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In a busy week for FDA approvals, the agency cleared several first in class therapies: a treatment for HIV-1 and for follicular lymphoma. Other approvals include: Tymlos for osteoporosis in men; Vraylar for major depressive disorder; Cytalux to identify lung cancer during surgery. In COVID-19 news, the agency approved Actemra for hospitalized patients. The FDA has also accepted a sBLA for Padcev, Keytruda combo for urothelial cancer.

COVID-19 remained to be a hot topic among readers of MHE as it is still affecting thousands, weekly. Articles about COVID-19 that were most-read by our audience resulted with the effects of Paxlovid at the top to the the BA.5 variant.

Amendola Communications collected 10 predictions for developments in healthcare in 2023 from leaders in the field.

We can identify and engage the right people. But to make a real difference in any community, a managed care organization, government agency or healthcare system needs to have a robust list/dataset of its population so the tools, processes and individuals that come after can do the work to identify and engage members with the highest needs.

In COVID-19 news, the FDA granted fast track designation to COVID-19-flu vaccine combo. The FDA has approved the first gene therapy for bladder cancer, an 8th biosimilar referencing Humira, granted accelerated approval for KRAS-mutated lung cancer therapy, and approved Iyuzeh to reduce intraocular pressure. The agency also extended review of Lynparza/abiraterone combination for prostate cancer. In addition, two companies have submitted applications: Soligenix for a novel therapy for cutaneous T-cell lymphoma and AbbVie for Linzess in children and adolescents.

In COVID-19 news, the FDA has expanded the updated bivalent vaccines EUA to children. The FDA has requested athe removal of Pepaxto indication for multiple myeloma. Regulators have also accepted several applications for: Biogen’s Actemra biosimilar, Pfizer’s RSV vaccine, a resubmitted BLA for Fabry disease. Two companies — Janssen’s and Alnylam — have submitted new applications.

This week, the FDA made two approvals, the first-ever microbiota product and a second indication for Brexafemme, and issued a CRL for a therapy for brain metastasis from neuroblastoma. The regulatory agency also granted priority review for a Duchenne gene therapy, and accepted three applications: for a cutaneous T-cell lymphoma therapy, for an antibiotic for drug-resistant infections and Evkeeza for children with rare high cholesterol. Additionally, Genentech has withdrawn Tecentriq’s indication for bladder cancer and Aldeyra has submitted an NDA for the novel dry eye therapy reproxalap.

Short-term manufacturing problems are happening as the demand for Adderall and other stimulant medications for ADHD have increased. Data from Arrive Health show a marked increase in ADHD medication prescriptions for people in their 30s.

What does it take for a healthcare organization to effectively expedite and achieve a digital transformation? Start with the fundamentals, like having an integrated transformation strategy with clear goals across the enterprise, highly visible and vocal top-down leadership, and exceptional tactical talent for implementation.