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

The Pharma Data

Decision Regarding Slick-Haired Cattle is Agency’s First Enforcement Discretion Decision for an Intentional Genomic Alteration in an Animal for Food Use. The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. Today, the U.S.

Genome 52
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Can genetic data be a magic bullet for drug R&D?

pharmaphorum

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. 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.

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Osimertinib Resistance and EGFR Mutations in NSCLC Treatment

Bioengineer

not reached) in genomic analysis of post-progression samples from patients receiving second-line osimertinib. Importantly, a triple mutant scenario with EGFR L858R/T790M/C797S or EGFRexon19del/T790M/C797S genotype may occur in patients with T790-positive NSCLC receiving osimertinib in second or later lines. months, 95% CI 1.3,

Genome 119
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Cancer, genomics and personalised medicine: Modelling the future of oncology

pharmaphorum

How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run •What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development? •What are the implications from these changes for clinical trials?

Genome 52
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Why Proviral DNA Drug Resistance Testing is Useful in Guiding Treatment Decisions for HIV-1 Patients

XTalks

Sustained viral suppression is achieved through antiretroviral (ARV) therapy, which often consists of a cocktail of two or more ARV drugs that work to inhibit viral replication. HIV drug resistance has ben a problem since ARV drugs were first introduced in the late 1980s.

DNA 98
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How Pharmacogenomics may finally realise its promise

pharmaphorum

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up.

Genome 98
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Evolution in Hepatitis B and C Virus: Can we expect success similar to Hepatitis C in Hepatitis B as well?

Delveinsight

alcohol, certain drugs) and autoimmune diseases can also cause hepatitis. Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. Both drugs resulted in inhibition of HCV replication.