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FDA Grants Priority Review for Therapy for Life-threatening Hereditary Immune Disease
FDA Grants Priority Review for Therapy for Life-threatening Hereditary Immune Disease
FDA Grants Priority Review for Therapy for Life-threatening Hereditary Immune Disease
February 23, 2023
If approved, pozelimab would be the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The target action date for the FDA decision is Aug. 20, 2023.
FDA Sets Goal Date for Blurry Vision Therapy
FDA Sets Goal Date for Blurry Vision Therapy
FDA Sets Goal Date for Blurry Vision Therapy
February 23, 2023
CSF-1 is a low-dose pilocarpine to treat patients with age-related blurry vision. The FDA has assigned a PDUFA goal date of Oct. 22, 2023
FDA to Hold Advisory Committee Meeting on Onpattro for Heart Failure Indication
FDA to Hold Advisory Committee Meeting on Onpattro for Heart Failure Indication
FDA to Hold Advisory Committee Meeting on Onpattro for Heart Failure Indication
February 22, 2023
Alnylam is seeking approval for Onpattro’s use in cardiomyopathy related to transthyretin-mediated (ATTR) amyloidosis. The FDA set an action date of Oct. 8, 2023.
BMS Warns of Liver Damage from Sprycel
BMS Warns of Liver Damage from Sprycel
BMS Warns of Liver Damage from Sprycel
February 22, 2023
Patients who have had liver problems in the past may be at risk of liver damage from Sprycel, which is used to treat patients with chronic myeloid leukemia.
FDA Approves Extended Release Austedo
FDA Approves Extended Release Austedo
FDA Approves Extended Release Austedo
February 22, 2023
The new once-daily formulation of Austedo is used to treat adults with tardive dyskinesia and chorea associated with Huntington’s disease.
FDA Grants Priority Review for Pfizer’s RSV Vaccine
FDA Grants Priority Review for Pfizer’s RSV Vaccine
FDA Grants Priority Review for Pfizer’s RSV Vaccine
February 21, 2023
If approved, RSVpreF would be the first vaccine for administration to pregnant women to help protect against RSV disease in infants. The FDA has set an action date for August 2023.
FDA Grants Accelerated Approval to Filspari for Rare Kidney Disease
FDA Grants Accelerated Approval to Filspari for Rare Kidney Disease
FDA Grants Accelerated Approval to Filspari for Rare Kidney Disease
February 21, 2023
Filspari will be available for a wholesale acquisition cost of $9,900 for a 30-day supply, and administrated through a REMS program because of the risk of liver abnormalities.
FDA Approves First Drug for Geographic Atrophy Due to AMD
FDA Approves First Drug for Geographic Atrophy Due to AMD
FDA Approves First Drug for Geographic Atrophy Due to AMD
February 21, 2023
Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.
Moderna to Offer Free COVID-19 Vaccine for Uninsured
Moderna to Offer Free COVID-19 Vaccine for Uninsured
Moderna to Offer Free COVID-19 Vaccine for Uninsured
February 21, 2023
The U.S. public health emergency response to COVID-19 ends May 11, 2023, and the transition to more traditional healthcare coverage will begin later this year.
FDA Extends Review of Fezolinetant for Menopause Symptoms
FDA Extends Review of Fezolinetant for Menopause Symptoms
FDA Extends Review of Fezolinetant for Menopause Symptoms
February 20, 2023
The review has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is May 22, 2023.
ICER Gives NASH Drug Resmetirom High Marks, Obeticholic Acid Not So Much
ICER Gives NASH Drug Resmetirom High Marks, Obeticholic Acid Not So Much
ICER Gives NASH Drug Resmetirom High Marks, Obeticholic Acid Not So Much
February 20, 2023
At a placeholder price of $19,000, resmetirom would produce cost savings, says the drug evaluation group. Obeticholic acid’s price would need to be slashed to meet a commonly used cost-effectiveness threshold.
Approves Enzyme Replacement Therapy for Rare Disease
Approves Enzyme Replacement Therapy for Rare Disease
Approves Enzyme Replacement Therapy for Rare Disease
February 19, 2023
Lamzeda has been approved to treat patients with alpha-mannosidosis, a rare genetic condition. It will be available in the first half of this year.
Mark Cuban Assails PBMs at AAM meeting
Mark Cuban Assails PBMs at AAM meeting
Mark Cuban Assails PBMs at AAM meeting
February 18, 2023
Cuban, of "Shark Tank' fame and owner of the Dallas Mavericks, called drugs prices ‘insane’ and used some profanity when talking pharmacy benefit managers at the annual meeting of the Association for Accessible Medicines yesterday. Cuban has co-founded an online pharmacy that he says will make drug prices lower and transparent.
Navitus Adds Biosimilar Amjevita to Formulary
Navitus Adds Biosimilar Amjevita to Formulary
Navitus Adds Biosimilar Amjevita to Formulary
February 17, 2023
Navitus will be accessing the Humira biosimilar Amjevita through the lower wholesale acquisition cost option.
FDA Grants Priority Review to Prevymis to Prevent CMV After Kidney Transplants
FDA Grants Priority Review to Prevymis to Prevent CMV After Kidney Transplants
FDA Grants Priority Review to Prevymis to Prevent CMV After Kidney Transplants
February 17, 2023
The Prescription Drug User Fee Act action date is June 5, 2023. Prevymis is already approved to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant.
