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BioWorld - Friday, July 4, 2025
Home » Topics » Regulatory

Regulatory
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China in red on globe

Royal Philips hit with FDA warning over facility in China

April 23, 2024
By Mark McCarty
Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines.
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3D map of China

China’s NMPA may expect domestic HFE work for imported devices

April 23, 2024
By Mark McCarty
China’s National Medical Products Administration (NMPA) has issued a guidance for human factors engineering (HFE) of medical devices, a document that by some accounts aligns fairly well with guidance from the U.S. FDA. However, Yvonne Limpens, manager of the human factors program at Emergo by UL, said NMPA may push for domestic HFE testing on imported devices because of a perception that device usability may be different in China than in other nations, thus adding to the cost of doing business in the world’s second most populous nation.
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Artistic rendering of deep brain stimulation.

Neurovalens gets FDA nod for neurostimulator to treat anxiety

April 23, 2024
By Shani Alexander
Neurovalens Ltd recently received U.S. FDA clearance for its Modius Stress device, a neurostimulator that treats people suffering from generalized anxiety disorder (GAD). It also closed a £2.1 million (US$2.65 million) funding round and is planning to raise up to $50 million in a series B fundraising round to be launched later this year.
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Anktiva

Immunitybio’s bladder cancer therapy, Anktiva, gets FDA approval

April 23, 2024
By Lee Landenberger
After several delays, the interleukin-15 superagonist Anktiva (nogapendekin alfa inbakicept) from Immunitybio Inc. has been approved by the U.S. FDA for treating bladder cancer, specifically Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
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Cancer tumor in breast illustration

Lumicell shines a light on residual breast cancer with FDA approvals

April 22, 2024
By Annette Boyle
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system.  
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Colorectal cancer illustration

Genfleet’s KRAS G12C inhibitor moving into phase III

April 22, 2024
By Tamra Sami
Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance. GFH-925 was the first KRAS G12C inhibitor to receive breakthrough therapy designation from China's National Medical Products Administration for previously treated advanced CRC.
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Photo of woman sleeping on laptop surrounded by coffee mugs
Neurology/Psychiatric

Centessa cleared to commence clinical trials of ORX-750 in US

April 22, 2024
The U.S. FDA has cleared Centessa Pharmaceuticals plc’s IND to initiate a phase I first-in-human, clinical trial of ORX-750 for the treatment of narcolepsy.
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Revised 340B dispute resolution process ‘panders’ to hospitals

April 19, 2024
By Karen Carey
The Pharmaceutical Research and Manufacturers of America (PhRMA) is not happy with the Biden administration or the new 340B rule, finalized on April 18 by the U.S. Department of Health and Human Services (HHS), concerning the dispute resolution process put in place in 2020.
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FDA approved metal stamp
Biopharma regulatory actions and approvals March 2024

US FDA makes history with 30 drugs approved in March

April 19, 2024
By Amanda Lanier
In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals. In 2023, the FDA greenlit an average of about 16 drugs per month, 12.5 in 2022, and 17 in both 2021 and 2020. The surge in March marks a 173% increase from the 11 drugs approved in February.
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Gears with regulatory words
MDMA Annual Meeting

UK considering mutual recognition for FDA device reviews

April 19, 2024
By Mark McCarty
Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.
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