FDA Grants Full Approval to Rybrevant in Lung Cancer
Rybrevant is indicated to be used in combination with chemotherapy as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.
HHS Issues Guidance for Medicare Prescription Drug Payment Plan
Beginning in 2025, people with Medicare Part D drug coverage will have the option to pay out-of-pocket costs in monthly payments spread out over the year.
Mercer Launches Technology Solution for Specialty Drugs
Mercer has teamed up with Free Market Health to offer employers Mercer SelectRx, which searches a network of specialty pharmacies for the lowest price on specialty medications.
FDA Sets Date for Full Approval of Ocaliva in Liver Disease
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.
Glaukos Launches Implantable Glaucoma Treatment
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.
FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease
The Prescription Drug User Fee Act action date is Aug. 28, 2024.
FDA Sets Review Date for Tislelizumab in Stomach Cancer
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
The FDA is reviewing Epkinly to treat relapsed or refractory follicular lymphoma. The target date is in August 2023.
KFF: Healthcare Affordability is an Election Issue
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
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.
FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma
Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.
FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma
Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024
FDA Sets Date for First-in-Class Lung Cancer Therapy
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
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.
IQVIA: Rebates put Biosimilar Manufacturers at a Disadvantage
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
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
Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
FDA Extends Review of Gene Therapy for Rare Immune Disorder
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.
FDA Approves Eohilia as an Oral Treatment for Eosinophilic Esophagitis
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.
FDA Grants Priority Review to Seladelpar as Second-line Treatment for Rare Liver Disease
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.
FDA Grants Priority Review to Engineered Tissue for Vascular Replacement
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.
Amneal Resubmits Application for Novel Parkinson’s Therapy
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.
The IRA’s Out-of-Pocket Cap to Benefit more than 1 Million People
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.
FDA Assigns Action Date for Arexvy to Prevent RSV in 50 to 59 Population
The Prescription Drug User Fee Act date is June 7, 2024, for the additional indication of preventing respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at increased risk. It is already approved for those over the age of 60.
FDA Sets PDUFA Date for Acoramidis in Heart Failure Indication
The FDA has set an action date of Nov. 29, 2024, to review acoramidis to treat patients with transthyretin amyloid cardiomyopathy.
FDA Sets Advisory Meeting for Abecma in Supplemental Multiple Myeloma Indication
The Oncologic Drugs Advisory Committee will meet on March 15, 2024, to review overall survival data for Abecma in earlier lines of treatment in relapsed or refractory multiple myeloma.
Rite Aid Completes Sale of Elixir Solutions
The sale, valued at about $576.5 million, is part of Rite Aid’s restructuring plan after filing for bankruptcy in October 2023.
FDA Issues CRL for Motion Sickness Drug
Defender Pharmaceuticals is working with U.S. Naval Medical Research Unit and NASA to develop intranasal scopolamine for use in military personnel and astronauts.
FDA Sets Review Dates for New Indications for Breyanzi
Bristol Myers Squibb is seeking approval of Breyanzi, a CD19-directed CAR T-cell therapy, to treat patients with follicular lymphoma and mantle cell lymphoma.
FDA Approves New Indication for Gammagard Liquid
Gammagard is an intravenous immunoglobulin therapy now approved to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.
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