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The rising impact of biomarkers in early clinical development

Drug Target Review

Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms. A biomarker is a measurable indicator of a biological process, disease state, or response to a treatment.

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The future of CNS drug development: signs of real progress

Drug Target Review

Disorders such as Alzheimer’s disease , primary glioblastoma and amyotrophic lateral sclerosis (ALS) all affect the CNS and are considered fatal, while more common conditions, including depression , strokes and epilepsy , require long-term treatments. The global market for CNS therapeutics was worth an estimated $144.3

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

The Pharma Data

The trial met both its primary and key secondary endpoints, signaling a potential breakthrough in a condition with few, if any, effective treatment options. It is characterized by early-onset, treatment-resistant seizures, beginning as early as six weeks of age, and profound global neurodevelopmental impairment.

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

Drug Target Review

As the limitations of current treatments become increasingly clear, researchers are exploring new, safer approaches. His focus, however, is on addressing a critical gap in medicine: the lack of safe, non-addictive pain treatments – a challenge that has driven the development of SRP-001. “As From bench to bedside: what is next?

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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.

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Gepirone

New Drug Approvals

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 1] It is taken orally. [1] 1] [3] Gepirone is a member of the azapirone group of compounds. [2]

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