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FDA Sets Date for Full Approval of Ocaliva in Liver Disease
FDA Sets Date for Full Approval of Ocaliva in Liver Disease
FDA Sets Date for Full Approval of Ocaliva in Liver Disease
February 29, 2024
The target action date is Oct. 15, 2024, for full approval of Ocaliva to treat patients with primary biliary cholangitis. The FDA is planning to hold an advisory committee meeting to discuss the application.
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Glaukos Launches Implantable Glaucoma Treatment
Glaukos Launches Implantable Glaucoma Treatment
February 29, 2024
iDose TR was approved to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It has a wholesale acquisition cost of $13,950 per dose/implant.
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FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease
FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease
February 28, 2024
The Prescription Drug User Fee Act action date is Aug. 28, 2024.
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FDA Sets Review Date for Tislelizumab in Stomach Cancer
FDA Sets Review Date for Tislelizumab in Stomach Cancer
February 28, 2024
The FDA has set an action in December 2024 for tislelizumab — now with the brand name Tevimbra — for metastatic gastric or gastroesophageal junction cancers.
FDA Grants Priority Review for Second Epkinly Indication
FDA Grants Priority Review for Second Epkinly Indication
FDA Grants Priority Review for Second Epkinly Indication
February 27, 2024
The FDA is reviewing Epkinly to treat relapsed or refractory follicular lymphoma. The target date is in August 2023.
FDA Expands Indication for Biktarvy for Those with Resistant HIV
FDA Expands Indication for Biktarvy for Those with Resistant HIV
FDA Expands Indication for Biktarvy for Those with Resistant HIV
February 27, 2024
Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.
CarelonRx to Launch Digital Weight Management Program
CarelonRx to Launch Digital Weight Management Program
CarelonRx to Launch Digital Weight Management Program
February 26, 2024
CarelonRx will provide digital coaching and wellness tools and incorporate behavioral and social health screenings for members.
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FDA Approves Simlandi, Third Interchangeable Humira Biosimilar
FDA Approves Simlandi, Third Interchangeable Humira Biosimilar
February 26, 2024
At the moment, Simlandi (adalimumab-ryvk) has the high-concentration, citrate-free, interchangeable Humira (adalimumab) market to itself.
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
February 23, 2024
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
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KFF: Healthcare Affordability is an Election Issue
KFF: Healthcare Affordability is an Election Issue
February 23, 2024
The economy and healthcare costs are the issues voters want to hear about going into the 2024 presidential election, finds a survey by KFF.
FDA Grants Priority Review to Dupixent in COPD
FDA Grants Priority Review to Dupixent in COPD
FDA Grants Priority Review to Dupixent in COPD
February 23, 2024
If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 2024.
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
February 22, 2024
Avalere’s Kolton Gustafson talks about CMS’ new model for negotiating outcomes-based agreements for sickle cell gene therapies for patients in state Medicaid programs.
FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma
FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma
FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma
February 21, 2024
Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.
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FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma
FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma
February 21, 2024
Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024
The VA Replaces Humira with Hadlima on National Formulary
The VA Replaces Humira with Hadlima on National Formulary
The VA Replaces Humira with Hadlima on National Formulary
February 20, 2024
Payers now covering Hadlima include United Healthcare, Prime Therapeutics and associated Blues plans, and some managed Medicare organizations.
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FDA Sets Date for First-in-Class Lung Cancer Therapy
FDA Sets Date for First-in-Class Lung Cancer Therapy
February 19, 2024
If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.
FDA Approves Amtagvi, the First TIL Therapy for a Solid Tumor
FDA Approves Amtagvi, the First TIL Therapy for a Solid Tumor
FDA Approves Amtagvi, the First TIL Therapy for a Solid Tumor
February 19, 2024
Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.
FDA Sets Date for Full Approval, Broader Indication for Elevidys
FDA Sets Date for Full Approval, Broader Indication for Elevidys
FDA Sets Date for Full Approval, Broader Indication for Elevidys
February 16, 2024
The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.
