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…
Dive Brief: Moderna on Monday said a combination flu and COVID-19 shot it’s developing met the goal of a late-stage study, eliciting higher immune responses to the two viruses than did available vaccines when tested among adults 50 years or older. Dubbed mRNA-1083, the shot is made up of Moderna’s second-generation COVID vaccine and a…
An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. On Monday, the panel unanimously voted that the medicine, developed by Eli Lilly and known as donanemab, appears to be an effective treatment for certain…
As healthcare moves toward the shared goal of improving patient care more economically, stakeholders across the healthcare ecosystem are increasingly aligned with the principles of value-based care. Value-based care is a payment model in which healthcare providers are paid for their treatments’ performance and patient outcomes, as opposed to the traditional fee-for-service payment model, in…
Dive Brief: Seres Therapeutics plans to sell all the rights to its microbiome pill to Nestlé Health Science as it struggles to fund operations. Under a nonbinding memorandum of understanding announced Thursday, the Swiss company will acquire all the product and intellectual property rights to Vowst, which was approved in the U.S. in 2023 to…
A group of advisers to the Food and Drug Administration on Wednesday unanimously recommended that COVID-19 vaccines be updated to cover coronavirus strains with a family known as JN.1 ahead of the fall. The committee, which had originally been scheduled to meet in mid-May, supported targeting the JN.1 lineage broadly, rather than some specific subvariants…
After a turbulent few years, 2024 has given the biotechnology industry some signs of a return to normalcy. For one, venture investment appears to have stabilized at levels seen prior to a pandemic-era spike. Data presented by the Biotechnology Innovation Organization at the group’s annual meeting this week in San Diego showed private drug companies…
