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BioWorld - Friday, September 22, 2023
Home » Topics » Regulatory

Regulatory
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Neuroderm pump

Patent update: Neuroderm improves the design for its wearable anti-Parkinson’s infusion pump

Sep. 20, 2023
By Simon Kerton
No Comments
The latest patent application from Neuroderm Ltd. described a magnetic coupling and detection mechanism for its small two-part wearable infusion drug delivery device that delivers a liquid drug to Parkinson’s disease patients subcutaneously.
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Cytomegalovirus in a human cell
Infection

Spybiotech seeks clearance in UK to begin clinical testing of SPYVLP-01 for human CMV

Sep. 20, 2023
No Comments
Spybiotech Ltd. has filed a clinical trial application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate SPYVLP-01, a vaccine targeting human cytomegalovirus (CMV) using its hepatitis B virus-like-particle platform technology.
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Magnifying glass, FDA concept image

FDA converts conformity assessment pilot into a full-fledged program

Sep. 20, 2023
By Mark McCarty
No Comments
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is one of a number of efforts on the agency’s part to reduce the drag on premarket medical device submissions, but the agency has now converted the ASCA pilot into a full-blown regulatory program. Fortunately for both the FDA and industry, most of the guidance groundwork is already in place, making the ASCA program a ready-to-go method for streamlining at least one element of premarket applications for medical devices.
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Medici drug delivery system

Adcom a make-it-or-break-it hearing for combo diabetes product

Sep. 19, 2023
By Mari Serebrov
No Comments
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
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FDA eyes overhaul of IT system with an emphasis on agency-wide integration

Sep. 19, 2023
By Mark McCarty
No Comments
Developers of combination products face an unusual dilemma in their interactions with the U.S. FDA, given that the data for the constituent products reside in multiple product centers. Some of the related clunkiness may soon be a thing of the past thanks to a new four-year proposal to overhaul the FDA’s information technology infrastructure, which among other things will emphasize a more seamless sharing of data across centers, precisely the kind of initiative that would facilitate reviews of combination products.
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Regulatory actions for Sept. 19, 2023

Sep. 19, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airamed, Inbrain Neuroelectronics, Natural Cycles, Spectrawave, T2 Biosystems, Tasso.
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Regulatory actions for Sept. 19, 2023

Sep. 19, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Contrafect, Daiichi Sankyo, Eirgenix, Galera, GSK, Kymera, Lantern,  Lapix, Orchard, Osmol, Redhill, Sandoz.
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Mantle cell lymphoma
Cancer

Lantern’s LP-284 cleared by FDA to enter clinic for NHL

Sep. 19, 2023
No Comments
Lantern Pharma Inc. has received FDA clearance of its IND application for LP-284, being developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, double hit lymphoma and other high-grade B-cell lymphomas. Enrollment in a first-in-human phase I trial is expected to begin during the fourth quarter of this year. 
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Gastrointestinal

Therapyx’s Fapxil awarded US orphan drug designation for familial adenomatous polyposis

Sep. 19, 2023
No Comments
Therapyx Inc.’s Fapxil has been awarded orphan drug designation by the FDA for the treatment of familial adenomatous polyposis (FAP).
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Concept art for adeno-associated viral-based gene therapy.
Neurology/Psychiatric

Atamyo files CTA in Europe for ATA-200 gene therapy for limb-girdle muscular dystrophy type 2C/R5

Sep. 19, 2023
No Comments
Atamyo Therapeutics SAS has filed a clinical trial application (CTA) in Europe for ATA-200, its gene therapy targeting γ-sarcoglycan (SGCG)-related limb-girdle muscular dystrophy type 2C/R5 (LGMD-R5).
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