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FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency

The Pharma Data

FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency Novo Nordisk announced today that the U.S. years and older who have growth failure due to inadequate secretion of endogenous growth hormone. cm/year vs. 11.7 cm/year, respectively). cm/year vs. 11.7 cm/year, respectively).

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$2.3m Gates Foundation grant to accelerate global drug discovery 

Drug Discovery World

One example is that the model can circumvent the difficulties in demonstrating in vivo drug efficacy which arise because of mouse specific metabolism issues. Edinburgh-based PhaSER Biomedical (PhaSER) has received a Bill & Melinda Gates Foundation grant totalling $2.3m A key stage of compound progression. The post $2.3m

Drugs 52
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The latest advances in breast cancer therapy

Drug Discovery World

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months in heavily pre-treated patients.

HR 52
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The regulatory round-up: Eight key FDA decisions

Drug Discovery World

The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. Here’s a summary. Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February.

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Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

The Pharma Data

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52
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Gene Switch: A Novel Platform for Switching Genes On and Off

Roots Analysis

Overview of Gene Switch The notion that genes might be turned on and off was discovered several decades ago when studies revealed that E. coli bacteria, as well as lambda bacteriophage, can adapt to the alterations in the composition of their nutrient medium. These genetic switches assist transcription factors in binding to the promoter region.

Gene 40
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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Until recently, drug carcinogenicity assessment required two different in vivo studies, one of which was typically a two-year lifetime study in rats. Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. billion and take over 10 years.