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Intellia, Regeneron ace first trial with ‘in vivo’ CRISPR drug

pharmaphorum

So far, human trial data for gene-editing drugs have been generated for ex vivo therapies, meaning the CRISPR technology is used to modify cells outside the body, which are then reinfused into the patient. — Eric Topol (@EricTopol) June 26, 2021. — Eric Topol (@EricTopol) June 26, 2021.

In-Vivo 105
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Merck and Orna partner for RNA technology-based vaccines and therapies

Pharmaceutical Technology

oRNA molecules have been demonstrated to possess increased stability in vivo compared to linear mRNA and can potentially create more quantities of therapeutic proteins within the body. . These molecules synthesised newly are packaged densely into custom lipid nanoparticles (LNPs), which Orna has made to act on the body’s crucial tissues.

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Medicines Discovery Catapult relaunches Wolfson Radiochemistry facility in Manchester

pharmaphorum

The combination of MDC’s in vivo imaging and infrastructure, with WMIC’s heritage in radiochemistry, further strengthens the national PET Network, which has been established across the UK by MDC and leading academic centres of excellence. ” Find out more about MDCs PET Imaging expertise here.

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COVID-19: Celltrion’s therapeutic option

pharmaphorum

In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19. pharmaphorum spoke to Kwon Ki-sung, Head of Celltrion’s R&D unit, to learn more. Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19.

Antibody 105
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A PSA on PSGs: PSG Meetings Are Now Available

FDA Law Blog

A PSG teleconference is a forum for applicants to obtain feedback on the impact of a new or revised PSG on an in-progress development program for which in vivo bioequivalence studies have either commenced or completed. Meeting package content, timing of submission, and directions for submission are also covered by this Guidance.

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THE RISING REALM: BIOPRESERVATION MEDIA INDUSTRY

Roots Analysis

Biopreservation is the exclusive biological approach designated for the preservation of cells, tissues and organs ex-vivo for the purpose of storage, shipment and transportation. Biopreservation media is one of the most crucial entity in conferring effectiveness. F) to 8°C (46.4°F).

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Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.