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Newron says pivotal treatment-resistant schizophrenia trial is a go

pharmaphorum

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

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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. One of the main assets of Sanofi’s $3.7 The hold on dosing applies to subjects in the trials who have received the drug for less than 60 days.

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

The Marketing Advantage

May 9, 2023 Since the Orphan Drug Act was passed in 1983, the number of products being researched and approved for rare and orphan diseases has increased dramatically, offering hope and life-saving treatments for the millions of patients affected by these often under-served conditions.

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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

New Developments for TB In a recent Phase I clinical trial (NCT03722472), researchers have been able to test the first thermostable TB vaccine in patients. In this trial, patients were given a thermostable version of the vaccine or a non-thermostable vaccine in two treatment regimens.

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