Vanda receive non approvable letter for Iloperidone

Vanda Pharmaceuticals have received a not approvable letter from the US FDA for iloperidone, an atypical antipsychotic under development for schizophrenia. The FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies.

Arenas APD-791 in Phase Ib for Arterial Thrombosis

Arenas APD-791 has been found to be well tolerated in a Phase Ib trial for Arterial Thrombosis. The drug dose-dependently inhibited of serotonin-mediated amplification of platelet aggregation

Lillys long acting injection olanzapine shows similar profile to Zyprexa

Data prsented at the Schizophrenia International Research Society meeting show Lilly’s long acting injection (LAI) formulation of olanzapine to demonstrate similar efficacy and safety to Zyprexa.

Acadias ACP-104 does not meet endpoint in Phase IIb Schizophrenia trial

Acadia’s ACP-104 did not meet its primary endpoint of antipsychotic efficacy in a Phase IIb Schizophrenia trial

Arenas 5-HT2A inverse agonist APD-125 shows efficacy in Insomnia

Phase II data presented at APD125 the Annual Meeting of the Associated Professional Sleep Societies show Arena’s 5-HT2a inverse agonist APD-125 to demonstrate efficacy in insomnia

Litmus Molecular Design create library of antipsychotic drug candidates

LITMUS Molecular Design has validated its Spectral Modeling technology with the deliverty of 5HT2A  antipsychotic drug candidates with confirmed predicted biological activities

Iloperidone shows efficacy in Phase III trial

Vanda Pharmaceutical’s 5HT2A/D2 antagonist has demonstrated efficacy with low rates of movement and metabolic adverse effects in a phase III trial in schizophrenia. It is currently under FDA review

Eplivanserin improves sleep quality in Phase III trial

Phase III results released by Sanofi Aventis demonstrate that Eplivanserin improves sleep quality. The drug also shows good tolerance versus placebo

Biovitrum completes study of BVT.28949 in Glaucoma

BVT.28949 was shown to reduce intraocular pressure over 4 weeks in a Phase II trial in patients with Glaucoma.