From WisPolitics.com/WisBusiness.com …
— The FDA has accepted a drug submission from NorthStar Medical Radioisotopes, the Beloit company announced, touting the “critical regulatory milestone” for its nuclear medicine product.
The business yesterday said the federal agency has accepted its Type II Drug Master File submission for its no-carrier-added Actinium-225, noting this “formally establishes” this product for use in developing radiopharmaceutical drugs.
The acceptance also helps “streamline” the regulatory pathway for various applications including cancer treatment, according to the announcement.
NorthStar President and CEO Dr. Frank Scholz says the FDA’s acceptance along with the company’s manufacturing capabilities “establishes NorthStar as a regulatory-ready and operationally proven supply partner for targeted alpha therapies.”
See the release below.
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— Elephas Biosciences Corporation is working with a California company called Mithrl to incorporate AI into its tumor profiling platform.
The Madison business today announced the scientific collaboration with the tech firm, applying its “scientific decision engine” to the Elephas elive platform. This inclusion of AI analysis aims to improve its ability to identify immunotherapy response signals, according to the release.
“We’re incredibly impressed with the speed at which Mithrl is able to generate novel insights that can better understand the biology of response and generate insights that may help guide translational research and therapeutic development,” Hinco Gierman, chief scientific officer for Elephas, said in a statement.
See the release below.
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Press Releases
– NorthStar: Secures FDA acceptance of drug master file for no-carrier-added Actinium-225
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