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AATB NEWS
Happy Holidays From AATB
As 2022 comes to a close, AATB would like to wish its members, partners and other industry professionals a safe and happy holiday season. As we reflect on the past year for the industry, we would like to provide the readers of the AATB NewsBrief a look at some of the most accessed articles from the year. Our regular publication will resume Wednesday, January 4.
NEWS FROM THE FIELD
Overworked and Ready for Expansion: FDA's Cell and Gene Therapy Office Preps to Add About 100 New Positions
Endpoints
The need for the FDA's Office of Tissues and Advanced Therapies has grown tremendously. As a result, OTAT is looking to add around 100 more employees. FDA Uncovers Additional Types of Cancer Possibly Linked to Breast Implants
Fierce Biotech
It is believed to be rare, but the FDA has discovered cancers linked to scar tissue and fluid around breast implants. With Help From Maryland Families, Scientists Find Overlooked Genes for Autism
The Baltimore Sun
In SPARK, the longest running autism study in the U.S., there are medical records of 275,000 people which were used to identify new genes influencing autism in 43,000 people. Classic and Current Opinions in Human Organ and Tissue Transplantation
Cureus
Advances in tissue transplantation involve awareness of molecular mechanisms that underpin the respective immunopathology involved and the design of precision medicines that are safe and effective. Industry Groups: Expand FDA’s RTOR Guidance to Cell and Gene Therapies
RAPS Regulatory Focus
Industry groups are asking for more clarity on how the FDA's draft guidance would apply to cell and gene therapies. Number of Organs Donated, Eligible Donors Fell Nearly 30% in Both Waves of the Pandemic
Healio
During the first year of the pandemic, there were fewer in-hospital deaths associatied with organ donation. However, that also means there was a decline in the number of donated organs and eligible donors. Allograft May Be an Option for Traumatic Peripheral Nerve Injury Repairs in Children
Healio Orthopedics
In results presented at the American Society for Surgery of the Hand Annual Meeting, an observational study showed 18 patients with successful allograft reconstruction procedures treating 24 nerves. Their pain levels were reported at 4 or lower using the Wong-Baker faces scale for pain. 5 Lupus Patients in Remission Following CAR T Cell Therapy
BioSpace
In a study published in Nature Medicine, five patients who underwent CAR T treatment remained in remission for eight months on average without the need for other drugs help reduce symptoms. Repeat COVID-19 Infections: Significantly Increased Risk of Organ Failure and Death
SciTechDaily
Researchers from Washington University School of Medicine in St. Louis and the Veterans Affairs St. Louis Health Care System found that multiple COVID-19 infections can contribute "substantial additional risk" across different organ systems.
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