Category: News

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.

Regulatory Approval Autoimmune Diseases Healthcare & Pharmaceuticals News

Johnson & Johnson’s Imaavy Wins European Commission Approval for Generalized Myasthenia Gravis

JohnsonAndJohnson

Johnson & Johnson has secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.

Healthcare & Pharmaceuticals Anti-obesity Drugs Business News Weight-loss Drugs

Eli Lilly Cuts Zepbound Prices for Self-Pay Patients Following White House Deal

Eli Lilly and Company

In a major move to improve affordability and counter the compounded drug market, Eli Lilly has cut the monthly cost of Zepbound to $299 for the starter dose. Available exclusively through LillyDirect, these new single-dose vials offer a significant discount for patients without insurance coverage. Read the full details on the new pricing structure and how it impacts the weight-loss drug market.

Regulatory Approval Healthcare & Pharmaceuticals News

Novartis Receives FDA Approval for Itvisma, Expanding Gene Therapy to Older Children and Adults with SMA

novartis

Novartis has secured FDA approval for Itvisma (onasemnogene abeparvovec-brve), marking a historic milestone as the first gene replacement therapy for spinal muscular atrophy (SMA) available to children aged two and older, teens, and adults. This one-time intrathecal injection offers a “game-changing” new treatment option for patients previously ineligible for gene therapy.