“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
Reports of T-cell malignancies, including lymphoma, have the U.S. FDA investigating the risks for patients who received certain autologous CAR T-cell immunotherapies.
With drug shortages becoming a fact of life, U.S. President Joe Biden said he plans to issue a presidential determination to broaden the Department of Health and Human Services’ (HHS) authorities under the Defense Production Act to enable investment in the domestic manufacturing of essential medicines, medical countermeasures and other critical inputs that the president deems essential to the national defense.
Springworks Therapeutics Inc.’s nirogacestat became the first drug indicated specifically for desmoid tumors, as well as the first gamma-secretase inhibitor to win marketing approval, winning a U.S. FDA nod on the anticipated PDUFA date of Nov. 27. Branded Ogsiveo, nirogacestat has breakthrough therapy, fast track and orphan designations.
Inflammatix Inc. received U.S. FDA breakthrough device designation for its Triverity acute infection and sepsis test system, which produces three readouts that could help emergency physicians quickly determine the proper course of treatment.
Awak Technologies Pte Ltd. gained the U.S. FDA’s breakthrough designation for an artificial intelligence (AI)-based kidney disease progression prediction (KDDP) model on Nov. 27, following its $20 million fundraising that marked one of Singapore’s largest med-tech financings in 2023.
With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in the high list prices facing American patients.
Smith+Nephew plc struck a deal to acquire Cartiheal Ltd. for $180 million at closing and $150 million in contingent payments, seven months after Bioventus Inc. backed out of its agreement to buy the developer of the Agili-C cartilage regeneration platform for $450 million.
The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
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