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FDA Approves First Treatment for Nasopharyngeal Carcinoma
FDA Approves First Treatment for Nasopharyngeal Carcinoma
FDA Approves First Treatment for Nasopharyngeal Carcinoma
October 30, 2023
Loqtorzi is indicated in combination with chemotherapy for first-line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy.
FDA Approves New Duchenne Muscular Dystrophy Drug
FDA Approves New Duchenne Muscular Dystrophy Drug
FDA Approves New Duchenne Muscular Dystrophy Drug
October 27, 2023
Agamree is a novel corticosteroid that will be available in the first quarter of 2024.
J&J Warns of Risk of Respiratory Depression with Spravato
J&J Warns of Risk of Respiratory Depression with Spravato
J&J Warns of Risk of Respiratory Depression with Spravato
October 27, 2023
Based on reports from post-marketing experience, Spravato’s warnings and precautions section now includes the risk of respiratory depression.
Lilly’s First-in-Class Therapy for Ulcerative Colitis Get FDA Approval
Lilly’s First-in-Class Therapy for Ulcerative Colitis Get FDA Approval
Lilly’s First-in-Class Therapy for Ulcerative Colitis Get FDA Approval
October 27, 2023
Mirikizumab — now with the brand name — Omvoh has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.
Study Reveals Inconsistent Wait Times for Decisions on Cancer Drug Coverage
Study Reveals Inconsistent Wait Times for Decisions on Cancer Drug Coverage
Study Reveals Inconsistent Wait Times for Decisions on Cancer Drug Coverage
October 27, 2023
The mean lag time between FDA approval and insurance coverage for 89 cancer drugs ranged from 2.3 months to 8.2 months. But cancer drugs approved more recently were more likely to have shorter coverage lags.
Recall Impacts Exela and Civica Brands
Recall Impacts Exela and Civica Brands
Recall Impacts Exela and Civica Brands
October 26, 2023
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
FDA Sets New Review Date for Bladder Cancer Immunotherapy
FDA Sets New Review Date for Bladder Cancer Immunotherapy
FDA Sets New Review Date for Bladder Cancer Immunotherapy
October 26, 2023
N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine is being reviewed by the FDA to treat non-muscle-invasive bladder cancer. The goal date is April 23, 2023.
Subcutaneous Leqembi Clears More Amyloid than IV Formulation
Subcutaneous Leqembi Clears More Amyloid than IV Formulation
Subcutaneous Leqembi Clears More Amyloid than IV Formulation
October 26, 2023
In new data, 60% of the patients with early stage Alzheimer’s disease and who have low levels of the protein tau achieved cognitive improvement when treated with Leqembi.
FDA Assigns Review Date for Resubmission of Kidney Disease Treatment
FDA Assigns Review Date for Resubmission of Kidney Disease Treatment
FDA Assigns Review Date for Resubmission of Kidney Disease Treatment
October 25, 2023
Akebia has resubmitted its NDA for vadadustat with postmarketing safety data from Japan, where it has been on the market for more than three years. The new review date is March 27, 2024.
FDA Approves Tibsovo for IDH1 Mutated Myelodysplastic Syndromes
FDA Approves Tibsovo for IDH1 Mutated Myelodysplastic Syndromes
FDA Approves Tibsovo for IDH1 Mutated Myelodysplastic Syndromes
October 24, 2023
Tibsovo is also approved to treat patients with IDH1-mutant acute myeloid leukemia and bile duct cancer.
FDA Approves Byooviz as Interchangeable Lucentis Biosimilar
FDA Approves Byooviz as Interchangeable Lucentis Biosimilar
FDA Approves Byooviz as Interchangeable Lucentis Biosimilar
October 24, 2023
Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.
Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder
Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder
Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder
October 23, 2023
The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
FDA Approves First Subcutaneous Infliximab for IBD
FDA Approves First Subcutaneous Infliximab for IBD
FDA Approves First Subcutaneous Infliximab for IBD
October 23, 2023
Zymfentra is a subcutaneous version of infliximab.
FDA Expands Indication of Voxzogo for Young Children with Dwarfism
FDA Expands Indication of Voxzogo for Young Children with Dwarfism
FDA Expands Indication of Voxzogo for Young Children with Dwarfism
October 23, 2023
Voxzogo is now approved for all ages in children with achondroplasia, the most common form of dwarfism.
Phase 3 Trial Shows Significant Weight Loss with Mounjaro
Phase 3 Trial Shows Significant Weight Loss with Mounjaro
Phase 3 Trial Shows Significant Weight Loss with Mounjaro
October 20, 2023
Patients taking Mounjaro after a lifestyle intervention saw a weight reduction of almost 20%.
