Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
Walgreens is expanding its specialty pharmacy services and renaming AllianceRx Walgreens Pharmacy as Walgreens Specialty Pharmacy.
Beginning in June 2024, Quallent Pharmaceuticals will provide Evernorth a high- and low-concentration interchangeable biosimilar of Humira.
Ojemda will have a wholesale acquisition cost of $33,916 for a 28 day supply and will be distributed through specialty pharmacies Biologics by McKesson and Onco360.
New White Paper looks at the solutions and policy options of how to pay for high-cost gene therapies when there is still so much uncertainty about the outcomes and the durability of clinical benefits.
Dr. Reddy’s is recalling five lots of Javygtor and one lot of generic sapropterin dihydrochloride because discoloration could lead to decreased potency. Sapropterin is used to treat an inherited metabolic disorder.
Lutathera is a radiotherapeutic that is now approved for patients 12 years and older neuroendocrine tumors in the pancreas or gastrointestinal tract.
ImmunityBio’s Anktiva is an antibody cytokine fusion protein approved to treat patients with non-muscle invasive bladder cancer.
Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.
Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.
Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.
The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.
More than half of those survey by KFF who were disenrolled from Medicaid said they put off needed medical care because of costs.
Jeffrey Casberg, M.S., R.Ph., a senior vice president of clinical pharmacy at IPD Analytics LLC, a drug intelligence firm that advises payers and pharmaceutical companies, talks about how payers are thinking about weight-loss drugs.
Fasenra is now approved to treat patients aged 6 and older with eosinophilic asthma, a rare form of asthma.
The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
Ventegra, which provides drug benefit solutions, is also converting to a nonprofit status, which will be completed June 30, 2024.
The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.
FDA officials are looking for additional information about the infusion device used to deliver apomorphine.
Caps on Medicare Part D cost sharing as a result of the Inflation Reduction Act, could reduce members’ financial incentive for switching to a biosimilar, suggests the newest Samsung Bioepis Quarterly Biosimilar Market Report.
The quality-adjusted life-years tool has been misunderstood, Dr. Joshua Cohen says. QALYs are a measure of the value that comes from restoring a person to health, not about discrimination.
Approved in late September 2022, Relyvrio will no longer be available for new amyotrophic lateral sclerosis (ALS) patients.
The FDA is also considering a separate BLA for a 2 mL syringe. Bimzelx is already available to treat plaque psoriasis as a 1 ml syringe; a dose is two subcutaneous injections with a cost of $7,200 per syringe.
Zevtera was approved to treat Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia.
