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Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.
Optum Rx’s Humira biosimilar strategy for 2023 was set up to allow for the most value in the first year, said CEO Heather Cianfrocco.
This update removes a previous limitation that it could not be used as the first therapy.
Newer treatments, including targeted and immunotherapies, have contributed to an increase in five-year survival rates for patients with some cancers.
CMS officials plan to engage with the public for feedback and insights as they implement the Medicare Drug Price Negotiation Program.
With this partnership, employers and their members using RxPreferred for their pharmacy benefit will have access to all medications available through Cost Plus Drugs.
Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.
Soleo Health will distribute Leqembi, the newly approved Alzheimer's therapy, to provider offices and infusion centers, as well as administer it across its own ambulatory infusions centers.
New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.
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Clarivate analysts have identified the treatments they forecast could deliver annual sales of more than $1 billion within five years. These include therapies for rare diseases, as well as HIV, Parkinson’s disease, Crohn’s disease, alopecia, and cancer.
Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.
The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee
The supplemental BLA is based on data from a confirmatory phase 3 trial. The submission was made the same day Eisai/Biogen received accelerated approval.
Lecanemab, now with the brand name Leqembi, will launch with a wholesale acquisition cost of $26,500 a year.
Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.
Rozanolixizumab is a monoclonal antibody that addresses a different driver of generalized myasthenia gravis. An FDA decision is expected in the second quarter of 2023.
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
Synergie Medication Collective, which launches this month, is focused on improving affordability and access to gene therapies, infusible cancer drugs and other medications administered in a clinical setting.
List prices of 450 medications have increased 5% overall at the beginning of 2023. More price hikes are expected.
CT-P13 SC is a subcutaneous formulation of Celltrion’s Inflectra, a biosimilar of Remicade. The BLA seeks approval to treat patients with inflammatory bowel disease.
Wegovy is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.
Hospira is calling one lot of vancomycin hydrochloride, an antibiotic to treat patients with serious infections caused by methicillin-resistant staphylococci.
If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.
An integrated approach helped Regence drive conversion to biosimilars with a 95% member utilization.
Olpruva is a new formulation of sodium phenylbutyrate to treat patients with urea cycle disorders, a genetic condition that causes ammonia to build up in the blood.
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