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Enanta secures FDA fast track designation for EDP-323 to treat RSV

Pharmaceutical Technology

In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV).

In-Vitro 276
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Betta to commercialise C4 Therapeutics’ CFT8919 in greater China

Pharmaceutical Technology

CFT8919 is an orally bioavailable BiDAC degrader designed to exhibit potent and selective activity against EGFR L858R in patients with non-small cell lung cancer (NSCLC). The agreement will cover the Hong Kong special administrative region (SAR), the Macau SAR and Taiwan.

In-Vivo 130
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How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Approaches to Pharmacokinetic Analysis.

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NRG announces £16m Series A for IND for Parkinson’s and ALS

pharmaphorum

Meanwhile, NRG’s in vitro studies have shown its INDs to protect mitochondria and increase the viability of human cells, potentially able to halt or significantly slow progression of diseases such as Parkinson’s and ALS. Currently, the treatments available only provide management of symptoms of chronic neurodegenerative disorders.

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Innovative Companies Diving into The Neuro Market Ahead of 2021

The Pharma Data

Artificial intelligence holds immense promise to catalyze the development of the next generation of highly selective, orally bioavailable molecules, with reduced side effects, for the most impactful drug targets,” Feinberg said at the time of the launch. which will remain a key shareholder. SciNeuro Pharmaceuticals. in a statement. .

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Kronos Bio Announces Publication of Preclinical Study Results for Investigational CDK9 Inhibitor KB-0742 in Cell Chemical Biology

The Pharma Data

We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., Research s howed KB-0742 i nhibited a ndrogen r eceptor -d ependent a ctivity and r educed t umor g rowth in c astration -r esistant p rostate c ancer. SAN MATEO, Calif., and CAMBRIDGE, Mass.,

In-Vivo 40
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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).