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T cells
Immuno-oncology

Context’s CTIM-76 cleared to enter clinic for CLDN6-positive cancers

May 3, 2024
Context Therapeutics Inc. has received FDA clearance of its IND application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.
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Website of The Federal Trade Commission

US FTC’s breach notification draws fire from dissenting commissioners

May 2, 2024
By Mark McCarty
The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR.
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Ocular

FDA accepts IND for Eluminex’s EB-105

May 2, 2024
Eluminex Biosciences Ltd. announced the FDA’s acceptance of their IND application for EB-105, a trispecific fusion antibody targeting vascular endothelial growth factor A (VEGF-A, and isomers), VEGF-B, placental growth factor (PlGF), angiopoietin-2 (Ang-2) and interleukin-6 receptor (IL-6R) for the treatment of diabetic macular edema (DME).
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Debate over Orange Book device listings heard on multiple fronts

May 1, 2024
By Mari Serebrov
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
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Cardinal Health Monoject Disposable Syringes

US FDA drops warning on Cardinal Health over third party devices

May 1, 2024
By Mark McCarty
The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
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Medtronic's Inceptiv neurostimulator

Medtronic wins FDA approval for pain-sensing spinal cord stimulator

May 1, 2024
By Holland Johnson
Medtronic plc said it secured U.S. FDA approval for its first closed-loop spinal cord stimulator (SCS), designed to take in signals from the body and adjust its therapy automatically.
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Illustration of brain with electrical activity background

Epitel snags FDA clearance for two epilepsy devices

May 1, 2024
By Annette Boyle
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
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U.S. FDA headquarters

FDA wary of impact of retirements on inspectional activities

May 1, 2024
By Mark McCarty
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome.
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Dollar signs in blister packs

Two more challenges to US Rx price negotiations dismissed

April 30, 2024
By Mari Serebrov
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
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​Zogenix acquisition at heart of SEC insider trading settlement​

April 30, 2024
Three people have agreed to pay more than $170,000 to settle U.S. SEC insider trading charges related to UCB SA’s $1.9 billion acquisition of Zogenix Inc.
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