Category: Neurology
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FDA Adcom to Weigh Conflicting Data on Rexulti-Zoloft combo for PTSD
FDA’s upcoming advisory panel will assess whether one positive and one negative Phase III trial, plus exploratory data, support approval.
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Illimis Therapeutics secures $42 million to boost CNS and immune drug pipeline
The South Korean biotech has previously partnered with Eli Lilly to advance the development of neurodegenerative drug platform.
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FDA clears Insightec’s bilateral focused ultrasound for Parkinson’s
The US agency’s approval expands Exablate Neuro’s use to include patients with advanced Parkinson’s disease (PD).
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From Blade Runner to battlefield: US military and BTF plan to assess TBI in seconds
The BTF and MTBI2 are co-developing rapid screening guidelines that could assess traumatic brain injury (TBI) in 90 seconds.
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Auxilium trials nerve regeneration NeuroSpan Bridge device
The NeuroSpan Bridge device is designed to potentially restore nerve function and reduce complications in patients with nerve injuries.
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AD/PD2025: Roche plans Phase III trial for Alzheimer’s monoclonal therapy
Armed with positive results from a Phase II study, the company plans to start a Phase III trial evaluating trontinemab in Alzheimer’s.
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Teva boasts high patient satisfaction with subcutaneous schizophrenia drug
Over 92% of patients taking the TEV-‘749 in the Phase III SOLARIS trial survey were satisfied or very satisfied with the drug’s scheduling and administration.
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Emalex eyes FDA approval after Tourette syndrome drug’s Phase III win
The Phase III trial evaluating the company’s dopamine-1 receptor antagonist met primary endpoints in patients with Tourette syndrome.
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DeFloria plans Phase II trial for cannabinoid autism spectrum disorder drug
DeFloria has received clearance from the US FDA to plan a Phase II trial, which is expected to start by mid-year 2025.
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FDA greenlights Vertex’s non-opioid pain killer, Journavx
Vertex has set the wholesale price of the “non-addictive”, non-opioid pain killer at $15.50 per 50mg pill in the US.
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J&J scores FDA approval for standalone use of Spravato in depression
The US regulatory agency has expanded Spravato’s label to allow it to be used as a monotherapy in patients with major depressive disorder (MDD).
Latest posts
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Navigating the Risks and Rewards of Biomarker-Based Surrogates and Accelerated Approval
The risks and rewards of biomarker-based surrogates are crucial for optimizing clinical trial outcomes and guiding effective treatments.
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ASH25: Gallop’s LYT-200 shows unprecedented survival in AML
The company’s execs talk about the striking efficacy and safety signals seen in Phase I data, the science behind the molecule, and their vision for transforming AML therapy.
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Promis reports first human evidence of aβ oligomer reduction by pmn310
PMN310 demonstrates dose-dependent reduction of amyloid-beta oligomers in human CSF, marking a key milestone in Alzheimer’s treatment development.
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Urologic Health secures $11 million for non-invasive bladder monitoring
Urologic Health raises $11million seed funding to advance a catheter-free bladder monitoring platform toward FDA clearance and US market entry.
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Novo Nordisk’s denecimig cuts bleeding in hemophilia A regardless of inhibitors
Phase III trial shows once‑monthly and once‑weekly denecimig (Mim8) significantly reduces annualized bleeding rate versus standard care, with up to 95% of patients bleed‑free.