SHERIDAN, WYOMING – July 21, 2025 – GlaxoSmithKline’s ambitions to relaunch its antibody-drug conjugate Blenrep for multiple myeloma treatment faced a critical blow last Thursday, as the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) rejected two proposed combination therapies over persistent safety and dosing concerns.
Safety Risks and Dosing Shortfalls Undermine Confidence
SHERIDAN, WYOMING – July 21, 2025 – Sarepta Therapeutics has taken bold steps to reshape its business, unveiling a sweeping organizational overhaul that includes significant workforce reductions, a strategic pipeline pivot, and a new safety warning on its flagship gene therapy product. The move, announced late Wednesday, is positioning the company for long-term resilience — a shift that has already caught the attention of analysts and investors alike.
Strategic Restructuring Targets Operational Focus
SHERIDAN, WYOMING – July 21, 2025 – Novartis is intensifying its strategic push to relocate key drug manufacturing operations to the United States, aiming to safeguard its U.S. market position against potential tariff impacts. In its second-quarter earnings call last Thursday, CEO Vas Narasimhan emphasized the urgency of reshoring production, while acknowledging the complexity of fully transitioning manufacturing operations.
Novartis Targets Full U.S. Production for Key Medicines
SHERIDAN, WYOMING – July 12, 2025 – Moderna has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years who are at higher risk of contracting the disease, reinforcing the company’s position as a key innovator in the mRNA vaccine space.
Spikevax, which had previously been available to children only under an emergency use authorization, is now fully approved for:
SHERIDAN, WYOMING – July 12, 2025 – A landmark release of 200 complete response letters (CRLs) by the U.S. Food and Drug Administration (FDA) has unveiled a decade of regulatory decisions behind once-rejected therapies, now approved and on the market. Among the most revealing cases are Eli Lilly’s Alzheimer’s treatment Kisunla, Sarepta’s Duchenne muscular dystrophy drug Vyondys 53, and Gilead’s long-acting HIV therapy Sunlenca.
SHERIDAN, WYOMING – July 8, 2025 – A coalition of major U.S. medical societies has filed a federal lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr., challenging his directive to remove COVID-19 vaccines from routine immunization schedules for healthy children and pregnant women.
SHERIDAN, WYOMING – July 8, 2025 – The newly signed One Big Beautiful Bill from President Donald Trump is poised to reshape the U.S. pharmaceutical policy landscape, restoring expanded orphan drug exemptions from the Inflation Reduction Act (IRA) while introducing significant Medicaid cuts and dropping regulatory reforms on pharmacy benefit managers (PBMs). The bill signals a strategic shift that may benefit the biopharma sector, while raising concerns about access and affordability in public healthcare.
SHERIDAN, WYOMING – July 8, 2025 – BrainStorm Cell Therapeutics is once again at the center of the amyotrophic lateral sclerosis (ALS) treatment debate as patients formally petition the FDA to reconsider the approval of its investigational stem cell therapy, NurOwn. Citing new survival data and expanded access outcomes, the Citizens’ Petition seeks regulatory reassessment of the once-rejected therapy, underscoring the shifting landscape of ALS drug development and patient advocacy.
Renewed Push for Regulatory Reevaluation
SHERIDAN, WYOMING – July 8, 2025 – Regeneron has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody linvoseltamab, now branded as Lynozyfic, for the treatment of patients with relapsed or refractory multiple myeloma—unlocking a market potential estimated at $600 million.
SHERIDAN, WYOMING – July 8, 2025 – In a landmark agreement that underscores the growing convergence of artificial intelligence and drug discovery, Tokyo-based Chugai Pharmaceutical has entered into a multi-phase research collaboration with Singapore-headquartered biotech Gero to target age-related diseases using AI-driven insights. The deal could exceed $1 billion in total value, positioning both companies at the forefront of longevity-focused pharmaceutical innovation.
AI-Powered Discovery for High-Impact Biologics