes pneumococcal disease. The vaccine, cleared for use in adults 18 and older, will be sold by Merck as Capvaxive. Pneumococcal disease can lead to severe infection in the…
Dive Brief: An experimental pill developed by Takeda to treat the rare epilepsies Dravet and Lennox-Gastaut syndromes missed the main goals of two Phase 3 trials, failing to reduce the frequency of seizures after four months of treatment, the company said Monday. Takeda said the drug, called soticlestat, helped on some secondary effectiveness measures in…
The advent of liquid biopsy, especially using targeted RNA sequencing from cell-free RNA in body fluids, is transforming cancer research. This minimally invasive approach significantly enhances cancer management at various stages, from early detection to therapy selection and disease monitoring. Incorporating this method into clinical trials and research has profound implications. It offers precise gene…
AbbVie is securing its place in an emerging gastrointestinal disease drug field, paying China-based FutureGen Biopharmaceutical $150 million in immediate and near-term fees for rights to an antibody drug targeting TL1A, a molecule linked to heightened immune responses in inflammatory bowel disease. The Illinois-based drugmaker is following rivals like Merck, Roche, Teva and Sanofi, which…
Dive Brief: Moderna said its next-generation COVID-19 vaccine succeeded in a Phase 3 study, offering increased effectiveness for adults. The vaccine, known as mRNA-1283, is designed to fight newer strains of coronavirus that have emerged since the development of Moderna’s original shot, Spikevax. Overall, the trial found the new version works at least as well as…
The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a high-profile court battle. Justices held that the plaintiffs’ “desire to make a drug less available to others” did not give…
Precision immunology has emerged as one of the hottest fields in drugmaking over the past several years, spurred by new ways to make more potent drugs that don’t trigger as many side effects. Large drugmakers and venture firms alike have shelled out billions of dollars for promising anti-inflammatory treatments. Johnson & Johnson and Roche both…
Pfizer’s experimental gene therapy for Duchenne muscular dystrophy didn’t improve the motor function of young boys enrolled in a late-stage trial meant to provide a decisive verdict on the treatment’s potential. Results from a final analysis showed the treatment failed to meet the main and secondary goals of the study compared to placebo, the company…
Dive Brief: The Food and Drug Administration on Monday cleared a new treatment option for the rare liver disease primary biliary cholangitis, granting an accelerated approval to Ipsen’s drug Iqirvo. The agency’s OK was based on clinical trial data showing treatment with Iqirvo improved certain biochemical markers for cholestasis, or the accumulation in the liver…
Approval of Eli Lilly’s experimental Alzheimer’s disease drug donanemab would help drive sales of Eisai and Biogen’s rival medicine Leqembi, analysts wrote after a Food and Drug Administration panel on Monday supported clearance of donanemab. “A rising tide lifts all boats, in our view,” wrote Myles Minter, an analyst at William Blair, in a client…
