Denise Myshko

It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.

Blue Shield is replacing CVS Caremark with Prime Therapeutics as the company that will negotiate with drug manufacturers beginning in January 2025. The insurer is also teaming up with Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.

The FDA has approved Talvey, a new therapy for treating multiple myeloma patients. The agency has also issued a complete response letter for avasopasem for severe oral mucositis and set a PDUFA date for a monthly MS drug.

FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.

The newly formed Peterson Health Technology Institute was launched with $50 million to analyze clinical benefits and economic impact of new health technologies.

ABBV-RGX-314 delivers a gene encoding a therapeutic antibody fragment to inhibit vascular endothelial growth factor (VEGF). Early results show it is well-tolerated and leads to improved disease.

Patients with geographic atrophy and their caregivers would benefit from support and accommodations related to managing daily life activities and social activities, as well as their mental health, Sophie J. Bakri, M.D., said during her presentation

FDA approvals this week include the second nonprescription naloxone nasal spray for opioid overdose, the first drug for a skin infection from pox virus and a drug to treat an eye infection caused by mites. In addition, the FDA has accepted a supplemental application for Ofev in children with rare lung disease.

Mental health issues have impacted minorities and at-risk groups the highest. But a new analysis has found that disparities exist within at-risk populations.

The FDA has cleared several new products this week, including the first monoclonal antibody for RSV in infants, a novel therapy for newly diagnosed patients with AML and a postexposure anthrax vaccine. Additionally, an FDA decision on donanemab for Alzheimer’s is expected by the end of this year.

Approvals this week include Opill, the first nonprescription oral contraceptive, the use of Veklury for COVID-19 in patients with severe renal impairment, and the earlier use of Leqvio for in heart disease. In addition, Takeda pulled its application for a dengue vaccine.

This week, the FDA granted full approval to the Alzheimer’s drug Leqembi, set an action for review of zolbetuximab to treat gastric cancers and rejected Amneal’s new drug application (NDA) Parkinson’s disease treatment.

Approvals this week include: a $2.9 million gene therapy for hemophilia A; a pediatric growth hormone; the first cell therapy for type 1 diabetes; a new alopecia drug; a therapy for generalized myasthenia gravis; and full approval for Blincyto in B-cell ALL. The agency also rejected a higher dose of Eylea and set an action for hemophilia B gene therapy.

The FDA’s approvals this week include: a $3.2 million gene therapy, the first anti-inflammatory drug for cardiovascular disease, a subcutaneous version of Vyvgart for myasthenia gravis and Jardiance and Synjardy for kids with type 2 diabetes. Three rejections by the agency include: a therapy for NASH, for retinal cancer, and for rare fungal infections. In addition, Geron has submitted an NDA for first-in-class therapy for MDS.

New analyses shed light on decreased hearing in people with Graves’ disease and thyroid eye disease.

PBMs have imposed accumulators and maximizers to counteract pharma’s copay assistance programs. Drug manufacturers have retaliated by reducing the amount of patient assistance available.

The FDA has approved a second bispecific antibody to treat patients with diffuse large B-cell lymphoma, as well as Linzess to treat children with constipation. Additionally, an FDA advisory committee recommends approval of Sanofi/AstraZeneca’s RSV vaccine for infants.

The FDA has made three approvals this week: a novel drug for dry eye disease, a new indication for Prevymis to prevent CMV disease in adult kidney transplant recipients, and another prostate cancer indication for Lynparza. The agency has also set target action dates for the first CRISPR gene edited therapy and a supplement indication for Jemperli for earlier treatment of endometrial cancer. Additionally, Janssen submitted sBLA for Carvykti for early treatment of myeloma.

The FDA has approved two novel therapies for patients with dry eye disease: Vevye (previously CyclASol) is a water-free, preservative-free solution, and Miebo, which address the excessive tear evaporation that is seen with dry eye.

Inpefa (sotagliflozin) added 0.39 quality of life years at an incremental lifetime cost of $29,449 for an incremental cost-effectiveness ratio of $75,510 per quality-of-life year gained, according to the study that was sponsored by the drug's maker, Lexicon Pharmaceuticals.

FDA approvals this week include: novel treatment for invasive candidiasis, an accelerated approval to Zynyz for Merkel cell carcinoma, the high-concentration Humira biosimilar Hyrimoz, and extension of Evkeeza’s indication to include young children. The agency also issued two complete responses this week: for Incyte’s extended-release Jakafi and for AbbVie’s Parkinson’s therapy.

American Indian and Alaska Native had increased access to diabetes treatment services, which lowered hyperglycemia and blood lipid levels, as well as diabetic retinopathy incidence.

The discovery of a protein that determines levels of vascular endothelial growth factor-A (VEGF) could lead to new therapies for macular degeneration, diabetic retinopathy and other common causes of vision loss.

In his keynote at the annual meeting of the American Academy of Dermatology Association Safi R. Bahcall, Ph.D., a physicist and entrepreneur, spoke about how seemingly crazy ideas can lead to breakthroughs.

VISIBLE is focused on answering data gaps in people of color with psoriasis. Lead investigator Andrew F. Alexis, M.D., hopes the study will generate data to help address care gaps and inform future best practices in diversity research in dermatology.

Checkpoint inhibitors, such as Keytruda (pembrolizumab) and Opdivo (nivolumab), are playing a major role in cancer treatment. But they also produce side effects that affect the skin. Steven Chen, M.D., M.P.H., M.H.P. Ed., said dermatologists need to work with oncologists to manage the side effects so patients can stay on checkpoint inhibitors.

Longer-term use of Opzelura was well tolerated, with no serious treatment-related adverse events, according to a poster presented at the annual dermatology meeting.

Women who are pregnant don’t have to stop all of their treatments during pregnancy. Some can be safely treated for their psoriasis or eczema, according to a presentation today at the annual meeting of the American Academy of Dermatology.

Research shows that short-term exposure to wildfire air pollution can affect the skin and cause flares of certain skin conditions.

After initial treatment, Opzelura used on an as-needed basis was able to control symptoms of atopic dermatitis and helped patients sleep, according to a poster presented at the annual dermatology meeting.