Regulation & Industry Affairs

SHERIDAN, WYOMING – August 9, 2025 – The cell and gene therapy (CGT) sector stands at a pivotal moment. Once buoyed by multibillion-dollar valuations, companies like Sarepta Therapeutics and bluebird bio have faced sharp declines, underscoring the sector’s commercial growing pains. Industry leaders now agree: sustainable success will depend on advancing manufacturing, aligning global regulations, and better communicating value to payers.

Next-Generation Manufacturing as a Growth Engine

SHERIDAN, WYOMING – August 8, 2025 – A wave of high-value licensing deals between multinational pharmaceutical companies and Chinese biotechs is reshaping the global drug development landscape. While the headlines highlight billion-dollar transactions, the reality on the ground is a complex mix of opportunity and survival for China’s crowded biotech sector.

SHERIDAN, WYOMING – August 8, 2025 – In a move aimed at reducing the nation’s dependence on overseas pharmaceutical production, the U.S. Food and Drug Administration (FDA) has launched PreCheck, a two-phase program designed to speed regulatory review and strengthen domestic drug manufacturing capacity.

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 – The American Medical Association (AMA) has issued a public plea urging Health Secretary Robert F. Kennedy Jr. to preserve the U.S. Preventive Services Task Force (USPSTF), following reports that the panel could be dissolved due to ideological concerns. The potential shakeup, while not yet finalized, has sparked widespread concern across the healthcare community and could significantly impact access to preventive care services nationwide.

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 25, 2025 – Royal Philips (NYSE: PHG, AEX: PHIA) has confirmed the exchange ratio for its 2024 dividend, announcing a share-based conversion rate of one new common share for every 23.6353 existing shares. The ratio was determined based on the volume-weighted average price of Philips shares traded on Euronext Amsterdam across May 30, June 2, and June 3, 2025, which stood at EUR 20.0600.

SHERIDAN, WYOMING – July 25, 2025 – In a significant move reshaping national vaccine policy, the U.S. Department of Health and Human Services (HHS) has announced it will eliminate thimerosal from all influenza vaccines distributed in the United States. The decision follows a unanimous vote by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) on June 26, 2025, and marks the end of an era for a preservative that has been both a practical necessity and a source of public debate for over two decades.

SHERIDAN, WYOMING – July 25, 2025 – Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx). The application sought approval for this regimen as a second-line treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.

SHERIDAN, WYOMING – July 25, 2025 – As Q2 2025 earnings season unfolds, leading biotech firms face scrutiny amid a backdrop of regulatory headwinds, clinical trial disruptions, and evolving commercial strategies. Several key players are poised to reveal performance metrics that could reshape market sentiment across the pharmaceutical innovation landscape.

Sarepta Faces Scrutiny Amid Safety Setbacks and Strategic Pivot