Category: Healthcare & Pharmaceuticals

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.

Healthcare & Pharmaceuticals Business News

GSK Acquires Efimosfermin, Bolstering Liver Disease Pipeline with Potential Best-in-Class Treatment

GSK - GlaxoSmithKline

GSK has finalized its acquisition of efimosfermin, a promising new therapeutic for steatotic liver disease. The deal, valued at up to $2 billion, positions GSK to potentially launch a best-in-class treatment for MASH and ALD by 2029, significantly enhancing its hepatology portfolio.