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FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
Growth of Value-Based Purchasing For Cell & Gene Therapies
Rx Data Reporting Stops Short of Price Transparency PBMs find a way around CMS requirement meant to prevent hidden rebates
FDA Approves Mesoblast’s First-Of-Its-Kind Cell Therapy
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
PTC Wins FDA Approval For First Brain-Delivered Gene Therapy Kebilidi
Kebilidi represents the 13th gene therapy to score an FDA nod, but it's the first gene therapy to be administered directly in the brain.
FDA Approves Aucatzyl for Adults with Aggressive Leukemia
Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. The wholesale…
Sequoia, IOA Re and Rockport Benefits Form Carbon Stop Loss Solutions
New singular brand spotlights innovative employer stop loss and managed care offerings that are stronger by design CONSHOHOCKEN, PA, August 28, 2024 – Sequoia Reinsurance Services, IOA…
FDA Signs Off on Adaptimmune’s Tecelra
Patients with a certain type of synovial sarcoma have a new treatment option for the first time in more than a decade as the…
Overcoming Vulnerabilities For Stewards of Member Health Data
As cybercriminals target valuable health and personal data, cyberattacks are a growing threat for healthcare organizations and self-insured companies. In a feature article for The…
Sarepta Duchenne Gene Therapy Wins Broader Use From FDA
Despite mixed results in testing, agency officials determined Elevidys showed enough to warrant a label that includes all patients at least 4 years of…
The Dangers, Cost of Weight Loss Drugs — How to Avoid a Life Sentence
Beyond being a major public health challenge, obesity carries extreme implications for employers and their teams. In fact, a recent report estimates obesity cost…
Bristol Myers Secures Another FDA Go-Ahead For Breyanzi
In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell…
BMS CAR-T Therapy Wins FDA Approval for Expanded Use
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular…
Pfizer Will Charge $3.5M For Its First FDA-Approved Gene Therapy
Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag…
FDA Greenlights BMS, J&J CAR-T Therapies
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of…
Orchard Therapeutics Outlines U.S. Launch Plans For Lenmeldy
Orchard Therapeutics announced the U.S. Food and Drug Administration has approved Lenmeldy™, formerly known as OTL-200, for the treatment of children with pre-symptomatic late…
U.S. FDA Approves Bristol Myers Squibb’s Breyanzi
U.S. FDA Approves Bristol Myers Squibb’s Breyanzi ® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic…
U.S. FDA Grants Accelerated Approval For Iovance’s Skin Cancer Therapy
Feb 16 (Reuters) - Iovance Biotherapeutics (IOVA.O), opens new tab said on Friday the U.S. health regulator has granted an accelerated approval for its cell therapy…
Vertex, CRISPR’s Gene-Editing Therapy Casgevy Wins Early FDA Nod
he FDA has approved Vertex and CRISPR's gene-editing therapy Casgevy to treat beta thalassemia. Casgevy becomes the first therapy for the rare blood disorder…
Carbon Branch Advisory Statement — Claim Payment Integrity
False Claims Act Settlements and Judgments Exceed $2.68 Billion in Fiscal Year 2023 - Highest Number of Settlements and Judgements in History
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