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The future of CNS drug development: signs of real progress

Drug Target Review

The global market for CNS therapeutics was worth an estimated $144.3 This absence of objective measures contributes to the variability in patient response to treatments, complicating efforts to produce standardised therapies. Moreover, regulatory pathways also change considerably based on the type of therapy – and guidance is sparse.

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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.

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How GPCR agonists, including antibodies, are shaping the future of metabolic care

Drug Target Review

Confo Therapeutics , led by CEO Dr Cedric Ververken, is at the forefront of developing innovative GPCR-targeted therapies using its proprietary ConfoBody ® platform. VHH-based therapies have been clinically-validated many times with multiple products in numerous indications, including for long-term dosing.

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UCB’s GEMZ Phase 3 Trial Shows Promising Results for Fenfluramine in Treating CDKL5 Deficiency Disorder

The Pharma Data

The GEMZ study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center clinical trial designed to assess the safety, efficacy, and pharmacokinetics of fenfluramine in children and adults aged 1 to 35 years diagnosed with CDD who experience uncontrolled seizures.

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Pain relief without the risk: why SRP-001 could change everything

Drug Target Review

Still, Bazan says “Vertex’s work has been so important for the pain field – to get eyes on the large market size that matches the significant societal and clinical need for pain innovation.” Bazan sees it as part of a broader shift towards combination therapies – an approach that will likely define the next generation of pain management.

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FDA Approves Tablet Form of BeOne’s BRUKINSA® for All Indications

The Pharma Data

This decision represents a pivotal moment in the evolution of treatment convenience for patients with certain B-cell malignancies, while reinforcing BRUKINSA’s stronghold in the BTK inhibitor market. Notably, BRUKINSA has emerged as the market leader in new CLL patient starts across all lines of therapy in the U.S.

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BeOne Medicines Gains CHMP Backing for BRUKINSA Tablet Formulation

The Pharma Data

BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval BeOne Medicines Ltd. This dual regulatory progress signals strong global confidence in the new formulation and sets the stage for expanded availability in key markets.