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Home » Topics » Regulatory

Regulatory
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China increases antimonopoly law enforcement in the biopharmaceutical industry

June 5, 2023
By Zhang Mengying
Antimonopoly regulators in China are rebooting efforts to keep industries in check and may be zeroing in on the biopharma space.
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Regulatory actions for June 5, 2023

June 5, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Regent, Avadel, Bioinvent, Canbridge, Daiichi Sankyo, Foghorn, Hemogenyx, Innovent, Kyverna, Springworks, Theratechnologies.
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Regulatory actions for June 2, 2023

June 2, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armis.
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Sea-Long Medical says FDA inspection ‘a good learning experience’

June 2, 2023
By Mark McCarty
U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.
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digital health

China ramps up efforts to digitize health

June 2, 2023
By Alfred Romann
China continues to ramp up efforts to digitize its health care system, as it moves closer toward a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow significantly over the next decade.
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Philips-Intellivue-6-2.jpg

Philips and Masimo receive FDA clearance for advanced monitoring

June 2, 2023
By Annette Boyle
Royal Philips NV and Masimo Corp. received U.S. FDA clearance that allows the activation of Sedline brain function monitoring, regional oximetry and carbon dioxide measurements in Philips Intellivue MX750 and MX850 patient monitors, which will streamline decision-making for clinicians by eliminating the need for separate pieces of monitoring equipment. The integrated equipment can help clinicians more quickly assess and monitor cerebral oxygenation, anesthetic sedation and patient respiratory performance using the same monitor.
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Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 2, 2023
By Tamra Sami
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
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Regulatory actions for June 2, 2023

June 2, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Astrazeneca, Amarin, Coherus, Edding, Enterin, Merck, Minoryx, Molecular Templates, Pfizer, TG, YS.
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Regulatory actions for June 1, 2023

June 1, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardiorenal, Ezra, Royal Philips, Seegene.
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Orlucent handheld molecular-based imager

Orlucent receives breakthrough device designation for hand-held mole imaging system

June 1, 2023
By David Godkin
If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.
Read More
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