FierceBiotech

Amgen advances toward lupus redemption while gastric cancer candidate struggles

Amgen’s bad luck in lupus may finally be coming to an end. Daxdilimab, a monoclonal antibody acquired from Horizon Therapeutics in 2023, hit the primary endpoint in a phase 2 trial for discoid lupus ...
Medscape

SIGLEC-1 Tracks Response to Anifrolumab in Lupus Erythematosus, Study Reports

In a prospective pilot study of patients with cutaneous or systemic lupus erythematosus (LE), SIGLEC-1 expression correlated with disease activity and type I interferon (IFN-I) gene scores and ...
Lupus Foundation of America

New study finds anti-CD19 CAR-T therapy, Zorpo-cel, safe and effective treatment for people with systemic lupus erythematosus

A new study exploring the investigational therapy, Zorpo-cel, met its primary safety and secondary efficacy endpoints in people with progressive and treatment-resistant systemic sclerosis (SSc), ...
Lupus Foundation of America

Update: Self-administered Saphnelo remains under FDA review in the U.S.

In the 52-week study, 56.2% of study participants receiving Saphnelo experienced a significant reduction in lupus disease activity at week 52 compared to 37.1% of participants who received the placebo ...
Wall Street Journal

AstraZeneca’s Initial Application for Lupus Injection Turned Down by FDA

AstraZeneca AZN1.42%increase; green up pointing triangle said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with ...
Healio

TULIP-SC: Subcutaneous anifrolumab bests placebo in multiple lupus outcomes at 52 weeks

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Subcutaneous anifrolumab improved over placebo in BICLA ...
Bloomberg L.P.

FDA Rejects Self-Injected Version of Astra’s Lupus Drug

The US Food and Drug Administration turned down a self-administered version of AstraZeneca Plc’s lupus medicine, but the UK drugmaker said it’s still working with regulators to advance the request.
Yahoo

US FDA rejects AstraZeneca's easy-to-use version of lupus drug Saphnelo

Add Yahoo as a preferred source to see more of our stories on Google. A company logo is seen at the AstraZeneca site in Macclesfield, Britain, May 11, 2021. REUTERS/Phil Noble Feb 3 (Reuters) - ...
Reuters

US FDA rejects AstraZeneca's easier-to-use version of lupus therapy

US FDA rejects AstraZeneca's subcutaneous Saphnelo AstraZeneca to keep working with FDA on application Shares in AstraZeneca fall by more than 1.5% Feb 3 (Reuters) - AstraZeneca (AZN.L), opens new tab ...
FiercePharma

FDA rejects AZ's subQ Saphnelo, but company expects quick turnaround for new approval decision

AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version of lupus treatment Saphnelo. The FDA has sent the British drugmaker a ...
Morningstar

AstraZeneca's Initial Application for Lupus Injection Turned Down by FDA

AstraZeneca said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with the regulator to move forward with an ...
Nature

Exercise rewires the brain — boosting the body’s endurance

Exercise pumps up your muscles — but it might also be pumping up your neurons. According to a study published today in Neuron 1, repeated exercise sessions on a treadmill strengthen the wiring in a ...