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All News - Page 24

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.
Patients Oppose Prior Authorization Policies, Finds New Poll
Patients Oppose Prior Authorization Policies, Finds New Poll
Patients Oppose Prior Authorization Policies, Finds New Poll
March 6, 2023
The majority of consumers surveyed by Let My Doctor Decide support reforms to improve access and affordability.
FDA Grants Priority Review to Leqembi for Traditional Approval
FDA Grants Priority Review to Leqembi for Traditional Approval
FDA Grants Priority Review to Leqembi for Traditional Approval
March 6, 2023
The FDA plans to hold an advisory committee meeting to discuss the Alzheimer’s therapy. The agency has assigned Prescription Drug User Fee Act target action of July 6, 2023.
CDC Warns About Drug-Resistant Stomach Infections
CDC Warns About Drug-Resistant Stomach Infections
CDC Warns About Drug-Resistant Stomach Infections
March 3, 2023
Shigella cause an estimated 450,000 infections in the United States each year and an estimated $93 million in direct medical costs.
Cracked Lids Leads to Recall of Six Lots of Brimonidine Tartrate Solution
Cracked Lids Leads to Recall of Six Lots of Brimonidine Tartrate Solution
Cracked Lids Leads to Recall of Six Lots of Brimonidine Tartrate Solution
March 3, 2023
Brimonidine tartrate ophthalmic solution is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Janssen Submits NDA for Combo Tablet for Metastatic Prostate Cancer
Janssen Submits NDA for Combo Tablet for Metastatic Prostate Cancer
Janssen Submits NDA for Combo Tablet for Metastatic Prostate Cancer
March 2, 2023
Niraparib and abiraterone acetate plus prednisone has potential to address unmet need for patients with BRCA-positive metastatic castration-resistant prostate cancer.
FDA Accepts for Priority Review Drug for Rare Retinal Cancer
FDA Accepts for Priority Review Drug for Rare Retinal Cancer
FDA Accepts for Priority Review Drug for Rare Retinal Cancer
March 2, 2023
If approved, ADX-2191 could be the first marketed drug specifically for patients with primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023.
Updated ICER Analysis Shows Leqembi Still Not Cost-Effective
Updated ICER Analysis Shows Leqembi Still Not Cost-Effective
Updated ICER Analysis Shows Leqembi Still Not Cost-Effective
March 2, 2023
Leqembi would need a 66% to 19% discount from its wholesale acquisition cost of $26,500 a year to fall within commonly used cost-effectiveness thresholds.
Updated: Lilly Cuts Prices of Some Insulins and Caps Out-of-Pocket Costs
Updated: Lilly Cuts Prices of Some Insulins and Caps Out-of-Pocket Costs
Updated: Lilly Cuts Prices of Some Insulins and Caps Out-of-Pocket Costs
March 2, 2023
The price cuts apply to Lilly’s nonbranded insulin, Humalog, Humulin and its Lantus biosimilar.
FDA Approves Kevzara for Inflammatory Rheumatic Disease
FDA Approves Kevzara for Inflammatory Rheumatic Disease
FDA Approves Kevzara for Inflammatory Rheumatic Disease
March 1, 2023
Kevzara is the first biologic to treat patients with polymyalgia rheumatica (PMR). It is also approved to treat rheumatoid arthritis.
FDA Advisory Committee Supports Pfizer’s RSV Vaccine
FDA Advisory Committee Supports Pfizer’s RSV Vaccine
FDA Advisory Committee Supports Pfizer’s RSV Vaccine
March 1, 2023
If authorized, Pfizer’s RSV vaccine would be used to prevent respiratory disease caused by RSV in adults 60 years of age and older. An FDA decision is expected by May 2023.
Pfizer, BioNTech Seek Approval for Bivalent COVID-19 Vaccine as Primary Series
Pfizer, BioNTech Seek Approval for Bivalent COVID-19 Vaccine as Primary Series
Pfizer, BioNTech Seek Approval for Bivalent COVID-19 Vaccine as Primary Series
March 1, 2023
The companies have also submitted an EUA for a fourth dose of the bivalent COVID-19 vaccine in children 6 months through 4 years of age.
FDA Approves First Therapy for Rare Neuromuscular Disease
FDA Approves First Therapy for Rare Neuromuscular Disease
FDA Approves First Therapy for Rare Neuromuscular Disease
February 28, 2023
Skyclarys will be available in the second quarter of 2023 to treat patients with Friedreich’s ataxia, an ultra-rare, inherited neurodegenerative disorder. The wholesale acquisition cost is $370,000.
FDA Sets Action Date for Opdivo for Melanoma Indication
FDA Sets Action Date for Opdivo for Melanoma Indication
FDA Sets Action Date for Opdivo for Melanoma Indication
February 28, 2023
BMS is seeking an indication for Opdivo as monotherapy to treat patients with stage IIB or IIC melanoma after surgery. The FDA has assigned a Prescription Drug User Fee Act date of Oct. 13, 2023.
Study: Health Plans Align with ICER’s Drug Cost-Effectiveness Ratios
Study: Health Plans Align with ICER’s Drug Cost-Effectiveness Ratios
Study: Health Plans Align with ICER’s Drug Cost-Effectiveness Ratios
February 27, 2023
Investigators found an association between ICER’s value assessments and how U.S. commercial health plans cover specialty drugs.
PCMA Defends PBMs with Seven-Figure Ad Campaign
PCMA Defends PBMs with Seven-Figure Ad Campaign
PCMA Defends PBMs with Seven-Figure Ad Campaign
February 27, 2023
The ads focus on how PBMs promote competition in the prescription drug marketplace and provide choice for employers.
FDA Approves Weekly Hemophilia A Therapy
FDA Approves Weekly Hemophilia A Therapy
FDA Approves Weekly Hemophilia A Therapy
February 24, 2023
Altuviiio is a first-in-class therapy providing factor VIII replacement to prevent bleeding in patients with hemophilia A. It is expected to be available in April 2023.
Formulary Placement and Outcomes to Drive Physician Use of Humira Biosimilars
Formulary Placement and Outcomes to Drive Physician Use of Humira Biosimilars
Formulary Placement and Outcomes to Drive Physician Use of Humira Biosimilars
February 24, 2023
Bruce Feinberg, D.O., of Cardinal Health, said significantly changes are on the horizon for biosimilars, but physician comfort with and use of biosimilars will depend on things beyond their control, including formulary placement and utilization management efforts.
CMS Maintains Limited Coverage for Alzheimer’s Drugs
CMS Maintains Limited Coverage for Alzheimer’s Drugs
CMS Maintains Limited Coverage for Alzheimer’s Drugs
February 23, 2023
CMS said it will cover monoclonal antibodies to treat Alzheimer’s disease if they are approved through the standard review process and not through an accelerated approval.
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