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How Berlinger’s climate-focused innovation is helping to reduce, remove and offset emissions from the pharmaceutical supply

Pharmaceutical Technology

Learn how Berlinger came about its innovation process, the five steps of sustainability-driven innovation and collaboration and how it can reduce emissions in its customers’ business cases in the white paper. Download the white paper to learn more. [1] Linda Schwär, VP Marketing, Berlinger & Co. 1] [link]. [2]

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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 downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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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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5 Qualities to Look for in Your Veterinary Pharmacy Partners

epicur

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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Africa’s growing vaccine capacity

Quality Matters

Of these countries, five have end-to-end manufacturing capacity, and three can import, label, or pack vaccines, a process known as fill and finish. For more information, see the full white paper martin_laura Thu, 02/09/2023 - 13:25 Global Health