FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
September 16th 2023Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
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Peterson Health Releases Framework for Digital Assessments
September 14th 2023The assessment framework developed by Peterson Health Technology Institute and the Institute for Clinical and Economic Research will prioritize products’ clinical benefits and economic impact of digital health technologies. The companies will announce the first set of health technologies to be reviewed by mid-October.
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Dr. Benjamin Rome Discusses Ways to Address High Drug Prices
September 13th 2023Addressing drug affordability and accessibility will involve tackling the interrelated problems of high prices and problematic pharmacy benefit manager practices, says Benjamin N. Rome, M.D., with Brigham and Women’s Hospital in Boston.
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Generic Triumeq PD, a First-line HIV Medication For Children, Gets Tentative OK
September 12th 2023The tentative approval by the FDA is through the President’s Emergency Plan for AIDS Relief (PEPFAR) program and is supposed to ease regulatory authority submissions, production and distribution in low- and middle-income countries.
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Patient, Provider Support is Key for Biosimilar Adoption| 2023 PBM I Annual National Conference
September 8th 2023There is a huge opportunity for savings from the recently launched Humira biosimilars and others expected to reach the market in the next few years. But plans and PBMs will need to step into the role that pharmaceutical manufacturers once did in supporting patients and prescribers.
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Scripius Removes Dupixent from Formulary
September 7th 2023The decision by Scripius (previously Select Health Prescriptions) was made based on the cost of Dupixent, as well as because of an increased demand to use Dupixent for mild atopic dermatitis when the primary patient population is those with moderate to severe disease.
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Strategies for Paying for Gene and Cell Therapies | 2023 PBMI Annual National Conference
September 7th 2023As cell- and gene-based therapies become available for new and expanded indications with a higher incidence of patients, payers will be challenged to find ways to provide access to patients.
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FDA Updates for the Week of Aug. 28, 2023
September 2nd 2023The FDA has approved Reblozyl as first-line treatment in MDS-related anemia and the first generics of ADHD drug Vyvanse. The agency also issued a CRL for bevacizumab to treat wet AMD. Additionally, two companies have submitted supplemental applications. These include Janssen, which is seeking full approval for Balversa for urothelial carcinoma, and AbbVie, which is seeking approval of Skyrizi for ulcerative colitis.
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A New Stem Cell Approach Offers Hope for Those with Chemical Eye Burns
August 31st 2023Researchers at Mass Eye and Ear and Dana-Farber Cancer Institute have developed a new technique for growing stem cells harvested from the eye that meets the FDA’s regulatory requirements for tissue engineering.
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FDA Updates for the Week of Aug. 21, 2023
August 26th 2023The FDA has approved the first biosimilar of MS drug Tysabri and granted additional approvals to Abrysvo to prevent RSV in infants, to a higher dose Eylea, and to Ingrezza for a disorder associated with Huntington’s disease. The agency has also set a review date for first-in-class therapy for MDS and granted priority review to Xtandi for earlier treatment in prostate cancer.
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