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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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Taysha Gene Therapies Receives Rare Pediatric Disease and Orphan Drug Designations for TSHA-105 for the Treatment of Epilepsy Caused by SLC13A5 Deficiency

The Pharma Data

“There are no approved therapies for epilepsy caused by SLC13A5 that address the underlying cause of this disease,” said RA Session II, President, Founder and CEO of Taysha. “We Taysha’s commitment to developing a potentially life-changing gene therapy for SLC13A5 deficiency is greatly welcomed by our patient community.”.

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Scaling up: The need for human cells to give better access to cell therapies

Drug Discovery World

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

Therapies 130
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Preparing for new-era drug modalities with technology 

Drug Discovery World

Samsung Biologics’ Senior Vice President, James Park, explores the opportunities emerging for CDMOs to support mRNA developers as they explore new therapeutic areas for patients. . One aspect that makes mRNA technology popular with drug developers is that its proteins can be easily edited. Why mRNA has potential .

Vaccine 130
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Fibrosis research: Advances and challenges 

Drug Discovery World

Phase I of the clinical program will dose healthy volunteers with single ascending doses of FIB992 before proceeding to a multiple ascending dose study where the drug is administered for a two-week period. Patients experience severe side effects with current medications leading them to discontinue therapy.

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Synthetic biology: Shaping the future of drug discovery 

Drug Discovery World

billion by 2026, at a compound annual growth rate (CAGR) of 28.4% during the forecast period of 2021-2026. Just taking a small snapshot of the current sector shines a light on the depth of development taking place. BCC Research reports that the global market for synthetic biology is estimated to increase from $9.5

DNA 130
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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40