PBM Exclusions Increasing, Finds New Analysis
June 7th 2022Xcenda’s review of the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—finds they are excluding medicines in classes where generics are not available or for serious conditions, such as oncology and autoimmune disorders.
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FDA Updates for Week of May 31
June 4th 2022The FDA has withdrawn the approval of Ukoniq, which is used to treat two specific types of lymphoma. In approvals, the regulatory agency has approved a new indication for Kymriah, two addition Opdivo regimens, and extended the use of Evrysdi in newborns with SMA. The agency also accepted for review Dupixent to treat skin lesions but extended the review of a new ALS therapy, refused to file an application for a rare metabolic disorder, and put a hold on the trial for Cialis OTC.
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Therapy for Age-Related Blurry Vision Shows Positive Results
May 31st 2022If approved, Orasis’ low-dose pilocarpine would be the second product that improves presbyopia, which is the age-related loss of clear up-close vision. The company plans to submit an NDA in the second half of the year.
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FDA Update for Week of May 23, 2022
May 28th 2022The FDA has approved the first non-steroid cream for psoriasis, as well as another biosimilar of Neulasta, Tibsovo combination for older patients with leukemia and a new formulation of Tyvaso. The agency has issued a second CRL for poxvirus treatment and also accepted applications for several therapies, including a nasal spray for migraine, mirvetuximab for ovarian cancer, and a treatment for the rare disease Friedreich’s ataxia.
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FDA Updates for the Week of May 16, 2022
May 21st 2022In COVID-19 news, FDA expanded EUA for Pfizer/BioNTech COVID-19 booster to children 5 to 11 years and cleared first at-home combo COVID-19, RSV and flu test, but declined an EUA for the antidepressant fluvoxamine to treat COVID-19. Regulators also approved Lilly’s novel diabetes drug and Dupixent eosinophilic esophagitis, modified Dsuvia REMS program and issued a CRL for bimekizumab for psoriasis.
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Aetna Adds Recently Approved Drugs to Precertification List
May 18th 2022Aetna has made available four specialty drugs that were approved early in 2022 through prior authorization. These include a biosimilar, a CAR-T immunotherapy, and therapies for macular degeneration and a rare auto-immune disease.
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FDA Updates for Week of May 9, 2022
May 14th 2022In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.
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