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The latest drug discovery product launches

Drug Discovery World

The platform works with the SYNTAX Hi-Fidelity reagent kits for synthesising longer oligos. It is accessible, boosts developer productivity and aims to save up to 80% of the time and cost associated with traditional API management strategies.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

A 2020 PhRMA report on the cell and gene therapy pipeline found 362 therapies in a range of stages in clinical development by biopharmaceutical companies in the United States. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA. Identify critical development issues or deficiencies to address.

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Regulatory Trends in Cell and Gene Therapies

Advarra

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline.

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Expert view: What’s next for cell and gene therapy?

Drug Discovery World

According to Foster, the industry needs to work together to address the problems from the earliest phases of pre-clinical development. Clinical endpoints are no longer the only things that matter. Lending to the time-to-clinic discrepancy, we also see increasing demands on manufacturing capacity for CGT reagents.”

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BioSpace Global Roundup: Ipsen Wins Fast Track Designation for Cancer Drug and More

The Pharma Data

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. to establish a new joint venture company, Nanjing AuroRNA Biotech Co.,

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Fortis Life Sciences leads the way in custom antibody discovery

Drug Discovery World

Moreover, custom antibodies are a key reagent in companion diagnostics for these novel therapeutics. Custom antibodies can be developed for pharmacokinetic assays and biodistribution assays, supporting therapeutic development by giving researchers data about the behaviour of their novel therapeutic in vivo.