KFF: Premiums for Employer-Sponsored Insurance Increased 7% in 2023
KFF: Premiums for Employer-Sponsored Insurance Increased 7% in 2023
KFF: Premiums for Employer-Sponsored Insurance Increased 7% in 2023
October 19, 2023
The increase is close to inflation and wage growth but much steeper than the atypically small increase in 2022.
Review: Patients Can Safely Switch to Biosimilars
Review: Patients Can Safely Switch to Biosimilars
Review: Patients Can Safely Switch to Biosimilars
October 17, 2023
Researchers in this review suggest clinical trials of biosimilars include switching studies to assess the pharmacokinetics of the biosimilar candidate.
Questions Remain about Nonprescription Opill
Questions Remain about Nonprescription Opill
Questions Remain about Nonprescription Opill
October 16, 2023
Whether Opill (norgestrel) truly broadens access to daily contraception will depend on Medicaid coverage, requirements under the ACA and pharmacist prescribing.
Pfizer’s Velsipity Approved for Ulcerative Colitis
Pfizer’s Velsipity Approved for Ulcerative Colitis
Pfizer’s Velsipity Approved for Ulcerative Colitis
October 13, 2023
Velsipity is the second oral S1P receptor modulator approved by the FDA to treat patients with moderate-to-severe ulcerative colitis. The wholesale acquisition cost is $6,164 for a 30-day supply.
Study Explores Connection Between Adherence and Viral Suppression in Patients with HIV
Study Explores Connection Between Adherence and Viral Suppression in Patients with HIV
Study Explores Connection Between Adherence and Viral Suppression in Patients with HIV
October 13, 2023
Researchers identified age and insurance type as significant factors in viral suppression in patient with HIV because of their impact on patient adherence.
FDA Issues Complete Response for Alvotech’s Biosimilar of Stelara
FDA Issues Complete Response for Alvotech’s Biosimilar of Stelara
FDA Issues Complete Response for Alvotech’s Biosimilar of Stelara
October 12, 2023
The regulatory agency found deficiencies in its inspection of Alvotech’s Reykjavik, Iceland, facility. The company plans to resubmit its application once these are addressed.
FDA Approves Braftovi/Mektovi for Non-Small Cell Lung Cancer
FDA Approves Braftovi/Mektovi for Non-Small Cell Lung Cancer
FDA Approves Braftovi/Mektovi for Non-Small Cell Lung Cancer
October 12, 2023
The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.
PBM Ventegra Adds Yuflyma Biosimilar as Preferred Product
PBM Ventegra Adds Yuflyma Biosimilar as Preferred Product
PBM Ventegra Adds Yuflyma Biosimilar as Preferred Product
October 11, 2023
Yuflyma is on Ventegra’s public and private formulary on parity with the reference product Humira.
Court Ruling Takes Aim at Copay Accumulators
Court Ruling Takes Aim at Copay Accumulators
Court Ruling Takes Aim at Copay Accumulators
October 10, 2023
Insurers and PBMs now have to follow a 2020 rule in which accumulator programs can only be applied to brand name drugs that have generic equivalents available.
Express Scripts Lists Inpefa as Preferred on Medicare Formularies
Express Scripts Lists Inpefa as Preferred on Medicare Formularies
Express Scripts Lists Inpefa as Preferred on Medicare Formularies
October 10, 2023
Inpefa is an inhibitor of both SGLT2 and SGLT1, approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The wholesale acquisition cost is $598 per month.
Cosentyx Approved as an IV Formulation
Cosentyx Approved as an IV Formulation
Cosentyx Approved as an IV Formulation
October 9, 2023
The IV formulation has a wholesale acquisition cost of $2,115 per vial and will be available in the fourth quarter.
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
October 9, 2023
Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
Zoryve is Now Approved for Children with Plaque Psoriasis
Zoryve is Now Approved for Children with Plaque Psoriasis
Zoryve is Now Approved for Children with Plaque Psoriasis
October 6, 2023
The dosage of Zoryve for children 6 to 11 is the same as for those over the age of 12. The list price is same for both pediatrics and adults — $825 per tube.
Analysis: Medication Adherence Positively Impacts RA Patients’ Healthcare Costs and Usage
Analysis: Medication Adherence Positively Impacts RA Patients’ Healthcare Costs and Usage
Analysis: Medication Adherence Positively Impacts RA Patients’ Healthcare Costs and Usage
October 6, 2023
Patients who continued with their rheumatoid arthritis biologic medication tended to spend less on healthcare, had a lower chance of being hospitalized, and had shorter hospital stays.
What We’re Reading: the Nobel Prize in Medicine, Striking Healthcare Workers
What We’re Reading: the Nobel Prize in Medicine, Striking Healthcare Workers
What We’re Reading: the Nobel Prize in Medicine, Striking Healthcare Workers
October 5, 2023
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