The FDA has released what it calls a regulatory framework to promote and accelerate development of effective regenerative medicine therapies while cracking down on businesses that market inadequately tested procedures that the government says can put patients at risk. The new rules specify the processing protocols that will trigger FDA oversight and outline a framework for advancing development of promising cell and genetic therapies. "With this balanced approach, we're well positioned to support and help advance breakthrough science, like regenerative medicine, and promote responsible and flexible regulation that leverages science to advance public health," FDA Commissioner Scott Gottlieb said in a statement.
Two studies presented at the annual meeting of the American Academy of Ophthalmology detailed how retinal pigment epithelial cells derived from embryonic stem cells were transplanted into patients' eyes to treat retinal degeneration. Although the work was not designed to assess efficacy, researchers said they detected early indications of improved visual acuity, and there were no safety problems associated with the transplanted cells themselves.
The chimeric antigen receptor T-cell therapy developed as a multiple myeloma treatment by bluebird bio and Celgene, known as bb2121, has received breakthrough status from the FDA and PRIME status from the European Medicines Agency. The early-stage trial for bb2121 is ongoing and scheduled for completion in December 2018.
HIV infection rates in 31 European countries are rising among older patients, according to a study by the European Center for Disease Prevention and Control, but it's not clear if the findings reflect a true increase or are due to better diagnosis and data reporting. The researchers documented 54,102 new cases of HIV between 2004 and 2015 among people ages 50 and older, and diagnoses increased 2.1% annually on average over the study period.
Initial data from Fate Therapeutics' trial assessing the efficacy of its drug candidate FATE-NK100 as a treatment for relapsed/refractory acute myelogenous leukemia were reported at the annual meeting of the Society for Immunotherapy of Cancer. Data showed members of each of the trial cohorts experienced anti-leukemic activity when treated with the agent.
The first clinical trial site has been activated for Trovagene's Phase Ib/II acute myeloid leukemia trial to evaluate its lead candidate PCM-075. The trial will do enrollments for relapsed/refractory AML patients who have received no more than three previous treatments.
The number of confirmed cases of dengue in India has reached 8,063, with 4,188 of those located in Delhi. Indian health officials also reported that the number of recorded cases of malaria as of Saturday stands at 1,106, while the number of chikungunya cases has reached 855.
Aidan Hooper of Edmond, Okla., died in an accident when he was 8 years old. Aidan, whose donated heart valves gave lives to two young girls, will be honored as a tissue donor in the 2018 Tournament of Roses Parade.
A study evaluating wait-listing for 1,057 patients who were referred for kidney transplant evaluation found African-American patients were less likely than white patients to be wait-listed for transplant, and wait-listing was positively associated with income, transplant knowledge and having a live donor. Wait-listing was negatively associated with factors including age, comorbidities, being on dialysis and low socioeconomic status, researchers reported at the American Society of Nephrology annual meeting.
A review in the journal Hepatology found that patients coinfected with hepatitis C virus and HIV experienced sustained virologic response (SVR) at similar rates after treatment with direct-acting antiviral therapies as patients infected with HCV alone. In contrast, coinfected patients assigned to interferon-based treatment were less likely to achieve SVR than monoinfected patients.
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