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Home » Topics » Regulatory

Regulatory
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Rapt scales back after zelnecirnon clinical hold

Nov. 11, 2024
By Lee Landenberger
Rapt Therapeutics Inc. has decided to shut down its zelnecirnon (RPT-193) program in asthma and atopic dermatitis, causing the company’s stock (NASDAQ:RAPT) to sharply decline Nov. 11.
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CAR T-cell therapy in acute lymphoblastic leukemia

Autolus’ CAR T Aucatzyl wins US FDA nod for leukemia

Nov. 11, 2024
By Nuala Moran
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
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Hyperfine Research - swoop

Hyperfine gains CE mark for MRI brain imaging software

Nov. 11, 2024
By Shani Alexander
Hyperfine Inc. gained CE mark approval for the latest generation of its artificial intelligence-powered software for its Swoop portable magnetic resonance imaging system, under the European Medical Device Regulation.
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U.S. Capitol building

Pricing questions tank MCI’s bid for Veterans Affairs contract

Nov. 11, 2024
By Mark McCarty
The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed.
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Illustration of cryoblation procedure in breast

Icecure wins advisory nod for Prosense system for breast cancer

Nov. 11, 2024
By Mark McCarty
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.
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AI-generated digital horse illustration

FDA eyes generative AI in upcoming advisory committee hearing

Nov. 8, 2024
By Mark McCarty
The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
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DNA illustration
Neurology/psychiatric

Belief Biomed’s gene therapy for DMD designated orphan drug in US

Nov. 8, 2024
Belief Biomed Inc.’s gene therapy drug BBM-D101 has been awarded U.S. orphan drug and rare pediatric disease designations by the FDA for the treatment of Duchenne muscular dystrophy (DMD).
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Californians say yes to 340B accountability measure

Nov. 7, 2024
By Mari Serebrov
With the U.S. Congress sitting on its hands on reforms to the 340B drug discount program, states are stepping into the gap. While most state efforts have been aimed at forcing biopharma companies to give the federally mandated drug discounts to an increasing number of contract pharmacies, California is looking in a different direction. According to unofficial election results, a slim majority of the state’s voters said yes to Proposition 34, which would require certain providers that benefit from the drug discounts to spend at least 98% of their 340B revenues on direct patient care.
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Quanta Dialysis System

Quanta gets FDA clearance to use dialysis system at home

Nov. 7, 2024
By Shani Alexander
Quanta Dialysis Technologies Ltd. received the greenlight from the U.S. FDA for the use of its portable dialysis system at home. The clearance brings a much-needed option for patients with end-stage renal disease to receive their treatment in the comfort of their own homes and without a rigid dialysis schedule.
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Clinical data illustration

FDA webinar offers little insight into labeling aspects of PPI

Nov. 7, 2024
By Mark McCarty
The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or approved medical devices.
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