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US FDA clears Transcenta’s IND for Rett syndrome treatment

Pharmaceutical Technology

The multi-centre, open-label, single-arm clinical trial has been designed to evaluate the efficacy, tolerability, and safety of a single dose of NGN-401 delivered using a one-time ICV procedure. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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China NMPA accepts Juventas’ NDA for leukaemia treatment

Pharmaceutical Technology

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy.

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5 Qualities to Look for in Your Veterinary Pharmacy Partners

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Accurate Ingredient Labeling Accurate labeling also applies more in 503A pharmacies than 503B outsourcing facilities due to stricter regulations on 503B manufacturers. 503A pharmacies have less testing, or sometimes no testing, to verify their label claims. Our blog gives you a comprehensive look at the two. Read the Blog 3.

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CSL receives EC CMA approval for haemophilia B gene therapy

Pharmaceutical Technology

Its decision is based on the data obtained from the ongoing, open-label, multinational, single-arm, pivotal Phase III HOPE-B trial. The regulatory approval followed a positive opinion from Committee for Medicinal Products for Human Use (CHMP) in December last year. The trial is designed to evaluate the safety and efficacy of Hemgenix.

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Capricor and Nippon Shinyaku partner for DMD therapy distribution in Japan

Pharmaceutical Technology

The data from our recently announced 18-month HOPE-2 open-label extension study showed evidence of disease modification and showed statistically significant differences in the Performance of the Upper Limb (PUL).” “CAP-1002 has shown clinical benefits for cardiac and skeletal muscle myopathy, which few therapies have demonstrated.

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Paw-sitively Efficient Inventory Management for Veterinary Professionals

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Download: Seasonal Prep Checklist for Veterinary Practices (It makes a great print-out for your practice!) Download our inventory management guide for 7 best practices that increase ROI. Clearly label shelves and containers to minimize confusion. Haven’t made the switch to digital tools in your practice?

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Email Marketing Campaigns for Pharma: Boost Engagement & Compliance

Pharma Marketing Network

Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Drug names and indications must align with FDA-approved labeling. signing up for a webinar, downloading a whitepaper)? Click-Through Rate (CTR) : Are recipients engaging with links?

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