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All News - Page 29

RxBenefits Provides New Solutions to Facilitate Access to Patient Assistance Programs
RxBenefits Provides New Solutions to Facilitate Access to Patient Assistance Programs
RxBenefits Provides New Solutions to Facilitate Access to Patient Assistance Programs
March 27, 2023
RxBenefits helps patients in self-funded plans find and apply for alternative sources of funding for specialty medicines and facilitates enrollment.
FDA Approves First Treatment for Rare Immunodeficiency Disease
FDA Approves First Treatment for Rare Immunodeficiency Disease
FDA Approves First Treatment for Rare Immunodeficiency Disease
March 27, 2023
Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
March 24, 2023
Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
FDA Rejects NDA for Extended-Release Jakafi
FDA Rejects NDA for Extended-Release Jakafi
FDA Rejects NDA for Extended-Release Jakafi
March 24, 2023
Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.
Impurities Lead to Recall of 10 Lots of Dabigatran
Impurities Lead to Recall of 10 Lots of Dabigatran
Impurities Lead to Recall of 10 Lots of Dabigatran
March 23, 2023
The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
Committee Sends PBM Transparency Bill to Full Senate
Committee Sends PBM Transparency Bill to Full Senate
Committee Sends PBM Transparency Bill to Full Senate
March 23, 2023
The proposed legislation, sponsored by Sens. Chuck Grassley and Maria Cantwell, aims to increase transparency of PBM business practices.
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
March 23, 2023
Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.
California Selects Generic Company Civica Rx as Insulin Partner
California Selects Generic Company Civica Rx as Insulin Partner
California Selects Generic Company Civica Rx as Insulin Partner
March 22, 2023
CalRx will work with Civica to provide the most commonly used short- and long-acting insulins at planned prices of no more than $30 a vial and $55 for a box of five pre-filled pens.
Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA
Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA
March 22, 2023
Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.
FDA Wants More Information about AbbVie’s Parkinson’s Therapy
FDA Wants More Information about AbbVie’s Parkinson’s Therapy
FDA Wants More Information about AbbVie’s Parkinson’s Therapy
March 22, 2023
In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
FDA Extends Evkeeza Indication to Include Young Children
FDA Extends Evkeeza Indication to Include Young Children
FDA Extends Evkeeza Indication to Include Young Children
March 22, 2023
Evkeeza treats a rare form of high cholesterol. It is now approved for patients as young of 5 years of age.
Sanofi Slashes Lantus List Price by 78%
Sanofi Slashes Lantus List Price by 78%
Sanofi Slashes Lantus List Price by 78%
March 18, 2023
The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance.
FDA Expands Illuccix Label to Identify Patients for Treatment with Pluvicto
FDA Expands Illuccix Label to Identify Patients for Treatment with Pluvicto
March 16, 2023
Illuccix is for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
Hemophilia Groups Protest BCBS of Tennessee Formulary Exclusions
Hemophilia Groups Protest BCBS of Tennessee Formulary Exclusions
Hemophilia Groups Protest BCBS of Tennessee Formulary Exclusions
March 16, 2023
The patient groups say the insurer is cutting off access to important medications. The Tennessee Blues plans say many of the drugs that it excluded from coverage have zero utilization.
HHS Names 27 Drugs Subject to Medicare Inflation Rebates
HHS Names 27 Drugs Subject to Medicare Inflation Rebates
HHS Names 27 Drugs Subject to Medicare Inflation Rebates
March 15, 2023
Medicare Part B beneficiaries are expected to save between $2 and $390 per average dose starting April 1, 2023.
Bacterial Contamination Leads to Recall of Antifungal Drug
Bacterial Contamination Leads to Recall of Antifungal Drug
Bacterial Contamination Leads to Recall of Antifungal Drug
March 14, 2023
Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.
Novo Nordisk Cuts Price on Several Insulin Products by 75%
Novo Nordisk Cuts Price on Several Insulin Products by 75%
Novo Nordisk Cuts Price on Several Insulin Products by 75%
March 14, 2023
The lower prices will take effect on Jan. 1, 2024, on both pre-filled pens and vials of basal, bolus and pre-mix insulins, including Levemir, Novolin, NovoLog and NovoLog Mix 70/30.
