tldrdailynews.com logo
Tag

Amgen

All articles tagged with #amgen

Lp(a) Hypthesis Survives HORIZON Trial Failure as Pipeline Drugs Show Stronger Reductions
health-and-medicine2 days ago

Lp(a) Hypthesis Survives HORIZON Trial Failure as Pipeline Drugs Show Stronger Reductions

The disappointing results of the Lp(a)HORIZON trial, which showed that the drug pelacarsen did not reduce major cardiovascular events despite lowering lipoprotein(a) levels, have not ended the search for Lp(a)-targeted therapies. Experts argue that differences in drug potency and trial design mean that other phase 3 trials, such as Amgen’s OCEAN(a) and Eli Lilly’s ACCLAIM-Lp(a), may still succeed. While pelacarsen reduced Lp(a) by 80%, newer small interfering RNA therapies achieve reductions exceeding 90%. Although the HORIZON failure raises questions about whether Lp(a) is a viable treatment target or merely a risk marker, clinicians emphasize that Lp(a) remains a crucial diagnostic tool for assessing cardiovascular risk.

via Medscape|
#amgen#cardiovascular-disease#clinical-trials
Novartis setback reshapes the Lp(a) drug race as Amgen and Lilly press on
business1 month ago

Novartis setback reshapes the Lp(a) drug race as Amgen and Lilly press on

Novartis disclosed that pelacarsen failed to produce a meaningful reduction in cardiovascular events in a late‑stage trial, despite lowering lipoprotein(a). The miss raises questions about the Lp(a) race but analysts say the hypothesis is weakened, not disproven, and more data are needed to determine if deeper Lp(a) lowering can reduce heart attacks and strokes. The news weighed on Novartis stock and trimmed bets on Amgen and Ionis, while Amgen’s olpasiran and Lilly’s lepodisiran face varied read‑throughs as other players continue to pursue a potential multi‑billion‑dollar market.

via CNBC|
#amgen#business#eli-lilly
Amgen shifts focus to MariTide as AMG 513 is scrapped
business2 months ago

Amgen shifts focus to MariTide as AMG 513 is scrapped

Amgen ended development of its phase 1 obesity drug AMG 513, while continuing the trial for patients already enrolled, and pivoted its obesity strategy to MariTide, a phase 3 antibody–peptide conjugate intended to activate the GLP-1 receptor and inhibit GIPR with a likely four to six doses per year. The company previously faced an FDA hold on AMG 513 and also scrapped AMG 786; MariTide now anchors Amgen’s near‑term obesity program, with weight‑loss readouts expected next year alongside broader studies of cardiovascular risk, type 2 diabetes and sleep apnea. Preclinical obesity assets and other mechanisms remain under exploration.

via Fierce Biotech|
#amgen#business#gipr
FDA tests real-time clinical-trial reviews to speed approvals
technology5 months ago

FDA tests real-time clinical-trial reviews to speed approvals

The FDA announced a pilot to let reviewers access safety and efficacy signals from ongoing clinical trials in real time via a cloud platform, with AstraZeneca and Amgen participating, aiming to cut development time and speed regulatory decisions without replacing traditional sponsor meetings. A parallel AI pilot to optimize early trials is planned, and public comments are invited, all while safeguarding patient privacy.

via Fierce Biotech|
#ai#amgen#astrazeneca
Amgen keeps Tavneos on market as regulators review trial data and safety
business8 months ago

Amgen keeps Tavneos on market as regulators review trial data and safety

Amgen says it will not voluntarily withdraw Tavneos after an FDA request and will continue talks with regulators, even as the EMA re-examines Tavneos data integrity. The FDA is reviewing the original ChemoCentryx trial data and the drug’s risk-benefit profile due to rare hepatotoxicity, while Amgen asserts the underlying data are sound. Tavneos, approved in 2021 in the US and 2022 in the EU, remains a small but growing part of Amgen’s portfolio as it pursues milestones for other drugs like Uplizna and guides 2026 revenue higher after a 2025 showing of about $36.7B.

via Fierce Pharma|
#amgen#business#data-integrity