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.
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 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.
Are there other guidances the U.S. FDA should release as final without going through the draft and public comment process first? That’s one of the questions the FDA wants stakeholders to comment on as it updates its best practices for guidance.
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.
Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.
The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts.
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