Category: Healthcare & Pharmaceuticals

Clinical Trials Healthcare & Pharmaceuticals News

AstraZeneca’s Gefurulimab Shows Major Promise in Late-Stage Myasthenia Gravis Trial

AstraZeneca

AstraZeneca announced that its novel nanobody, gefurulimab, has successfully met its primary and all secondary endpoints in the PREVAIL Phase III trial for adults with generalized myasthenia gravis (gMG). The results showed that the once-weekly, self-administered treatment delivered statistically significant and clinically meaningful improvements in daily living activities for patients with this rare autoimmune disease.

Regulatory Approval Healthcare & Pharmaceuticals

European Commission Approves DARZALEX® for Treating High-Risk Smouldering Multiple Myeloma

JohnsonAndJohnson

The European Commission (EC) has granted a landmark approval for Johnson & Johnson’s DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma (SMM). This decision marks a significant shift in the treatment paradigm for this precursor to active multiple myeloma, moving away from the traditional “watch and wait” approach to proactive, early therapeutic intervention.

Clinical Trials Healthcare & Pharmaceuticals News

New Study Shows 87% Reduction in RSV-Related Doctor Visits for Infants Treated with Sanofi’s BEYFORTUS®

sanofi

A groundbreaking real-world study has revealed that Beyfortus (nirsevimab-alip) significantly reduces the incidence of respiratory syncytial virus (RSV) disease in infants. The largest of its kind in the United States, the study demonstrated an 87% reduction in RSV cases requiring a visit to a doctor or hospital and a 98% decrease in hospitalizations among infants who received the treatment.

Regulatory News

FDA Rejects Genentech’s Bid to Expand Use of Lymphoma Drug Columvi

Roche

Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Business Healthcare & Pharmaceuticals News

Johnson & Johnson Beats Q2 Estimates, Raises 2025 Outlook on Strong Sales Growth

JohnsonAndJohnson

Johnson & Johnson announced robust second-quarter 2025 financial results, surpassing analyst expectations and raising its full-year guidance. The healthcare giant reported a significant 5.8% increase in sales to $23.7 billion, driven by strong performances in its Innovative Medicine and MedTech segments.

Clinical Trials Healthcare & Pharmaceuticals News

Gilead Unveils Promising New Data on Twice-Yearly HIV Prevention Drug Lenacapavir

Gilead

A key takeaway from the presentation is the strong preference for the twice-yearly injection over daily oral medication among trial participants. Over 75% of those surveyed expressed a preference for the injectable option, citing increased confidence in their protection against HIV and a lower risk of missing a dose.

Regulatory Approval News

FDA Approves Updated Label for Lilly’s Alzheimer’s Drug Kisunla (donanemab-azbt), Offering a Safer Dosing Schedule

Eli Lilly and Company

The U.S. Food and Drug Administration (FDA) has officially approved an updated label for Eli Lilly’s groundbreaking Alzheimer’s drug, Kisunla (donanemab-azbt). This significant update introduces a new, more gradual dosing schedule specifically designed to enhance patient safety by reducing the risk of amyloid-related imaging abnormalities (ARIA), a critical side effect.