Vaccine R&D

SHERIDAN, WYOMING – August 12, 2025 – The Department of Health and Human Services (HHS) is facing fresh turbulence after the abrupt dismissal of Gray Delany, the lead implementor of the Make America Healthy Again (MAHA) initiative. The move comes just days after Health Secretary Robert F. Kennedy Jr. terminated 22 mRNA vaccine contracts worth a combined $500 million, triggering intense debate across the biomedical and public health sectors.

SHERIDAN, WYOMING – August 11, 2025 – The U.S. pharmaceutical sector faces a pivotal moment as recent federal funding cuts to mRNA vaccine programs threaten to slow one of oncology’s most promising frontiers: dendritic cell–based mRNA cancer immunotherapies. With the Department of Health and Human Services ending approximately $500 million in BARDA contracts, industry stakeholders are being called upon to bridge the gap and accelerate clinical translation.

Why mRNA Technology Is Critical for Cancer Immunotherapy

SHERIDAN, WYOMING – August 10, 2025 – In a rapid reversal, Dr. Vinay Prasad has resumed leadership of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) less than two weeks after stepping down. The reinstatement, confirmed by the Department of Health and Human Services (HHS), ends speculation over the agency’s direction during a critical period for advanced biologics oversight.

FDA Leadership Transition Reverses Course

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 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 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 1, 2025 – A late surge of acquisitions in June has reenergized pharmaceutical M&A activity, with six major deals announced that propelled first-half 2025 totals to 32 transactions across the industry. This burst of dealmaking, highlighted by BioNTech’s $1.25 billion acquisition of CureVac and Eli Lilly’s $1.3 billion buyout of Verve Therapeutics, has analysts optimistic that the sector’s cautious stance may finally be easing.

Resilient M&A Amid Regulatory Uncertainty

SHERIDAN, WYOMING – July 1, 2025 – A wave of pivotal FDA decisions in June 2025 is reshaping key segments of the pharmaceutical landscape, with new approvals spanning respiratory syncytial virus (RSV) vaccines, advanced cancer treatments, and the first-ever antiviral for acute hepatitis C. These regulatory moves not only expand therapeutic options for patients but also set the stage for intensified competition in critical markets, underscoring strategic opportunities for companies across the biopharmaceutical sector.

SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling new data from its ongoing FENopta open-label extension study, confirming that its investigational therapy fenebrutinib continues to provide sustained disease suppression in patients with relapsing multiple sclerosis (RMS) for up to two years.

SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.