FDA approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania

The US FDA has approved AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US

Forest/Gedeon Richters Cariprazine effective in Acute Mania Associated with Bipolar I Disorder

Forest Laboratories  and Gedeon Richter have announced results from a phase II clinical trial of cariprazine (RGH-188) in patients with acute mania associated with bipolar I disorder. The data showed that patients with acute manic episodes treated with cariprazine experienced significant symptom improvement compared to placebo patients.

Alexza initiate 2nd phase III trial of AZ-004 in schizophrenia/bipolar disorder

Alexza has initiated a second Phase III trial of AZ-004 (Staccato, loxapine) for the treatment of acute agitation in patients with schizophrenia or bipolar disorder.

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.

FDA approves first generic risperidone

The FDA has approved the first generic versions of Risperdal (risperidone) tablets, manufactured by Teva.

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

FDA approves GSKs Requip XL for Parkinsons

The FDA has approved GSKs extended release formulation of Requip (ropinirole) for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

Jazz cut research staff and update on portfolio

Jazz Pharmaceuticals have announced that they will be reducing their workforce by 33 employees and will be focusing on the development of existing existing candidates rather than new drug discovery

JZP-6, Xyrem – Dopamine antagonist – Development continuing as normal. Phase III results in fibromyalgia expected in late 2008, NDA submission expected in 2009
JZP-8, Clonazepam – [...]

AstraZeneca submit European application for Seroquel XR in the treatment of Major Depressive Disorder

AstraZeneca have submitted a European application for Seroquel (quetiapine fumarate) extended release Tablets for the treatment of major depressive disorder

Axxonis submit MAA for Nedad (lisuride) transdermal patch and s.c. infusion

Axxonis Pharma have submitted a MAA for:
- Nenad lisuride transdermal patch for the add on treatment of Parkinson’s Disease and Restless Legs Syndrome
- Nenal subcutaneous lisuride infusion for advanced Parkinson’s Disease