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FDA grants approval for bluebird’s Zynteglo to treat beta-thalassemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia 0 genotypes. thalassemia in adult and paediatric patients.

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Can genetic data be a magic bullet for drug R&D?

pharmaphorum

Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. The logical extension to this kind of approach is treating individual patients, with their individual genetic makeup.

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FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

The Pharma Data

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination).

Genome 52
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How Pharmacogenomics may finally realise its promise

pharmaphorum

The participants undergo monitoring for genetic variations that could potentially negatively impact their reaction to therapies. The program is aiming to genotype roughly 150,000 participants over the next few years to demonstrate the impact personalised testing can have on a large scale. About the Author.

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Adial Pharmaceuticals Provides Update on its ONWARD(TM) Pivotal Phase 3 Trial of AD04 for Treatment of Alcohol Use Disorder

The Pharma Data

ONWARD is investigating Adial’s lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes. The European market is expected to be similar in size. ” About Adial Pharmaceuticals, Inc.

Trials 52
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Innovative Companies Diving into The Neuro Market Ahead of 2021

The Pharma Data

Vigil’s pipeline strategy is to target these diseases by combining a high-level understanding of microglia physiology, disease genotyping, and patient phenotyping to identify specific genetic variations associated with microglial dysfunction.

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LabCorp Backs Resolution Bioscience’s Liquid Biopsy Test for NSCLC

XTalks

Based on the genetic biomarker(s) identified, the most effective therapy targeting the specific molecular marker can be selected. The liquid biopsy will therefore help personalize medicines for patients based on the molecular features of their disease.

Gene 105