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Liver injuries prompt clinical hold on Sanofi BTK drug

pharmaphorum

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. All the BTK inhibitors are designed to be able to cross the blood brain barrier and enter the central nervous system, dampening down the autoimmune response that leads to neuronal damage in MS.

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Three Sales Compensation Pitfalls to Avoid for a Rare Disease Product Launch

The Marketing Advantage

Lack of Data and/or Proxies There is typically little to no competitive data available With over 95% of the over 7,000 estimated rare diseases having no treatment, these products typically have no competition and thus no competitive data. Additionally, though claims data, ICD-11 codes, patient advocacy groups, etc.

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Drug repurposing, real world data and AI/ML: perspectives and opportunities

Clarivate

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).

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Pharma Fix: The quest for the next tuberculosis vaccine

Pharmaceutical Technology

Fox says adjuvant protein subunit vaccines can be a safer approach compared to live attenuated virus vaccines as there is a minimized risk of developing side effects. GC Biopharma is also running a Phase III trial for its live-attenuated vaccine GC-3107A to replace BCG.

Pharma 64