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Regulatory
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European Union flag with wooden gavel

New notified body survey highlights role of poor-quality submissions

Nov. 13, 2024
By Mark McCarty
The European Commission posted the results of the latest survey of notified bodies, and as the saying goes, there’s good news and bad news.
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Woman about to receive a vaccine
Immune

CSPC’s HPV mRNA vaccine candidate cleared to enter clinic in China

Nov. 13, 2024
CSPC Pharmaceutical Group Ltd.’s SYS-6026 has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials for the treatment of high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV) type 16 or 18.
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3D illustration showing presence of tumor inside prostate gland
Diagnostics

Antelope Surgical’s AS-1986NS cleared to enter clinic

Nov. 13, 2024
Antelope Surgical Solutions Inc. has received commercial IND approval from the FDA for its novel prostate cancer technology, AS-1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, will be evaluated in trials with the aim of addressing prostate cancer identification and surgical margin delineation.
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FDA lifts clinical hold on Carsgen’s CAR Ts following warnings

Nov. 12, 2024
By Tamra Sami
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
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Laptop displaying FDA logo

​Owens & Minor draws FDA warning for lack of sterilization documentation

Nov. 12, 2024
By Mark McCarty
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
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Momentis Surgical Anovo robotic platform

Momentis gains FDA clearance for second generation surgical robot

Nov. 12, 2024
By Shani Alexander
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
Read More
AI biotech research concept with lightbulb and digital background

Tempus Labs wins reversal of patent rejection over machine learning

Nov. 12, 2024
By Mark McCarty
Abstract ideas are not generally eligible for patents in the U.S., but a recent dispute heard by the U.S. Patent Trial and Appeal Board adds a new twist to the question.
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Transmission electron microscope image of H5N1 virus particles
Immune

Arcturus gains IND clearance for H5N1 influenza sa-RNA vaccine candidate

Nov. 12, 2024
Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
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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.
Read More
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