The U.S. FDA is promising to make 2024 a “breakout” 12 months for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. “This is a great year to focus on gene therapy,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “I just want to focus on moving ahead gene therapy,” he told attendees of the J. P. Morgan Healthcare Conference on Jan. 8.
The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
Privacy laws and enforcement in the U.S. are seemingly growing by the week on both the state and federal levels, with the Federal Trade Commission (FTC) serving as one of the players in the federal enforcement game. The FTC has released a statement warning developers of data that are working as model-as-a-service companies to be wary of any illicit uses of data acquired to assist in development of artificial intelligence algorithms, a warning that these developers and their customers would do well to heed.
Ultromics Ltd. joined forces with Pfizer Inc. to expedite U.S. FDA clearance of its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis, also known as stiff heart syndrome. The company received FDA breakthrough device designation last year for Echogo Amyloidosis, which uses deep AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, a serious condition often missed during standard heart assessments.
Listening to conversations between a mother and her unborn child on the cellular level could inform how the pregnancy is going and prevent complications. Three scientific groups from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in collaboration with Wayne State University and Michigan State University, have used single-cell RNA sequencing techniques to decipher these words, identify the cellular language of these interactions in the placenta and establish a cellular atlas.
California’s First District Court of Appeal opened an avenue, in that state at least, for lawsuits against drug and device companies based on their pipeline development priorities.
Industry may still be less than fond of the failure of the term “recall” to distinguish between corrections and market withdrawals, but the class I recall of the Insulet Omnipod 5 app for Android smartphones is a correction of some importance. This recall, one of the first to be announced by the FDA in 2024, addresses a software problem that could lead to overdose of insulin, a potentially lethal problem for which the company has already provided a fix.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
The U.S. FDA granted breakthrough device designation to CG Bio Co. Ltd.’s spine implantation device, Novosis putty, making it the first bone substitute material developed in South Korea to gain the agency’s priority support. Novosis putty, successor to CG Bio’s first generation Novosis Ortho, combines a bone-forming protein called recombinant human bone morphogenetic protein 2 (rhBMP-2; Nebotermin) with ceramic scaffolds to accelerate bone growth.
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