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Vaccine R&D

Medical Associations Sue RFK Jr. Over COVID-19 Vaccine Guideline Rollbacks

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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.

Pharma M&A Reignites in June, Signaling Renewed Momentum Despite Regulatory Headwinds

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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

FDA Grants Surge of Regulatory Approvals Across RSV, Cancer, and Hepatitis C Therapeutics in June 2025

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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.

Roche’s Fenebrutinib Shows Sustained Efficacy in Multiple Sclerosis Over 96 Weeks

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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.

CHMP Recommends EU Approval of Roche’s Itovebi for Advanced Breast Cancer Treatment

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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.

Columvi Combination Shows Promising Survival Benefit in Aggressive Lymphoma as FDA Review Progresses

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SHERIDAN, WYOMING – May 27, 2025 – Roche has announced an encouraging update on its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx), following discussion by the FDA’s Oncologic Drugs Advisory Committee (ODAC). The combination therapy demonstrated a significant 41% reduction in the risk of death in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for autologous stem cell transplant.