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Clinical Trial News

ACIP Members Face Termination as RFK Jr.'s Vaccine Policy Changes Spark Institutional Upheaval

  • Four members of the CDC's Advisory Committee on Immunization Practices have received termination notices as special government employees, raising concerns about potential political interference in vaccine policy oversight.
  • The terminations follow the resignation of ACIP co-lead Lakshmi Panagiotakopoulos, who stepped down after HHS Secretary Robert F. Kennedy Jr. bypassed traditional protocols to change COVID-19 vaccine recommendations without committee input.
  • Industry analysts had previously warned that Kennedy could "restack" the ACIP panel with members aligned with anti-vaccine rhetoric to redirect public health policies.
  • The institutional changes are occurring amid a leadership vacuum at the CDC, with no confirmed director in place since February and Trump's new nominee still awaiting a confirmation hearing.

High Placebo Response Rates Challenge Lupus Drug Development as Researchers Develop New Trial Strategies

Monoclonal Antibody
  • High placebo response rates of approximately 40% in systemic lupus erythematosus trials are obscuring the true efficacy of investigational biologics, as patients continue receiving powerful background medications like glucocorticoids and hydroxychloroquine.
  • Researchers have identified four core strategies to address the "placebo problem," including stabilizing background therapy, applying central expert review, controlling rescue therapy, and acknowledging evolving standard-of-care treatments.
  • New trial design innovations include enriching study populations with high-disease-activity patients, employing more stringent sustained endpoints, and implementing adaptive features to better detect drug efficacy signals.
  • Clinical practice approaches now focus on realistic patient expectations for biologics like belimumab and anifrolumab, emphasizing gradual benefit timelines of 3-4 months and steroid-sparing goals rather than miracle cures.

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

NCT00137969CompletedPhase 2
Genentech, Inc.
Posted 5/10/2005

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

NCT00424476CompletedPhase 3
Human Genome Sciences Inc.
Posted 5/1/2007

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

NCT01649765Active, Not RecruitingPhase 2
GlaxoSmithKline
Posted 9/7/2012

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

NCT00410384CompletedPhase 3
Human Genome Sciences Inc.
Posted 12/1/2006

Mission Bio Secures Funding to Advance Single-Cell Tri-Omics Platform for Cancer Drug Development

Precision MedicineCAR-T
  • Mission Bio completed equity financing led by Ally Bridge Group to accelerate commercial growth and advance its Tapestri Platform's single-cell tri-omics capabilities for cancer research.
  • The company launched its industry-first Single-Cell Genotype and Targeted Gene Expression assay, enabling simultaneous profiling of DNA and RNA from over 10,000 single cells to address clinical trial failures.
  • The funding will support commercial expansion, development of tri-omics capabilities combining DNA, RNA, and protein analysis, and accelerated clinical adoption across multiple cancer segments including multiple myeloma and CAR-T therapies.

First Ascent Biomedical Partners with Fight Colorectal Cancer for $350,000 Precision Medicine Study

Precision MedicineAI
  • First Ascent Biomedical and Fight Colorectal Cancer have launched a $350,000 prospective feasibility study to advance precision oncology for colorectal cancer patients using xDRIVE tumor profiling technology.
  • The study will enroll 25 patients with metastatic colorectal cancer in Minnesota, integrating functional drug testing, genetic analysis, and artificial intelligence to provide personalized treatment insights.
  • Led by gastrointestinal cancer specialist Dr. Hao Xie and principal investigator Dr. Noah Berlow, the study aims to complete enrollment within nine months and deliver actionable data to oncologists.
  • The collaboration represents a strategic focus on enhancing care for patients with limited treatment options through advanced research and rapid, individualized tumor profiling.

