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FDA Approves First Cellular Therapy for Type 1 Diabetes
FDA Approves First Cellular Therapy for Type 1 Diabetes
FDA Approves First Cellular Therapy for Type 1 Diabetes
June 29, 2023
In two small studies, patients were able to be free from insulin injections for a year or more.
Sarah Emond to Take Helm of ICER
Sarah Emond to Take Helm of ICER
Sarah Emond to Take Helm of ICER
June 28, 2023
Sarah Emond will continue with ICER’s efforts to assess drug cost-effectiveness and health plan access policies that began with founder Steve Pearson, M.D., who will transition to an advisor role in 2024.
Employer Group Issues Guide for Contracting with PBMs
Employer Group Issues Guide for Contracting with PBMs
Employer Group Issues Guide for Contracting with PBMs
June 28, 2023
The National Alliance of Healthcare Purchaser Coalitions has issued a playbook to help companies navigate what they see as a flawed PBM contracting model and lack of competition.
FDA Rejects Higher Dose of Eylea
FDA Rejects Higher Dose of Eylea
FDA Rejects Higher Dose of Eylea
June 28, 2023
At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.
FDA Approves Rystiggo for Generalized Myasthenia Gravis
FDA Approves Rystiggo for Generalized Myasthenia Gravis
FDA Approves Rystiggo for Generalized Myasthenia Gravis
June 27, 2023
It will be commercially available in the third quarter of 2023 and have a list price of $6,050 per vial.
FDA Sets Action Date for Hemophilia B Gene Therapy
FDA Sets Action Date for Hemophilia B Gene Therapy
FDA Sets Action Date for Hemophilia B Gene Therapy
June 27, 2023
Pfizer’s biologics license application (BLA) for the gene therapy fidanacogene elaparvovec has been assigned a PDUFA date in the second quarter of 2024.
FDA Converts Blincyto to Full Approval for Minimal Residual Disease in B-Cell ALL
FDA Converts Blincyto to Full Approval for Minimal Residual Disease in B-Cell ALL
FDA Converts Blincyto to Full Approval for Minimal Residual Disease in B-Cell ALL
June 26, 2023
Blincyto is immuno-oncology therapy that targets CD19 surface antigens on B cells to treat patients with acute lymphoblastic leukemia. Its current wholesale acquisition cost price is $4,900.15 per vial.
FDA Approves Pfizer’s Alopecia Drug
FDA Approves Pfizer’s Alopecia Drug
FDA Approves Pfizer’s Alopecia Drug
June 26, 2023
Now with the name Litfulo, ritlecitinib is the first oral treatment for adolescents with alopecia. It has an annual list price of $49,000.
First Gene Therapy for Duchenne Priced at $3.2 Million
First Gene Therapy for Duchenne Priced at $3.2 Million
First Gene Therapy for Duchenne Priced at $3.2 Million
June 23, 2023
Elevidys is a one-time therapy that delivers to muscle a gene that codes for a shortened, functional form of dystrophin, which is mutated in Duchenne muscular dystrophy.
Optum Rx’s Choice: Hyrimoz, Cyltezo and Amjevita
Optum Rx’s Choice: Hyrimoz, Cyltezo and Amjevita
Optum Rx’s Choice: Hyrimoz, Cyltezo and Amjevita
June 23, 2023
Optum Rx will include the three biosimilars on its standard formulary at parity with Humira.
FDA Rejects NDA for Fatty Liver Disease Therapy
FDA Rejects NDA for Fatty Liver Disease Therapy
FDA Rejects NDA for Fatty Liver Disease Therapy
June 23, 2023
The company plans to discontinue further research of obeticholic acid to treat nonalcoholic steatohepatitis (NASH) after the FDA asked for long-term outcomes data.
FDA Issues CRL for Treatment for Rare Retinal Cancer
FDA Issues CRL for Treatment for Rare Retinal Cancer
FDA Issues CRL for Treatment for Rare Retinal Cancer
June 22, 2023
Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.
FDA Approves Subcutaneous Vyvgart for Myasthenia Gravis
FDA Approves Subcutaneous Vyvgart for Myasthenia Gravis
FDA Approves Subcutaneous Vyvgart for Myasthenia Gravis
June 22, 2023
Vyvgart Hytrulo’s under-the-skin administration means it can be given in 30 to 90 seconds, compared with one hour for the intravenous product. It will be priced at parity to Vyvgart, which has a net price of $225,000 annually.
FDA Clears Jardiance and Synjardy for Kids with Type 2 Diabetes
FDA Clears Jardiance and Synjardy for Kids with Type 2 Diabetes
FDA Clears Jardiance and Synjardy for Kids with Type 2 Diabetes
June 22, 2023
Jardiance and Synjardy are the first SGLT2 inhibitors approved for children with type 2 diabetes.
Alex Jung: It’s time to Think Differently about Specialty Drugs
Alex Jung: It’s time to Think Differently about Specialty Drugs
Alex Jung: It’s time to Think Differently about Specialty Drugs
June 21, 2023
Employers and plans need to prioritize clinical efficacy over drug price, look for price reductions — and not rebates — on biosimilars, and advocate for a public option to cover gene therapies. These are just a few of ideas that consultant Alex Jung put forward at a meeting of the Midwest Business Group on Health.
