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BioWorld - Sunday, January 18, 2026
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Gears with regulatory words

Trio of regulators issues guidelines for transparency for AI

June 17, 2024
By Mark McCarty
For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.
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US flag with microscope

US FDA’s Califf hints at more routine use of SGEs at advisories

June 17, 2024
By Mark McCarty
Criticisms over the U.S. FDA’s use of advisory committees led the agency to hold a June 13 public hearing during which FDA commissioner Bob Califf said the agency is working to improve the experience of special government employees who take part in these hearings.
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Appointments and advancements for June 17, 2024

June 17, 2024
New hires and promotions in the med-tech industry, including: Medical Technology Enterprise Consortium.
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Financings for June 17, 2024

June 17, 2024
Med-tech firms raising money in public or private financings, including: Berlin Heals.
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In the clinic for June 17, 2024

June 17, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Delve Bio, Glucomodicum, Natera.
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Other news to note for June 17, 2024

June 17, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bicycle Health, Bluejay Diagnostics, Co-Diagnostics, Glaukos, K2 Medical, LED Radiofluidics, MGI, Neuromod, Opiaid, Premium Imaging, Seqone, Shangkang Life Science, Shineco, Turing Video, Vapotherm.
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Regulatory actions for June 17, 2024

June 17, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardioflow, Elutia, Philips, Siemens.
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British and U.S. flags

UK, US authorities sign MOU for standard essential patents

June 14, 2024
By Mark McCarty
Even patent attorneys aren’t particularly collectively excited about standard essential patents, but that hasn’t stopped the U.S. Patent and Trademark Office from signing a memorandum of understanding with the U.K. Intellectual Property Office to collaborate on policies related to these patents.
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Elderly woman holding illustration of brain with missing puzzle piece

Regulatory flexibility shown in cancer space needed in Alzheimer’s

June 14, 2024
By Mari Serebrov
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
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No Nasdaq for now: Radiopharma firm Telix pulls US IPO

June 14, 2024

A week after generating buzz with its proposed Nasdaq listing and plans to raise about $200 million, Telix Pharmaceuticals Ltd. withdrew its U.S. IPO filing, citing market conditions. The Australian radiopharma firm’s shares continue trading on the Australian Securities Exchange (TLX), where they closed June 14 at AU$16.61 (US$10.98), up AU15 cents.


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