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Navigating Neuroscience Trials: Biomarkers, Imaging and CRO Strategies

XTalks

The world of neuroscience trials is rapidly evolving, presenting new challenges and opportunities for researchers and clinicians. The worldwide market for neurology clinical trials stood at a valuation of $5.24 There is currently a heightened emphasis on imaging and liquid biomarkers in neuroscience clinical trials.

Trials 111
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Osimertinib Resistance and EGFR Mutations in NSCLC Treatment

Bioengineer

This mutation hinders the drug’s binding to the mutant EGFR protein. Osimertinib, however, can covalently bind to the T790M and cysteine-797 (C797) residue at the protein’s ATP binding site, overcoming resistance mechanisms. Real-world cohorts report a prevalence of C797 mutations between 11% and 29%.

Genome 119
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Congenital fibrinogen deficiency market forecast to reach $800m across 3MM by 2031

Pharmaceutical Technology

BT-524 is currently being studied in a Phase III trial (ADFIRST) in AFD patients undergoing elective spinal and/or abdominal surgery and has high potential to gain approval for both indications. This provides a large advantage over currently marketed products and may allow BT-524 to capture a significant share of the market at launch.

Marketing 130
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Evolution in Hepatitis B and C Virus: Can we expect success similar to Hepatitis C in Hepatitis B as well?

Delveinsight

The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). Interferons are naturally occurring proteins in the body; recombinant IFNa is the protein-based drug that works to mobilize the body’s natural immune system to fight disease. in January 2019.

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Type 1 Diabetes Vaccine: Does Diamyd Have a Winning Formula?

XTalks

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals. The DIAGNODE-2 Trial.

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FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance

The Pharma Data

Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

Drugs 52
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Treatment of Metastatic Triple-Negative Breast Cancer

The Pharma Data

SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.