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.
The U.S. FDA cleared respiratory imaging technology company 4dmedical Ltd.’s computed tomography lung ventilation analysis software (CT LVAS) that is nearly identical to its X-ray velocimetry technology but uses CT imaging and provides greater access to the four-dimensional imaging technology.
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions.
The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.
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