Pearsanta Inc., a subsidiary of Aditxt Inc. formed in Feb. 2023, acquired MDNA Life Sciences Inc. for $25 million in stock, marking Aditxt’s second deal announced in a month. The company moved into the women’s health market with the $100 million planned acquisition of Evofem Biosciences Inc., maker of the contraceptive gel Phexxi, which it reported on Dec. 12.
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
