Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

Johnson & Johnson Announces Landmark TREMFYA Data: 80% of Patients Achieve Sustained Clinical Remission in Ulcerative Colitis Through 3 Years

JohnsonAndJohnson

Johnson & Johnson announces groundbreaking long-term clinical data revealing that TREMFYA (guselkumab) maintains sustained clinical, endoscopic, and histologic remission in adults with moderately to severely active ulcerative colitis through 3 years of treatment. The QUASAR long-term extension study demonstrates 80.8% clinical remission and 78.6% mucosal healing rates, setting new standards for inflammatory bowel disease management.

Regulatory Approval News Oncology

U.S. FDA Approves Venclexta and Acalabrutinib Combination for First-Line CLL Treatment

AbbVie

On February 20, 2026, the U.S. FDA approved the combination of Venclexta (venetoclax) and acalabrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This landmark decision establishes the first and only all-oral, fixed-duration (time-limited) regimen for previously untreated patients, offering a significant alternative to continuous therapy or chemoimmunotherapy

Business CRO Healthcare & Pharmaceuticals News

Charles River Laboratories 2025 Earnings: Full-Year Revenue of $4.02 Billion with Strategic Growth Initiatives

Charles_River_Laboratories news and statistics

Charles River Laboratories reported 2025 full-year revenue of $4.02 billion, down 0.9% from 2024, with non-GAAP earnings per share of $10.28. The company faced headwinds in its Discovery and Safety Assessment and Manufacturing segments, though Q4 bookings showed substantial improvement, signaling stabilization in the biopharmaceutical market. CEO James C. Foster stated the company is “cautiously optimistic” about 2026, expecting organic revenue growth in the second half of the year. For 2026, management projects non-GAAP EPS of $10.70-$11.20, representing 4-9% growth, driven by cost savings from restructuring initiatives and a lower tax rate. Strategic acquisitions and operational efficiency improvements remain core to the company’s growth strategy.

Clinical Trials News Oncology

Pfizer’s BRAFTOVI Regimen Demonstrates Significant Progression-Free Survival Benefit in Advanced Colorectal Cancer

pfizer news

Pfizer announced positive progression-free survival results from BREAKWATER trial Cohort 3, showing BRAFTOVI combined with cetuximab and FOLFIRI achieves statistically significant and clinically meaningful progression-free survival improvement compared to chemotherapy alone in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

FDA Approves Monthly Dosing for J&J’s Rybrevant Faspro, Marking a New Era in Lung Cancer Treatment

JohnsonAndJohnson

FDA approves a new simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE (lazertinib) for first-line treatment of EGFR-mutated advanced non-small cell lung cancer. The approval allows patients to transition to monthly injections as early as Week 5, significantly reducing clinic visits while maintaining consistent efficacy with the previously approved bi-weekly schedule. PALOMA-2 trial data demonstrated high objective response rates and a fivefold reduction in administration-related reactions compared to intravenous delivery.

Clinical Trials Healthcare & Pharmaceuticals News

Lilly’s Retevmo Shows Substantial Survival Benefit in Early-Stage Lung Cancer Trial

Eli Lilly and Company

Eli Lilly’s Retevmo (selpercatinib) has shown promising results as an adjuvant therapy for early-stage lung cancer. The Phase 3 LIBRETTO-432 trial revealed that Retevmo adjuvant therapy significantly reduced the risk of disease recurrence or death in patients with RET fusion-positive non-small cell lung cancer (NSCLC), marking a breakthrough for this rare molecular subtype affecting 1-2% of lung cancer cases.

Clinical Trials Autoimmune Diseases News

Roche’s Gazyva/Gazyvaro Achieves Positive Phase III Results in Primary Membranous Nephropathy, Marking Historic Milestone for Autoimmune Kidney Disease Treatment

Roche

In a landmark announcement, Roche revealed that Gazyva (obinutuzumab) met its primary endpoint in the phase III MAJESTY trial for primary membranous nephropathy treatment. The trial data demonstrates superior clinical outcomes compared to tacrolimus, positioning Gazyva as a transformative therapy for patients with this chronic autoimmune kidney condition. With nearly 88,000 affected patients in the EU and over 96,000 in the US, primary membranous nephropathy represents a significant unmet medical need. Gazyva phase III results show the potential to become the first FDA and EMA-approved therapy specifically for this indication. The positive MAJESTY trial outcomes highlight Gazyva’s mechanism deep tissue B cell depletion via anti-CD20 targeting as an effective approach to halting disease progression and preserving kidney function in primary membranous nephropathy patients.