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Lurasidone filed with EMA for schizophrenia

Dainippon Sumitomo Pharma (DSP) has said that the European Medicines Agency (EMA) has accepted for review Takeda's marketing authorisation application (MAA) for the oral atypical antipsychotic, lurasi...

EMA to review lurasidone for schizophrenia

Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said EMA accepted for review an MAA for lurasidone to treat schizophrenia. Takeda ha...

Method and Linearity Validation: A Consensus Approach

Addressing the lack of consensus procedure among regulatory bodies to perform systematic method and linearity validation

CVA and Cal-Chex Assays Add Instruments

Streck's CVA, an assayed linearity control kit used to determine the patient reportable range of 3-part and 5-part hematology instruments, is now assayed for the Beckman Coulter UniCel DxH 800, beginn...

DSPE Regulatory Update: Acceptance Of The European Medicines Agency Submission For An Atypical Antipsychotic Agent Lurasidone

Dainippon Sumitomo Pharma Europe Ltd ("DSPE") (Headquarters: London, UK) today announced that the European Medicines Agency (EMA) has confirmed that the Marketing Authorisation Application (MAA) for l...

Latuda lurasidone regulatory update

Prevention of the Phencyclidine-Induced Impairment in Novel Object Recognition in Female Rats by Co-Administration of Lurasidone or Tandospirone, a 5-HT1A Partial Agonist

Sunovion seeks FDA approval for LATUDA

Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA seeking approval for the use of LATUDA (lurasidone HCl) as monotherapy and adjunctive therapy in adult...

Evaluation of dopamine D(2)/D (3) and serotonin 5-HT (2A) receptor occupancy for a novel antipsychotic, lurasidone, in conscious common marmosets using small-animal positron emission tomography.

RATIONALE: Lurasidone is a novel antipsychotic drug with potent binding affinity for dopamine D(2) and serotonin (5-hydroxytryptamine, 5-HT)(2A), 5-HT(7), and 5-HT(1A) receptors. Previous pharmacologi...

The effects of selective antagonists of serotonin 5-HT7 and 5-HT1A receptors on MK-801-induced impairment of learning and memory in the passive avoidance and Morris water maze tests in rats: mechanistic implications for the beneficial effects of the novel

We have previously reported that lurasidone, a novel atypical antipsychotic with potent serotonin 5-HT(7) antagonist and 5-HT(1A) partial agonist activities, is superior to other antipsychotics in imp...

Quantification of lurasidone, an atypical antipsychotic drug, in rat plasma with high-performance liquid chromatography with tandem mass spectrometry.

A liquid chromatography-tandem mass spectrometric (LC/MS/MS) method was developed for the determination of an atypical antipsychotic drug, lurasidone, in rat plasma. The method involves the addition o...

Modulation of neuronal plasticity following chronic concomitant administration of the novel antipsychotic lurasidone with the mood stabilizer valproic acid.

RATIONALE: Combinatory therapy is widely used in psychiatry owing to the possibility that drugs with different mechanisms of action may synergize to improve functions deteriorated in schizophrenia, bi...

Interaction of mGlu(2/3) agonism with clozapine and lurasidone to restore novel object recognition in subchronic phencyclidine-treated rats.

RATIONALE: Subchronic administration to rodents of the N-methyl-D: -aspartate non-competitive antagonist, phencyclidine (PCP), impairs novel object recognition (NOR). Atypical antipsychotic drugs (APD...