Geron Submits NDA for First-in-Class Therapy for MDS
Geron Submits NDA for First-in-Class Therapy for MDS
Geron Submits NDA for First-in-Class Therapy for MDS
June 21, 2023
Imetelstat targets telomerase to inhibit uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies.
FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease
FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease
FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease
June 20, 2023
Lodoco targets the inflammation that is an underlying cause of atherosclerotic cardiovascular disease. It will be available in the second half of 2023.
FDA Issues Complete Response for Drug for Rare Fungal Infections
FDA Issues Complete Response for Drug for Rare Fungal Infections
FDA Issues Complete Response for Drug for Rare Fungal Infections
June 20, 2023
The FDA is requesting additional data and analysis for olorofim. F2G plans to resubmit revised NDA with complete data set from phase 2 study.
KFF Survey: Patients Concerned about Drug, Healthcare Costs
KFF Survey: Patients Concerned about Drug, Healthcare Costs
KFF Survey: Patients Concerned about Drug, Healthcare Costs
June 19, 2023
About a quarter of those surveyed said their insurance didn’t cover a needed prescription drug or charged a very high copay.
FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma
FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma
FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma
June 16, 2023
Columvi will cost about $350,000 for a fixed duration therapy with 12 treatments over eight and a half months.
Pfizer Cautions About Shortages of Certain Bicillin Formulations
Pfizer Cautions About Shortages of Certain Bicillin Formulations
Pfizer Cautions About Shortages of Certain Bicillin Formulations
June 16, 2023
The supply interruption is the result of a combination of factors, including significant increases in demand, an increase in syphilis infection rates, as well as competitive shortages.
New Senate Bill Focuses on PBM Compensation in Medicare Plans
New Senate Bill Focuses on PBM Compensation in Medicare Plans
New Senate Bill Focuses on PBM Compensation in Medicare Plans
June 15, 2023
If passed, PBMs would not be able to charge fees that are connected to the price of a drug, discounts, or rebates.
Labeling Mix up Leads to Recall of Dronabinol and Ziprasidone
Labeling Mix up Leads to Recall of Dronabinol and Ziprasidone
Labeling Mix up Leads to Recall of Dronabinol and Ziprasidone
June 15, 2023
Ziprasidone is used to treat patients with schizophrenia and bipolar disorder. Taking dronabinol instead may lead to worsening of mental illness symptoms.
Semaglutide for Weight Loss: To Cover or Not Cover?
Semaglutide for Weight Loss: To Cover or Not Cover?
Semaglutide for Weight Loss: To Cover or Not Cover?
June 14, 2023
Ozempic, Wegovy and other GLP-1 drugs present a challenge to payers in terms of costs and outcomes, finds PSG’s new Drug Benefit Design Report.
SmithRx is first PBM to Offer Humira Biosimilar Yusimry
SmithRx is first PBM to Offer Humira Biosimilar Yusimry
SmithRx is first PBM to Offer Humira Biosimilar Yusimry
June 13, 2023
SmithRx will offer Yusimry through Mark Cuban’s online pharmacy for $569.27, and members will be able to apply their insurance benefits.
FDA Approves Linzess to Treat Children with Constipation
FDA Approves Linzess to Treat Children with Constipation
FDA Approves Linzess to Treat Children with Constipation
June 13, 2023
Linzess is first FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age.
FDA Committee Recommends Sanofi/AstraZeneca’s RSV Vaccine for Infants
FDA Committee Recommends Sanofi/AstraZeneca’s RSV Vaccine for Infants
FDA Committee Recommends Sanofi/AstraZeneca’s RSV Vaccine for Infants
June 12, 2023
If approved, nirsevimab would be the first immunization specifically to protect infants through their first RSV season. The Prescription Drug User Fee Act date is in the third quarter of 2023.
Quality Issues Lead to Shortages of Common Cancer Drugs
Quality Issues Lead to Shortages of Common Cancer Drugs
Quality Issues Lead to Shortages of Common Cancer Drugs
June 12, 2023
More than 90% of cancer centers have experienced shortages of critical drugs. Erin R. Fox, Pharm.D., University of Utah Health, talks about why these shortages are happening and efforts that are being made to address them.
FDA Sets PDUFA Dates for First CRISPR Gene Edited Therapy
FDA Sets PDUFA Dates for First CRISPR Gene Edited Therapy
FDA Sets PDUFA Dates for First CRISPR Gene Edited Therapy
June 9, 2023
Exagamglogene autotemcel is being evaluated for patients with sickle cell disease and beta thalassemia, in which a patient’s own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin in red blood cells.
FDA Approves Novel Cyclosporine for Dry Eye Disease
FDA Approves Novel Cyclosporine for Dry Eye Disease
FDA Approves Novel Cyclosporine for Dry Eye Disease
June 8, 2023
Vevye (previously CyclASol) is a water-free, preservative-free solution, which allows for improved bioavailability and better efficacy on the target tissue.
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