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Hourglass on glowing circuit board, symbolizing time and technology

MHRA chooses five technologies for AI Airlock pilot

Dec. 4, 2024
By Shani Alexander
The U.K.'s Medicines and Health Care Products Regulatory Agency chose five technologies for its AI Airlock pilot program as it looks to understand the best way to regulate artificial intelligence-powered medical devices so that they can be safely deployed across the national health service.
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U.S. FDA headquarters

FDA finalizes predetermined change control plans

Dec. 4, 2024
By Annette Boyle
At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,” aims to support the iterative improvement central to many algorithms while minimizing potential issues with safety and efficacy.
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Endocrine/metabolic

Arrowhead seeks clearance to begin clinical trials with ARO-ALK7 for obesity

Dec. 4, 2024
Arrowhead Pharmaceuticals Inc. has filed a request to the New Zealand Medicines and Medical Devices Safety Authority.
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US lawmakers call out PBM role in opioid epidemic

Dec. 3, 2024
By Mari Serebrov
The congressional finger-pointing at pharmacy benefit managers (PBMs) continues. The latest singling out is in a bipartisan letter from four House members calling on the U.S. Department of Justice to investigate and hold PBMs accountable for the role they played in the nationwide opioid crisis.
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Kiromic’s nondisclosure of clinical hold leads to SEC settlements

Dec. 3, 2024
By Mari Serebrov
Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million the company desperately needed.
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Woman  in military clothing talking with psychologist

Wave cheers MERT’s FDA breakthrough device designation for PTSD

Dec. 3, 2024
By Annette Boyle
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
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Map of Europe, Medical Device Regulation (MDR) text

Neo Medical gets MDR approval for spine care platform

Dec. 3, 2024
By Shani Alexander
Neo Medical SA received certification under the EU Medical Device Regulation for its entire portfolio of spine surgical technologies. The approval means that the company can continue selling its products, which helps with the surgical treatment of back pain, across markets in Europe as they are in compliance with the high-quality control standards required for medical devices.
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Antibodies attacking cancer cell
Immuno-oncology

Oncoc4 gains US IND approval for bispecific antibody for advanced solid tumors

Dec. 3, 2024
Oncoc4 Inc. has obtained IND approval from the FDA for AI-081, a PD-1 and VEGF bispecific antibody for the treatment of advanced solid tumors.
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Respiratory

FDA awards orphan drug designation to Alveogene’s gene therapy for SP-B deficiency

Dec. 3, 2024
Alveogene Ltd. has announced its novel inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency, AVG-002, has been awarded orphan drug designation by the FDA.
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Rendering of iNKT cell

Arovella heads toward clinic with CAR-19-iNKT cells

Dec. 3, 2024
By Tamra Sami
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Read More
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