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Teva, MedinCell announce positive results for registration trial of TV-46000/mdc-IRM for patients with Schizophrenia
pharmaceutical-business-review
January 13, 2021
Teva Pharmaceuticals Industries and MedinCell announced positive results for study TV46000-CNS-30072 (the RISE study – The Risperidone Subcutaneous Extended-Release Study), a Phase 3 clinical trial designed to evaluate the efficacy of TV-46000/mdc-IRM ...
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Neurelis Completes Pre-IND Meeting with FDA for Acute Agitation Treatment
americanpharmaceuticalreview
December 09, 2020
Neurelis has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment.
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Janssen seeks EU approval for twice-yearly schizophrenia treatment
pharmatimes
December 08, 2020
Janssen has submitted a marketing authorisation extension application to the European Medicines Agency (EMA) for paliperidone palmitate six-monthly (PP6M) as a maintenance treatment for adults living with schizophrenia.
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CVN058 shows promise in Phase Ib schizophrenia cognition study
europeanpharmaceuticalreview
November 20, 2020
A single dose of CVN058 was able to normalise brainwaves being used as a biomarker for cognitive impairment associated with schizophrenia.
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FDA Advisory Committee Votes in Support of ALKS 3831 for Schizophrenia, Bipolar I
americanpharmaceuticalreview
October 16, 2020
Alkermes announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA).
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OWP Announces IND Approval for Quetiapine Fumarate Liquid Oral Suspension Formulation
americanpharmaceuticalreview
October 10, 2020
OWP has received approval for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the first-ever liquid formulation of quetiapine fumarate.
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Schizophrenia Treatment Trial Meets Primary Endpoint
americanpharmaceuticalreview
September 21, 2020
Boehringer Ingelheim announced the results from a 12-week, placebo-controlled Phase II trial, that demonstrate BI 425809 met its primary endpoint. The data showed improvement in cognition in stable adult patients with schizophrenia.
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Boehringer Ingelheim and Click Therapeutics join hands for CT-155, digital therapeutic for schizophrenia
expresspharma
September 14, 2020
Boehringer Ingelheim and Click Therapeutics announced they have entered into a collaboration for the development and commercialisation of a prescription-based digital therapeutic.
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Neurocrine Licenses Seven Takeda Compounds in $2B Deal
contractpharma
June 22, 2020
To develop and commercialize early-to-mid-stage psychiatry pipeline including assets for for schizophrenia, treatment-resistant depression and anhedonia.
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Takeda licences psychiatry programmes to Neurocrine Biosciences
pharmaceutical-technology
June 18, 2020
Takeda Pharmaceutical has collaborated with US-based Neurocrine Biosciences for the development and commercialisation of therapeutic compounds in its early-to-mid-stage psychiatry pipeline.