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Clinical Trial News

Barriers to Personalized Medicine: Payer Reimbursement Challenges Slow Diagnostic Test Adoption

  • Less than 5% of US private companies currently reimburse for genetic tests, creating a significant barrier to personalized medicine adoption despite its potential to reduce healthcare costs.
  • Studies show personalized medicine diagnostic tests can generate savings between $600-$28,000 per patient, with successful examples like Oncotype DX demonstrating $1,930 savings per patient through reduced chemotherapy needs.
  • Pay-for-performance models are emerging as a potential solution, growing at 26% annually in the US, offering a win-win approach for pharmaceutical companies and payers in personalized medicine implementation.

Advancements in CAR-Modified T Cells for Leukemia Treatment

Recent developments in cellular immunotherapy have introduced CAR-modified T cells targeting the CD19 antigen as a promising strategy for treating B-cell cancers. Despite challenges in clinical trial design and CAR structure, early trials show potential for significant impact on disease progression.

Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT

NCT00840853Active, Not RecruitingPhase 1
Baylor College of Medicine
Posted 4/1/2009

Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia

NCT00995137CompletedPhase 1
St. Jude Children's Research Hospital
Posted 10/1/2009

Consolidation Therapy With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients With Chronic Lymphocytic Leukemia Following Upfront Chemotherapy With Pentostatin, Cyclophosphamide and Rituximab

NCT01416974CompletedPhase 1
Memorial Sloan Kettering Cancer Center
Posted 8/22/2011

Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood

NCT01497184CompletedPhase 1
M.D. Anderson Cancer Center
Posted 12/1/2011

Administration of Anti-CD19-chimeric-antigen-receptor-transduced T Cells From the Original Transplant Donor to Patients With Recurrent or Persistent B-cell Malignancies After Allogeneic Stem Cell Transplantation

NCT01087294CompletedPhase 1
National Cancer Institute (NCI)
Posted 8/4/2010

CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy

NCT01029366CompletedPhase 1
University of Pennsylvania
Posted 3/17/2010

In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies

NCT01430390Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 9/1/2011

Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma

NCT01593696CompletedPhase 1
National Cancer Institute (NCI)
Posted 6/29/2012

Treatment of Relapsed or Chemotherapy Refractory Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma Using Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

NCT00466531Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 3/21/2007

CD19 Chimeric Receptor Expressing T Lymphocytes in B-Cell Non Hodgkin's Lymphoma, ALL & CLL

NCT00586391Active, Not RecruitingPhase 1
Baylor College of Medicine
Posted 2/1/2009

Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

NCT01044069Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 1/5/2010

CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma

NCT00924326CompletedPhase 1
National Cancer Institute (NCI)
Posted 2/17/2009

CD19 CAR T Cells for B Cell Malignancies After Allogeneic Transplant

NCT01475058CompletedPhase 1
Fred Hutchinson Cancer Center
Posted 4/1/2012

Allo CART-19 Protocol

NCT01551043TerminatedPhase 1
University of Pennsylvania
Posted 9/1/2010

CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies

NCT00968760CompletedPhase 1
M.D. Anderson Cancer Center
Posted 6/20/2011

FDA Approves Xarelto for Atrial Fibrillation Treatment

  • The FDA has approved Xarelto (rivaroxaban) for treating atrial fibrillation, a common heart disorder increasing stroke risk.
  • Xarelto, developed by Johnson & Johnson and Bayer, is a once-daily pill already approved for preventing strokes post-hip and knee replacements.
  • The drug's approval offers a new treatment option for afib patients, who have primarily relied on warfarin, a difficult-to-manage blood thinner.
  • Xarelto functions by blocking clotting protein factor Xa and carries a boxed warning about stroke risk if discontinued without physician advice.

Lifestyle and Metformin Interventions Show Significant Benefits in Diabetes Prevention

A comprehensive analysis of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) reveals that lifestyle changes and metformin significantly reduce the risk of developing diabetes. Adherent participants to these interventions experienced a lower incidence of diabetes and accrued more quality-adjusted life-years (QALYs) compared to those on placebo. The study also highlights the cost-effectiveness of these interventions from a health system perspective, with lifestyle and metformin interventions being cost-saving relative to placebo.

Four Key Drivers Reshaping Successful Oncology Drug Launches in Modern Market

  • The oncology market is experiencing significant transformation, with growth rates slowing despite remaining the top therapy area, requiring new strategic approaches for successful drug launches.
  • Companies must focus on optimal indication sequencing, patient segmentation through biomarkers, and novel payer acceptance strategies to navigate increasingly restrictive market access.
  • Building a strong oncology franchise through long-term commitment, engagement with key opinion leaders, and strategic clinical trial planning is crucial for commercial success.

FDA Approves Lialda for Maintenance of Remission in Ulcerative Colitis Patients

The U.S. Food and Drug Administration (FDA) has approved Shire plc's Lialda (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis, following a six-month study demonstrating its safety and effectiveness. This approval adds to Lialda's previous indication for inducing remission in patients with active, mild to moderate ulcerative colitis.

Metallic Copper as an Antimicrobial Surface: A Comprehensive Review

This article reviews the antimicrobial properties of metallic copper surfaces, highlighting their effectiveness in killing bacteria, yeasts, and viruses. It discusses the historical use of copper, its mechanism of action, and recent clinical trials demonstrating its potential in reducing hospital-acquired infections.

Global Pharmaceutical R&D Outsourcing Trends: Industry Shifts Toward Strategic Partnerships and Offshore Operations

  • Pharmaceutical companies are increasingly outsourcing R&D activities upstream in the value chain, including basic chemistry research and preclinical studies, driven by cost pressures and CRO capability expansion.
  • Clinical trials are becoming more globally distributed, with emerging markets in Asia and Eastern Europe gaining prominence alongside traditional US and European research centers.
  • IT-enabled R&D services face growing competition from global IT outsourcing and BPO providers, challenging traditional CROs in data management and programming services.
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