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Conversations from ESMO Targeted Anticancer Therapies Congress 2024 

Drug Discovery World

In vivo, METTL1 inhibitors induce tumour growth inhibition in both immune-deficient and immune-competent mouse strains. In addition to STC-15 and our METTL1, our pipeline contains a number of preclinical programs that are advancing rapidly for the treatment of viruses, neurodegeneration, cancer, and immuno-inflammatory conditions.

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In the News: October Regulatory and Development Updates

Camargo

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program.

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The regulatory round-up: Eight key FDA decisions

Drug Discovery World

The approval is for endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. Here’s a summary.

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Federal Court finds a combination therapy patent valid and infringed

Pharma in Brief

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). OPSUMIT® is a tablet containing macitentan. Background. Janssen Inc. Janssen Inc. Sandoz Canada Inc. Sandoz ) sought approval for a generic macitentan product.

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10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

Rare diseases can often be progressive, chronic and fatal. Approximately 72 percent of rare diseases are genetic, and around 70 percent of rare genetic diseases emerge in childhood. Sadly, one-third of children with rare diseases die before their first birthday.

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Overcoming diverging regulatory expectations to bring CGTs to market

Drug Discovery World

For example, the FDA’s Center for Biologics Evaluation and Research (CBER) 3 , which regulates biological products for human use, differentiates between in vivo gene therapy (new genes are inserted into the body to target cells) and ex vivo gene therapy (cells are modified outside the body and then administered back into the patient).

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Top five breakthroughs in advancing breast cancer therapies

Drug Discovery World

Not only is October Breast Cancer Awareness Month but October 21 is Wear it Pink 2022, Breast Cancer Now’s annual fundraising day. The last month has seen a number of leaps in our understanding of difficult to treat and treatment resistant breast cancers, so here are Drug Discovery World’s top 5 research breakthroughs.

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