News

In COVID-19 news, the FDA has declined an EUA request for Zyesami and Pfizer has submitted NDA for Pavlovid. The regulatory agency has accepted several applications, including an sBLA for Eylea in diabetic retinopathy and the NDA for palovarotene for a rare genetic disorder. The FDA also issued a CRL for a UTI therapy and extended the review of diabetes therapy. And finally, Gilead has resubmitted its twice-year HIV therapy.

By using a combination of predictive and prescriptive next best action insights, providers can close the gap in care for individual patients by leveraging a combination of data sources — clinical data, patient surveys, SDOH data, and consumer and behavioral data sets — and applying artificial intelligence techniques to create those insights.

The Association for Community Affiliated Plans has launched The ACAP Center for Social Determinants of Health Innovation. The center offers tailored resources, including policy reports, market research, and roundtable educational events, to help health plans, policymakers, and other stakeholders address social issues that impact health and wellbeing

FDA approves tumor-agnostic cancer therapy, Clovis pulls Rubraca indication, Purdue launches opioid reversal, FDA plans advisory committee meeting for Xphozah, and Manarini and AbbVie submit applications.

Demand for birth control obtained through telehealth or without a prescription continues to grow, and some states have loosened up their rules. Meanwhile, groups and organizations involved in contraception are bracing themselves for the effects of the U.S. Supreme Court decision today overturned Roe v. Wade and the constitutional right to abortion.

In COVID-19 news, the FDA expanded emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age. The FDA also approved Skyrizi for Crohn’s disease, Olumiant for alopecia, as well as two rare disease therapies: Imcivree for obesity associated BBS and Amvuttra for neuropathy associated with rare disease. Additionally, FDA extended the PDUFA date Brukinsa.

In COVID-19 news, an FDA advisory committee recommends EUA for Novavax’s vaccine. The FDA has also granted approvals to Dupixent for children as young as 6 month with atopic dermatitis and to the biosimilar Riabni for rheumatoid arthritis. An advisory committee has also recommended approval for two gene therapies, one for a rare neurogenerative disease and another for a blood disease.

The commission will review PBM business practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement.

The Federal Trade Commission says its inquiry “will shed light on” clawbacks, potentially unfair audits, rebates and other business practices of the pharmacy benefits management (PBM) industry. Today’s announcement says the commission will be requiring information from the six largest PBMs.