VA to Cover the Alzheimer’s Drug Leqembi
VA to Cover the Alzheimer’s Drug Leqembi
VA to Cover the Alzheimer’s Drug Leqembi
March 14, 2023
The VA’s guidelines would exclude anyone who has had a stroke or seizure within the last year, as well as those who have MRIs that show evidence of microhemmorrhages, aneurysms, lesions or tumors.
FDA Approves First Treatment for Rett syndrome
FDA Approves First Treatment for Rett syndrome
FDA Approves First Treatment for Rett syndrome
March 13, 2023
Daybue will be available by the end of April with a list price of about $375,000 annually.
CMS Grants Aponvie Pass Through Status
CMS Grants Aponvie Pass Through Status
CMS Grants Aponvie Pass Through Status
March 13, 2023
Aponvie is the first intravenous version of aprepitant adults to prevent postoperative nausea and vomiting.
CMS Grants Pass-through Reimbursement for Iheezo
CMS Grants Pass-through Reimbursement for Iheezo
CMS Grants Pass-through Reimbursement for Iheezo
March 13, 2023
Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.
FDA Approves Novel Nasal Spray for Migraine
FDA Approves Novel Nasal Spray for Migraine
FDA Approves Novel Nasal Spray for Migraine
March 10, 2023
Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved for patients with acute migraine.
VA Adds ALS Therapy Radicava ORS to National Formulary
VA Adds ALS Therapy Radicava ORS to National Formulary
VA Adds ALS Therapy Radicava ORS to National Formulary
March 10, 2023
Radicava ORS will be available with a national prior authorization process in place.
FDA Greenlights Generic Leukemia Treatment
FDA Greenlights Generic Leukemia Treatment
FDA Greenlights Generic Leukemia Treatment
March 10, 2023
Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.
Payers Want Value from Pharma Specialty Programs, Surveys Find
Payers Want Value from Pharma Specialty Programs, Surveys Find
Payers Want Value from Pharma Specialty Programs, Surveys Find
March 9, 2023
Payers are looking to pharmaceutical companies for innovative partnerships that provide patient access, positive clinical outcomes and reduced costs in specialty disease areas, AmerisourceBergen finds.
FDA Accepts sNDA for Jardiance in Children 10 to 17 with Diabetes
FDA Accepts sNDA for Jardiance in Children 10 to 17 with Diabetes
FDA Accepts sNDA for Jardiance in Children 10 to 17 with Diabetes
March 8, 2023
If approved, Jardiance would be the first SGLT2 inhibitor indicated for this population. A decision is expected in the second quarter of 2023.
FDA Assigns Target Date for Voxzogo in Young Children with Dwarfism
FDA Assigns Target Date for Voxzogo in Young Children with Dwarfism
FDA Assigns Target Date for Voxzogo in Young Children with Dwarfism
March 8, 2023
Voxzogo is already available to treat patients older than five years with a genetic cause of dwarfism. The FDA has set a PDUFA of Oct. 21, 2023, for children younger than 5.
NDA Sets Goal Date for Skin Infection Gel
NDA Sets Goal Date for Skin Infection Gel
NDA Sets Goal Date for Skin Infection Gel
March 7, 2023
If approved, berdazimer could be the first prescription product treat molluscum, a common skin infection caused by poxvirus. The Prescription Drug User Fee Act goal date is Jan. 5, 2024.
FDA Sets Action Date for Nerve Disorder Drug
FDA Sets Action Date for Nerve Disorder Drug
FDA Sets Action Date for Nerve Disorder Drug
March 7, 2023
With a Prescription Drug User Fee Act action date of Dec. 22, 2023, eplontersen is an antisense medicine to treat patients living with hereditary transthyretin-mediated amyloid polyneuropathy, which results in nerve damage.
FDA Extends Review of Hemophilia A Gene Therapy
FDA Extends Review of Hemophilia A Gene Therapy
FDA Extends Review of Hemophilia A Gene Therapy
March 7, 2023
The agency has set a new PDUFA target action date of June 30, 2023, for Roctavian. If approved, it would be the first one-time gene therapy for hemophilia. A.
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