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CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
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Schizophrenia
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FDA approves long-acting injectable for schizophrenia and bipolar disorder
Schizophrenia and bipolar I disorder patients can be offered Rykindo® as a bi-weekly long-acting risperidone injection, as a result of the FDA's approval.
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Promising schizophrenia drug faces tough competition
A schizophrenia drug that could reduce the risk of patient relapse is at risk of being hidden in a crowded long-acting injectable market.
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Green HPLC method enables antipsychotic determination
EPR highlights a green high performance liquid chromatography (HPLC) method that successfully determined four common antipsychotics in formulation.
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FDA approves Invega Hayfera™ for the treatment of schizophrenia
Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.
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Novel anti-psychotic shows promise in Phase II schizophrenia trial
KarXT significantly reduced both positive and negative of symptoms of schizophrenia without the common problematic side effects of current antipsychotic therapies.
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-300x278.jpg)
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-e1612534960797.jpg)
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Jazz to acquire GW Pharmaceuticals for $7.2 billion
According to Jazz Pharmaceuticals, the combined company will be a leader in neuroscience, well positioned to maximise the value of its diversified portfolio.
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New system could deliver schizophrenia medicine directly to brain
A team has created a nasal spray as a drug delivery system to get schizophrenia medication directly to the brain.
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CVN058 shows promise in Phase Ib schizophrenia cognition study
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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EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
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MHRA issues Medicine Defect Information about Aripiprazole
The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.
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MHRA issues alert for missing information on Atrolak XL tablet leaflets
Side effects revealed during post-marketing experience are not listed on Atrolak XL prolonged-release tablet patient information leaflets, announces the MHRA.
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Heritage announces product recall after sterility test failure
Heritage has recalled two of its injectable treatments after microbial growths were found.
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FDA approves Aristada Inito for the initiation of Aristada for schizophrenia
Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one...
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Study examines antipsychotic medication for children with autism
Children with intellectual difficulty or autism are more likely to be given antipsychotic medication from a younger age than those without intellectual disability...
