FierceBiotech

UPDATED: FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
STAT

FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...
The American Journal of Managed Care

FDA Proposes New Approval Pathway for Individualized Ultra-Rare Disease Therapies

FDA proposes using a well-supported mechanistic rationale plus natural history comparators to generate substantial evidence when randomized trials are infeasible for ultra-rare populations.
Psychology Today

Why Scratching Itches and Grabbing Injuries Reduces Discomfort

When I was a kid, my mom would say, “Don’t scratch that itch, it will only make it worse.” And multiple elementary school teachers told me, “Holding an injury doesn’t help. Leave it alone.” But it ...
WAFF

City of Owens Cross Roads releases statement addressing Pathway facility

OWENS CROSS ROADS, Ala. (WAFF) - The City of Owens Cross Roads released a statement addressing the Pathway facility. Owens Cross Roads City Council voted in November to pursue legal action toward the ...
Business Wire

Pathway to Deliver New Class of Adaptive and Continuously Learning AI Systems with AWS and NVIDIA Technologies

Pathway’s post-transformer architecture BDH integrated with NVIDIA AI and AWS cloud infrastructure Pathway model’s continuous learning, efficiency, and live observability is powered by NVIDIA AI ...
The Business Journals

Pathway Lending launches $30M fund to preserve affordable housing

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min Pathway Lending launched a $30 ...
FierceBiotech

UPDATED: Prasad, Makary unveil new FDA path for accelerating custom gene editing therapies

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...
Reuters

Clearlake to buy investment manager Pathway Capital in private markets push

Nov 12 (Reuters) - Clearlake Capital Group said on Wednesday it will buy investment manager Pathway Capital Management, as the buyout firm looks to expand its presence in the red-hot private markets ...
Reuters

US FDA unveils new pathway to approve personalized therapies

NEW YORK, Nov 12 (Reuters) - The U.S. Food and Drug Administration can approve new personalized treatments for rare and deadly genetic diseases based on data from a handful of patients, two of the ...
WHNT

Owens Cross Roads City Council to discuss future of Pathway facility on Thursday

OWENS CROSS ROADS, Ala. (WHNT) – A special city council meeting will take place in Owens Cross Roads on Thursday to discuss the future of the Pathway of Madison County facility. The facility for ...