Church & Dwight Recalls Zicam and Orajel Nasal Swabs Due to Fungal Contamination Risk

  • Church & Dwight Co., Inc. has issued a voluntary nationwide recall of all lots within expiry of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs due to potential fungal contamination in cotton swab components.
  • The contaminated swabs pose significant health risks including serious and life-threatening blood infections, particularly for children and individuals with compromised immune systems or underlying medical conditions.
  • No serious adverse events have been reported to date, but consumers are advised to stop using the products immediately and contact the company for full refunds.
  • The recall affects products distributed nationwide in the United States and Puerto Rico, while other Zicam and Orajel products remain unaffected by this safety action.

Neoadjuvant Immunotherapy Plus Chemotherapy Improves Long-Term Survival in Operable NSCLC

  • Adding immunotherapy to chemotherapy before surgery for patients with operable non-small cell lung cancer improved long-term survival overall compared with chemotherapy alone.
  • The clinical trial results were published June 2 in The New England Journal of Medicine and presented at the annual meeting of the American Society of Clinical Oncology.
  • This neoadjuvant approach represents a significant advancement in the treatment of operable NSCLC, offering patients better long-term outcomes through preoperative combination therapy.

Powers Health Partners with Profound Research to Establish Clinical Research Center in Northwest Indiana

  • Powers Health announces a strategic partnership with Profound Research to launch a clinical research center, initially focusing on cardiology, gastroenterology, and neurology specialties.
  • The collaboration will embed clinical research operations at select Powers Health locations, allowing patients to participate in trials directly through their trusted physicians.
  • This partnership aims to remove barriers to clinical trial access and accelerate care options for the Northwest Indiana community.
  • The first studies are expected to begin enrolling patients this summer, with plans for expansion into additional specialties and locations.

Novartis Raises Mid-Term Sales Outlook to 6% Growth Through 2029 on Pipeline Strength

Monoclonal Antibody
  • Novartis has increased its mid-term sales growth guidance to 6% or more through 2029, up from previous forecasts, driven by more than 30 high-value pipeline projects.
  • The company expects four upcoming launches to achieve multibillion-dollar peak sales, including oral BTK inhibitor remibrutinib, Lp(a) drug pelacarsen, gene therapy OAV101 IT, and anti-BAFF-R antibody ianalumab.
  • Eight currently marketed medicines have peak sales potential between $3 billion and $8 billion-plus, with raised projections for Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio.
  • More than 15 data readouts expected within the next two years could lead to regulatory filings, supporting the company's focused strategy following the Sandoz spinout.

Nkarta Appoints Immunology Expert Shawn Rose as Chief Medical Officer to Lead Autoimmune NK Cell Therapy Development

  • Nkarta has appointed Shawn Rose, M.D. Ph.D., as Chief Medical Officer and Head of R&D, effective June 23, 2025, replacing David R. Shook who is returning to oncology.
  • Dr. Rose brings extensive immunology expertise, having advanced over a dozen programs from discovery to clinical development and contributed to approved medicines including Sotyktu, Stelara, and Tremfya.
  • The leadership change supports Nkarta's strategic focus on developing allogeneic NK cell therapies for autoimmune diseases, with lead candidate NKX019 targeting CD19-positive B cells.
  • NKX019 is an off-the-shelf CAR-NK cell therapy engineered with IL-15 for enhanced persistence and is being evaluated across multiple autoimmune conditions.

Brenntag Specialties Acquires Czech Firm mcePharma to Expand GMP Capabilities Across EMEA Region

  • Brenntag Specialties has acquired Czech-based mcePharma to strengthen its position in the pharma and biopharma industries through expanded continuous monitoring platform capabilities and strategic presence in central Europe.
  • The acquisition enables Brenntag to develop a central hub for good manufacturing practice value-added services across Europe, the Middle East and Africa, supporting increased demand for customized solutions in the biopharma market.
  • The company announced additional investment at the mcePharma site to scale GMP blending, down-packing and biobuffer production to improve operational efficiency and meet growing needs for high-quality, compliant formulation and distribution services.
  • Existing facilities at mcePharma include advanced GMP infrastructure and over-the-counter product development capacity, which will be integrated into Brenntag's broader life sciences service offering.

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