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BioWorld - Tuesday, June 6, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory actions for June 2, 2023

June 2, 2023
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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
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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
No Comments
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.
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Debt limit illustration

US debt ceiling deal would flat-line NIH, FDA appropriations in fiscal 2024

June 1, 2023
By Mark McCarty
No Comments
The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the National Institutes of Health or the FDA, two programs of intense interest for companies in the life sciences.
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Architectural pillars

SCOTUS: Belief, not interpretation, at heart of FCA violations

June 1, 2023
By Mari Serebrov
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With False Claims Act (FCA) whistle-blower lawsuits multiplying amid the complexity of regulations that often are unclear, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down June 1. But it’s not what the biopharma and med-tech industries were hoping for.
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Regulatory actions for June 1, 2023

June 1, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket.
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Elderly person receiving shot

US FDA approves Abrysvo, the second RSV vaccine for seniors

June 1, 2023
By Karen Carey
No Comments
Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.
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Regulatory actions for May 31, 2023

May 31, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Think Surgical.
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Prostate cancer cells

NICE sees evidence gaps for MRI-ultrasound fusion prostate biopsy systems

May 31, 2023
By Mark McCarty
No Comments
In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
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Omni Legend - GE Healthcare

GE Healthcare wins FDA OK for Precision DL PET/CT image processing software

May 31, 2023
By Meg Bryant
No Comments
The U.S. FDA has granted 510(k) clearance to GE Healthcare Technologies Inc. for its Precision DL for PET/CT, an artificial intelligence (AI) and deep learning (DL)-powered software designed to sharpen quality and improve efficiencies in medical imaging. Part of the company’s Effortless Recon DL portfolio, the technology is available on GE’s Omni Legend PET/CT digital scanner.
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