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All News - Page 10

FDA Approves Bladder Cancer Immunotherapy
FDA Approves Bladder Cancer Immunotherapy
FDA Approves Bladder Cancer Immunotherapy
April 23, 2024
ImmunityBio’s Anktiva is an antibody cytokine fusion protein approved to treat patients with non-muscle invasive bladder cancer.
FDA Approves Pen Form of Entyvio for Crohn’s Disease
FDA Approves Pen Form of Entyvio for Crohn’s Disease
FDA Approves Pen Form of Entyvio for Crohn’s Disease
April 19, 2024
Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.
FDA Approves Stelara Biosimilar, Selarsdi
FDA Approves Stelara Biosimilar, Selarsdi
April 18, 2024
Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine
FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine
April 17, 2024
The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.
Payers Recognize the Benefits, but Still See Weight Loss Drugs through a Cost Lens
Payers Recognize the Benefits, but Still See Weight Loss Drugs through a Cost Lens
Payers Recognize the Benefits, but Still See Weight Loss Drugs through a Cost Lens
April 12, 2024
Jeffrey Casberg, M.S., R.Ph., a senior vice president of clinical pharmacy at IPD Analytics LLC, a drug intelligence firm that advises payers and pharmaceutical companies, talks about how payers are thinking about weight-loss drugs.
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Drugs to Watch: Mental Health Conditions
Drugs to Watch: Mental Health Conditions
April 11, 2024
The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
Ventegra Launches Point-of-Sale Rebate Program
Ventegra Launches Point-of-Sale Rebate Program
Ventegra Launches Point-of-Sale Rebate Program
April 10, 2024
Ventegra, which provides drug benefit solutions, is also converting to a nonprofit status, which will be completed June 30, 2024.
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Drugs to Watch: Lung Cancer
Drugs to Watch: Lung Cancer
April 10, 2024
The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.
Алексей Закиров
Humira Biosimilars Have a Slow Uptake, Finds Samsung Bioepis Report
Humira Biosimilars Have a Slow Uptake, Finds Samsung Bioepis Report
April 8, 2024
Caps on Medicare Part D cost sharing as a result of the Inflation Reduction Act, could reduce members’ financial incentive for switching to a biosimilar, suggests the newest Samsung Bioepis Quarterly Biosimilar Market Report.
Tuft’s Joshua Cohen Talks about Quality-Adjusted Life-Years
Tuft’s Joshua Cohen Talks about Quality-Adjusted Life-Years
Tuft’s Joshua Cohen Talks about Quality-Adjusted Life-Years
April 5, 2024
The quality-adjusted life-years tool has been misunderstood, Dr. Joshua Cohen says. QALYs are a measure of the value that comes from restoring a person to health, not about discrimination.
Amylyx Pulls ALS Treatment Off Market With a Few Thousand Still on Treatment as of Late '23
Amylyx Pulls ALS Treatment Off Market With a Few Thousand Still on Treatment as of Late '23
Amylyx Pulls ALS Treatment Off Market With a Few Thousand Still on Treatment as of Late '23
April 5, 2024
Approved in late September 2022, Relyvrio will no longer be available for new amyotrophic lateral sclerosis (ALS) patients.
FDA Accepts Supplemental BLA for Bimzelx in Hidradenitis Suppurativa
FDA Accepts Supplemental BLA for Bimzelx in Hidradenitis Suppurativa
FDA Accepts Supplemental BLA for Bimzelx in Hidradenitis Suppurativa
April 4, 2024
The FDA is also considering a separate BLA for a 2 mL syringe. Bimzelx is already available to treat plaque psoriasis as a 1 ml syringe; a dose is two subcutaneous injections with a cost of $7,200 per syringe.
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IRA is Expected to Cut Out-of-Pocket Costs by 28% for Women in Medicare
IRA is Expected to Cut Out-of-Pocket Costs by 28% for Women in Medicare
April 2, 2024
In 2025, the out-of-pocket cap and other Part D related provisions in the Inflation Reduction Act are projected to save women in Medicare an average of 28% in out-of-pocket costs, according to a new analysis from the Office of the Assistant Secretary for Planning and Evaluation.
ICER to Shine a Light on Clinical Trial Diversity
ICER to Shine a Light on Clinical Trial Diversity
ICER to Shine a Light on Clinical Trial Diversity
March 28, 2024
Foluso Agboola discusses the framework that the Institute for Clinical and Economic Review has developed for assessing whether clinical trial populations represent the real-world patient population.
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FDA Approves Vafseo for Anemia in Kidney Disease
FDA Approves Vafseo for Anemia in Kidney Disease
March 28, 2024
Vafseo, an oral therapy to treat patients with anemia due to chronic kidney, will be available in January 2025. About 40% of patients who could be treated with Vafseo have coverage through Medicare Advantage plans.
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