Clinical Trials Healthcare & Pharmaceuticals News

Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial

Gilead

Gilead has announced positive Phase 3 results for its investigational single-tablet regimen (STR) of bictegravir and lenacapavir (BIC/LEN) in the ARTISTRY-2 trial. The new combination met its primary endpoint, demonstrating non-inferiority to BIKTARVY in maintaining viral suppression in adults with HIV-1. This novel two-drug regimen combines the potent integrase inhibitor bictegravir with the first-in-class capsid inhibitor lenacapavir, representing a potential new, simplified treatment option for long-term HIV management.

Regulatory Autoimmune Diseases Healthcare & Pharmaceuticals News

Sanofi Anticipates Delay in FDA Regulatory Decision for Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis

sanofi

Sanofi anticipates that the US regulatory decision for its investigational drug, tolebrutinib, for non-relapsing secondary progressive multiple sclerosis (nrSPMS) will be delayed beyond the previous December 2025 target action date, with further guidance expected by the end of Q1 2026.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Approves AKEEGA®, the First Precision Therapy for BRCA2-Mutated Metastatic Prostate Cancer, Slashing Disease Progression Risk by 54%

JohnsonAndJohnson

A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.

Regulatory Approval Autoimmune Diseases News

U.S. FDA Approves Amgen’s UPLIZNA® for Generalized Myasthenia Gravis in Adults

amgen

The FDA has approved Amgen’s UPLIZNA for adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. UPLIZNA is the first and only CD19-targeted B-cell therapy approved for this indication, offering a convenient dosing schedule of just two maintenance doses per year following the initial loading regimen. The approval is based on strong efficacy data from the Phase 3 MINT trial.

Clinical Trials Healthcare & Pharmaceuticals News

Lilly’s Triple-Agonist Retatrutide Delivers Unprecedented Weight Loss, Dramatically Reduces Osteoarthritis Pain in Phase 3 Trial

Eli Lilly and Company

Eli Lilly and Company announced groundbreaking positive topline results from the Phase 3 TRIUMPH-4 clinical trial, confirming its investigational triple-agonist drug, retatrutide, delivered unprecedented weight loss of up to 28.7% (71.2 lbs) and substantial relief from the pain and functional limitations associated with knee osteoarthritis.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Lilly’s Jaypirca Outperforms Imbruvica in Landmark Phase 3 Trial for CLL/SLL

Eli Lilly and Company

Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Grants Full Approval to Lilly’s Jaypirca® for Expanded Use in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Eli Lilly and Company

U.S. FDA has granted full approval to Eli Lilly’s Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This expanded indication allows the use of the non-covalent BTK inhibitor immediately following prior covalent BTK inhibitor therapy. The decision is bolstered by data from the Phase 3 BRUIN CLL-321 trial, which demonstrated a statistically significant improvement in progression-free survival compared to standard combinatorial therapies.