Clinical Trials & CROs

SHERIDAN, WYOMING – July 29, 2025 – Roche’s gene therapy for Duchenne muscular dystrophy (DMD), Elevidys™ (delandistrogene moxeparvovec), has encountered a regulatory hurdle in the European Union, following a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). While disappointing, the decision does not mark the end of the road for the therapy, which remains the first and only disease-modifying gene therapy available for DMD and continues to show promise in stabilizing disease progression in ambulatory patients.

SHERIDAN, WYOMING – July 29, 2025 – Bio-Rad Laboratories has named Rajat Mehta as its new Executive Vice President of Global Commercial Operations, signaling a strategic push to accelerate growth across its diagnostics and life sciences business lines. Mehta, whose appointment takes effect August 4, 2025, brings broad cross-sector expertise and a proven track record of commercial execution in the biopharma and scientific instrumentation industries.

New commercial leadership aimed at scaling global market impact

SHERIDAN, WYOMING – July 29, 2025 – In a swift regulatory reversal, the U.S. Food and Drug Administration (FDA) has lifted its recommendation for a voluntary hold on Sarepta Therapeutics’ gene therapy Elevidys for ambulatory Duchenne muscular dystrophy (DMD) patients—restoring immediate commercial viability for the treatment and stabilizing investor confidence after weeks of uncertainty.

FDA Reinstates Ambulatory Access Following Brief Hold

SHERIDAN, WYOMING – July 29, 2025 – Roche has unveiled compelling early-stage data for its next-generation Alzheimer’s therapy, trontinemab, which demonstrated rapid and deep amyloid plaque clearance in patients after just seven months of treatment. The findings, presented at the 2025 Alzheimer’s Association International Conference in Toronto, suggest a potential leap beyond first-generation FDA-approved antibodies and set the stage for a new class of blood-brain barrier-penetrating biologics.

SHERIDAN, WYOMING – July 29, 2025 – Boehringer Ingelheim has entered a strategic collaboration with Re-Vana Therapeutics, aiming to co-develop long-acting injectable therapies for serious eye diseases using Re-Vana’s proprietary sustained-release delivery platform. The multi-target agreement could exceed $1 billion in total value and marks a significant move by Boehringer into the ophthalmology space.

Pioneering extended-release drug delivery for ophthalmology

SHERIDAN, WYOMING – July 29, 2025 – GSK has launched one of the largest licensing collaborations of the year, partnering with China-based Hengrui Pharma in a deal that could reach up to $12 billion. The multi-program alliance aims to accelerate global development of 12 investigational therapies targeting oncology, respiratory diseases, and immunology — marking a major step in GSK’s bid to diversify and deepen its late-stage pipeline.

A strategic cornerstone: HRS-9821 for COPD

SHERIDAN, WYOMING – July 29, 2025 – Sarepta Therapeutics is once again under regulatory spotlight following the death of an 8-year-old boy in Brazil who had received its gene therapy Elevidys, triggering an FDA investigation and fresh market turbulence for the embattled biotech.

SHERIDAN, WYOMING – July 29, 2025 – As the Alzheimer’s treatment market evolves beyond anti-amyloid antibodies, leading biopharma companies are doubling down on symptomatic therapies to address the daily struggles of patients and caregivers. While breakthrough drugs like Leqembi and Kisunla have changed the landscape with disease-modifying potential, their limitations are propelling renewed interest in managing Alzheimer’s-related psychosis, agitation, and cognitive decline—particularly in mid-to-late-stage patients.

SHERIDAN, WYOMING – July 29, 2025 – As the Alzheimer’s treatment landscape evolves beyond legacy amyloid-targeting approaches, five upcoming trial readouts are expected to deliver pivotal data that could shift both clinical practice and market leadership. From repurposed GLP-1 drugs to precision antibody therapies, leading pharma and biotech players are advancing differentiated strategies to address persistent unmet needs in Alzheimer’s care.

Data Milestones Poised to Shape the Post-Amyloid Era

SHERIDAN, WYOMING – July 29, 2025 – As Q2 earnings season ramps up, a diverse group of biotech leaders—ranging from Sarepta Therapeutics to Vertex Pharmaceuticals—find themselves navigating vastly different strategic terrain. From regulatory setbacks and gene therapy scrutiny to CRISPR approvals and pain therapy innovation, this quarter’s results could redefine investor confidence and reshape R&D roadmaps across the sector.

Sarepta Confronts Regulatory Turbulence and Gene Therapy Fallout