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IQVIA: Rebates put Biosimilar Manufacturers at a Disadvantage
IQVIA: Rebates put Biosimilar Manufacturers at a Disadvantage
February 15, 2024
Rebates, falling prices, and rebate walls, where drug manufacturers agree to a certain price in exchange for an exclusive contract with payers, limit competition and create a dynamic of misaligned incentives.
FDA Sets Goal Date for Augtyro for Solid Tumors with NTRK Gene Fusions
FDA Sets Goal Date for Augtyro for Solid Tumors with NTRK Gene Fusions
FDA Sets Goal Date for Augtyro for Solid Tumors with NTRK Gene Fusions
February 15, 2024
Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.
FDA Approves Onivyde for First-line Metastatic Pancreatic Cancer
FDA Approves Onivyde for First-line Metastatic Pancreatic Cancer
FDA Approves Onivyde for First-line Metastatic Pancreatic Cancer
February 14, 2024
Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
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FDA Extends Review of Gene Therapy for Rare Immune Disorder
FDA Extends Review of Gene Therapy for Rare Immune Disorder
February 14, 2024
Rocket’s application for Kresladi is being extended by three months for regulators to review additional information submitted at the request of the FDA. The new Prescription Drug User Fee Act (PDUFA) date is now June 30, 2024.
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Newly Approved Vaccines Face a Fragmented Policy Landscape
Newly Approved Vaccines Face a Fragmented Policy Landscape
February 13, 2024
The Inflation Reduction Act has helped to close some of the gaps in insurance coverage for vaccines, including some of the newly approved ones.
Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux
Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux
Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux
February 13, 2024
Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It has a list price of $650 for a 30-count bottle.
FDA Approves Eohilia as an Oral Treatment for Eosinophilic Esophagitis
FDA Approves Eohilia as an Oral Treatment for Eosinophilic Esophagitis
FDA Approves Eohilia as an Oral Treatment for Eosinophilic Esophagitis
February 12, 2024
Eohilia is a liquid formulation of budesonide that will be available by the end of February. It will have a wholesale acquisition cost of $1,875 per month.
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FDA Grants Priority Review to Seladelpar as Second-line Treatment for Rare Liver Disease
FDA Grants Priority Review to Seladelpar as Second-line Treatment for Rare Liver Disease
February 12, 2024
The FDA has set a Prescription Drug User Fee Act target action date of Aug. 14, 2024, for seladelpar to treat adults with primary biliary cholangitis.
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FDA Grants Priority Review to Engineered Tissue for Vascular Replacement
FDA Grants Priority Review to Engineered Tissue for Vascular Replacement
February 9, 2024
The FDA has set a Prescription Drug User Fee Act date of Aug. 10, 2024, for Human Acellular Vessel to repair arteries in patients with extremity vascular trauma.
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Amneal Resubmits Application for Novel Parkinson’s Therapy
Amneal Resubmits Application for Novel Parkinson’s Therapy
February 9, 2024
The FDA had issued a complete response letter (CRL) in July 2023 for IPX203 and asked for additional pharmacokinetic data of carbidopa, one of the drugs the oral, extended release therapy.
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The IRA’s Out-of-Pocket Cap to Benefit more than 1 Million People
The IRA’s Out-of-Pocket Cap to Benefit more than 1 Million People
February 9, 2024
In three states — California, Florida, and Texas — more than 100,000 Part D enrollees exceeded $2,000 in spending on prescription drugs in 2021, finds a new analysis from KFF.
CVS’s Health Services Revenue Grew to $186.8 Billion
CVS’s Health Services Revenue Grew to $186.8 Billion
CVS’s Health Services Revenue Grew to $186.8 Billion
February 8, 2024
CVS’s Health Services segment — which includes its PBM CVS Caremark — now accounts for more than half of CVS’s total revenue.
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