Xipere is delivered via an injection to the back of the eye to treat macular edema associated with uveitis, a form of eye inflammation.
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Specialty medicines are now 53% of spending, up from 27% in 2010 and driven by growth in autoimmune and oncology therapies.
Genentech’s Susvimo is a refillable implant that delivers medication continuously for up to six months.
Oncopeptides will close down its business units in the United States and Europe to focus exclusively on being a Sweden-based R&D company.
Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.
A phase 3 trial of Pfizer and BioNTech’s COVID-19 vaccine booster demonstrates an efficacy rate of 95.6%.
If a patient does not remain on the drug for at least three months due to effectiveness or tolerability, a significant portion of the drug cost will be refunded to Point32Health.
Tecentriq is the first cancer immunotherapy available for adjuvant treatment of non-small cell lung cancer (NSCLC).
Treating and managing patients with paroxysmal nocturnal hemoglobinuria is expensive and requires constant surveillance by the provider and health plan.
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Dr. Reddy’s received FDA approval for two strengths of lenalidomide for the treatment of patients with multiple myeloma.
AmerisourceBergen/Xcenda survey finds payers believe biosimilars provide costs savings, and they are expected to continuing contracting with manufacturers.
Glass was found in one vial of Cubicin, which treats patients with Staph infections of the skin and blood.
Express Scripts will put the first interchangeable biosimilar insulin on its National Preferred Formulary and exclude Lantus, the reference product.
COVID-19 travel restrictions have hindered the FDA’s ability to inspect European manufacturing facilities for bimekizumab, which is under review for the treatment of patients with psoriasis.
ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.
Most of the solutions have established systems to track patient outcomes over time, and several include performance guarantees as part of their solution.
This low-dose formulation of Biktarvy is for younger children living with HIV.
Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.
The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.
Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.
The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.
Boehringer Ingelheim will make Cyltezo available when its commercial license begins on July 1, 2023.
The committee’s two-day meeting resulted in recommended approvals for both J&J’s and Moderna’s COVID-19 booster.
Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.
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