Xipere became commercially available in March 2022. It is the first therapy for patients with macular edema that provides a targeted delivery to the retina.
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A study in the journal Blood has found that the cost-effectiveness of the Polivy treatment regimen used to treat patients with diffuse large B-cell lymphoma would decrease if the five-year progression-free survival decreased.
Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.
Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.
Committee members said the data from the two trials submitted didn’t support efficacy of Nuplazid in Alzheimer’s patients. The PDUFA target date is Aug. 4, 2022.
Walgreen’s patient insights and technology capabilities, along with partner healthcare companies, will aim to engage broader and more diverse communities for participation in clinical trials.
On June 15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of both vaccines.
This is the third approval for Skyrizi, which also treats psoriatic arthritis and plaque psoriasis.
The FDA also issued a complete response letter for Imcivree for use in patients with Alstrom syndrome, another genetic rare disease that can cause obesity.
The Federal Trade Commission said that paying or accepting rebates or fees in exchange for excluding lower cost drugs on formularies could be considered commercial bribery.
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A literature review by AmerisourceBergen's Xcenda identifies a link between high cost sharing and patient nonadherence to medication regimens.
The committee recommended Moderna’s and Pfizer’s COVID-19 vaccines were recommended for children 6 months to five years, as well as Moderna’s vaccine for children ages 7 to 16.
Genentech’s anti-amyloid crenezumab did not slow or prevent cognitive decline in people with early-onset Alzheimer’s disease.
Joe Murad, president and CEO of the pharmacy benefit manager WithMe Health, talks about how consumer-driven healthcare requires access, transparency, and easier navigation.
Researchers writing in Health Affairs have found that new patents for updated devices have delayed generic competition in asthma and COPD treatments.
But investigators found that U.S. approvals often come before publication of results.
A generic is available for one, and Centers for Medicare & Medicaid Services has removed two others from Medicare Part D coverage.
Amvuttra is expected to launch in July, and the developer, Alnylam, plans to make this available through value-based agreements.
Olumiant is the first systemic therapy available to treat alopecia.
The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.
In February 2022, the FDA had issued a complete response letter in order to inspect a new third-party packaging and labeling facility.
The FDA has set a PDUFA date of Jan. 29, 2023, but Merck indicated additional data may be provided to regulators that extends this date.
If approved, beti-cel will be the first potentially curative gene therapy for people with beta-thalassemia who require regular red blood cell transfusions. The PDUFA date is Aug. 19, 2022.
If approved, elivaldogene autotemcel will be the first gene therapy to address the underlying genetic cause of cerebral adrenoleukodystrophy, a rare disease that affects young boys.
Efanesoctocog alfa is a new class of factor VIII therapy with once-weekly prophylactic dosing. The application for approval expected to be filed mid year.
The recalls were made because the medications failed sterility testing.
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