FDA Grants Priority Review to AMD Therapy
FDA Grants Priority Review to AMD Therapy
FDA Grants Priority Review to AMD Therapy
February 17, 2023
Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.
FDA Grants Priority Review Talzenna/Xtandi Combo in Prostate Cancer
FDA Grants Priority Review Talzenna/Xtandi Combo in Prostate Cancer
FDA Grants Priority Review Talzenna/Xtandi Combo in Prostate Cancer
February 16, 2023
Phase 3 data showed that the combination resulted in a 37% reduction in risk of disease progression or death in men with advanced prostate cancer.
PBMs in the Spotlight at Senate Hearing
PBMs in the Spotlight at Senate Hearing
PBMs in the Spotlight at Senate Hearing
February 16, 2023
Senators want more insight into PBM practices and the role they play in the healthcare ecosystem.
How Personalized Medicine Can Accelerate the Shift to Value-Based Care
How Personalized Medicine Can Accelerate the Shift to Value-Based Care
How Personalized Medicine Can Accelerate the Shift to Value-Based Care
February 16, 2023
Abarca's Nicole (Gupta) Bulochnik, Pharm.D., talks about how personalized medicine could be integrated into value-based care to accelerate uptake.
Value-based Outcomes Contracts Can Address High-Cost Gene Therapies
Value-based Outcomes Contracts Can Address High-Cost Gene Therapies
Value-based Outcomes Contracts Can Address High-Cost Gene Therapies
February 15, 2023
Javier Gonzalez, Pharm.D., at Abarca Health, talks about how value-based pricing arrangements can align incentives among stakeholders for specialty disease management.
CVS Caremark Removes 5 Brands from Drug List
CVS Caremark Removes 5 Brands from Drug List
CVS Caremark Removes 5 Brands from Drug List
February 15, 2023
The branded therapies were removed in favor of generics effective April 2023. CVS Caremark also added 13 generics to its Performance Drug List.
Sen. Cantwell to Hold Hearing on PBMs
Sen. Cantwell to Hold Hearing on PBMs
Sen. Cantwell to Hold Hearing on PBMs
February 14, 2023
The hearing will discuss the role of PBMs in healthcare and the Pharmacy Benefit Manager Transparency Act, legislation that has been submitted by Sens. Maria Cantwell and Chuck Grassley.
Ferring Launches First Microbiome Therapy to Prevent C. Diff Infection
Ferring Launches First Microbiome Therapy to Prevent C. Diff Infection
Ferring Launches First Microbiome Therapy to Prevent C. Diff Infection
February 14, 2023
No list price was provided for Rebyota but Ferring is offering copay and patient assistance programs.
FDA Refuses NDA for Cutaneous T-Cell Lymphoma
FDA Refuses NDA for Cutaneous T-Cell Lymphoma
FDA Refuses NDA for Cutaneous T-Cell Lymphoma
February 14, 2023
The FDA indicated that Soligenix’s application for HyBryte, a novel photodynamic therapy, was incomplete.
FDA Warns About Hospira’s Pediatric Indication on Potassium Phosphates
FDA Warns About Hospira’s Pediatric Indication on Potassium Phosphates
FDA Warns About Hospira’s Pediatric Indication on Potassium Phosphates
February 13, 2023
Hospira/Pfizer’s potassium phosphates product alone may produce daily aluminum exposures of up to twice of the FDA-recommended limit for children.
FDA Grants Priority Review for Linzess in Children, Adolescents
FDA Grants Priority Review for Linzess in Children, Adolescents
FDA Grants Priority Review for Linzess in Children, Adolescents
February 13, 2023
If approved, Linzess would be the first and only FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age. The PDUFA date is June 14th, 2023.
Blackley on the Impact of State PBM Regulations
Blackley on the Impact of State PBM Regulations
Blackley on the Impact of State PBM Regulations
February 13, 2023
Chris Blackley, co-founder and chief executive officer of Prescryptive Health, discusses the laws that states that are implementing to restrict PBM practices and the impact on patients and employers.
FDA Expands Cibinqo Label for Atopic Dermatitis in Adolescents
FDA Expands Cibinqo Label for Atopic Dermatitis in Adolescents
FDA Expands Cibinqo Label for Atopic Dermatitis in Adolescents
February 11, 2023
Cibinqo is an oral, once-daily JAK1 inhibitor now approved for those 12 years of age and older.
3 New, and High-Cost, Gene Therapies are Expected This Year
3 New, and High-Cost, Gene Therapies are Expected This Year
3 New, and High-Cost, Gene Therapies are Expected This Year
February 10, 2023
High-priced gene therapies challenge payers to provide access. They are watching the products to be approved the first half of this year.
FDA Grants Full Approval to Jemperli for Endometrial Cancer
FDA Grants Full Approval to Jemperli for Endometrial Cancer
FDA Grants Full Approval to Jemperli for Endometrial Cancer
February 10, 2023
Conversion from accelerated to regular approval was based on long-term outcomes from a phase 1 trial, which demonstrated an overall response rate of 45.4%.
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