Ryan Flinn

IO Biotech plans to meet with the FDA this fall to discuss the data from the phase 3 trial of Cylembio and determine next steps for a potential biologics license application submission.

CMS is brokering outcomes-based agreements on behalf of Medicaid programs. Thirty-three states, along with Washington, D.C., and Puerto Rico, have signed on, collectively covering about 84% of Medicaid enrollees with sickle cell disease.

The response rate to Amtagvi was higher in patients who had received two or fewer therapies than in those with more heavily treated disease.

Studies show in mice show that targeting the metabolic pathways could inhibit the growth of melanoma and combining this strategy with other treatments could enhance the therapeutic effect.

All 10 participants in this trial showed improvements in hearing within the first month of receiving the gene therapy, which delivered healthy copies of the OTOF gene.

The eavesdropping artificial intelligence saves physicians time and means more eye contact during patient visits.

FDA officials have determined that information regarding the risks for six CAR T-cell therapies can be communicated through product labeling, which includes a boxed warning for the risks of cytokine release syndrome and neurological toxicities.

Most gene therapies being studied for eye diseases are in earlier phases of development, and a third of the gene therapies being investigated are for age-related macular degeneration.

When available, the educational toolkit will provide patients with sickle cell disease information on the gene therapy process, what to expect from therapy, and the importance of follow-up care.

EGFR inhibitors such as Erbitux and Gilotrif show potential in laboratory and mouse studies in treating melanoma with a specific mutation that can lead to resistance to immunotherapy.

AI apps that can detect skin cancer can be manipulated and potentially miss cases of melanoma, a serious skin cancer.

While heritable human genome editing is banned in the United States, across Europe and much of the world, the technology raises concerns about potential misuse.

Several oral abstracts presented at the American Society of Clinical Oncology’s annual meeting highlight ongoing research of Keytruda, Opdivo, Tecentriq and more in skin cancer.

A personalized gene editing therapy was successfully used to treat an infant with CPS1 deficiency, a disease that causes ammonia buildup in the blood. The technology used creates an opportunity for the development of personalized treatments for other rare diseases.

Healthcare providers expressed concerns about the accuracy gaps in AI image analysis for non-white skin tones or low digital literacy, creating potential health disparities.

Healthcare providers are exploring ways to reduce patient travel through a growing trend of expanding sites of administration beyond academic medical centers into community and outpatient settings closer to patients' homes.

Patients who were positive for cytomegalovirus had more immune cells circulating in their blood before they started immunotherapy. This may be one reason why these patients responded better to certain immunotherapy treatments, researchers said.

Plans expect cell and gene therapies to pose a moderate or major financial challenge in the next two to three years, according to a new survey of pharmacy benefit leaders by PSG.

In mice with human Merkel cell carcinoma, pyrvinium pamoate significantly reduced tumor growth, potentially offering a new way to treat this aggressive skin cancer.

A phase 1b showed promising results in lowering LDL in patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease.

A new study suggests that targeting the protein alpha-synuclein could be a possible new target for treating melanoma.

Lexeo Therapeutics’ gene therapy provides a healthy version of the frataxin gene, which is critical for energy production in cells. The company plans to begin a pivotal trial next year.

Patients with a rare disease called mucous membrane pemphigoid are at risk of developing squamous cell carcinoma and basal cell carcinoma, finds a new study.

None of the cell and gene therapies that reached the final regulatory submission stage were rejected by the FDA.

The Map My Mole app provides patients with a small lens attachment for their phones to capture high-quality images of concerning skin spots. These images are then uploaded for assessment by consultants.

Encelto is small, semi-permeable capsule implanted in the eye that contains allogeneic retinal pigment epithelium cells genetically engineered to produce specific therapeutic proteins. It will be available in June 2025.

EsoBiotec’s platform has the potential to eliminate the complex and time-consuming process for manufacturing, helping to make CAR-T cell therapies more accessible.

Early research shows a one-time gene therapy has potential for addressing both the liver and lung disease that patients with alpha-1 antitrypsin deficiency (AATD) face.

Researchers said alpha particles are promising therapies that target cancer while minimizing the damage to nearby healthy tissues.