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Aripiprazole (marketed as Abilify, Abilify Discmelt) is an atypical antipsychotic medication approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.
Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes plc today announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo (p<0.001 aripiprazole lauroxil 441 mg, p<0.001 aripiprazole lauroxil 882 mg), which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014. [More]
Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia. [More]
Otsuka Acquires Astex For $866M

Otsuka Acquires Astex For $866M

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Omeros' GPCR platform unlocks new drug targets against multiple sclerosis

Omeros' GPCR platform unlocks new drug targets against multiple sclerosis

Omeros Corporation today announced positive data in the most commonly used model for studying the clinical and pathological features of multiple sclerosis (MS), further advancing its development program of GPR17-targeting compounds for the treatment of MS. Compounds previously discovered by Omeros that inhibit GPR17, an orphan G protein-coupled receptor (GPCR) unlocked by Omeros, significantly improved function from experimental autoimmune encephalomyelitis (EAE) in mice. [More]
Lundbeck, Otsuka reach agreement to develop and commercialize Lu AE58054

Lundbeck, Otsuka reach agreement to develop and commercialize Lu AE58054

H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. today announced a license and development agreement for Lu AE58054, a selective 5HT6 receptor antagonist currently in development for the treatment of Alzheimer's disease. [More]
Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia. [More]

Off label atypical antipsychotic use lacks safety and effectiveness in patients over 40

In older adults, antipsychotic drugs are commonly prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications - schizophrenia and bipolar disorder. The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia, some of which carry FDA warnings on prescription information for these drugs. [More]

Newly diagnosed schizophrenia patients continue to use oral Abilify as first-line therapy

BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that analysis of U.S. longitudinal patient-level claims data reveals the use of Bristol-Myers Squibb's oral Abilify as a first-line therapy for newly diagnosed schizophrenia patients continues to grow. [More]
Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia. [More]

Alkermes commences ALKS 9070 phase 3 clinical trial for schizophrenia

Alkermes plc today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system disorders. [More]
First-ever comprehensive study of species origins of nature-derived drugs

First-ever comprehensive study of species origins of nature-derived drugs

In a first-ever comprehensive study of the species origins of nature-derived drugs, it is shown that drug-producing species are concentrated and clustered in a limited number of families, refuting the conventional view that as every nature species produces biologically active molecules, one can find drugs from almost any major block of species groups if one looks for them hard enough. [More]
CDR recommends reimbursement for schizophrenia drug, ABILIFY

CDR recommends reimbursement for schizophrenia drug, ABILIFY

Bristol-Myers Squibb Canada is pleased to announce that the Common Drug Review (CDR) has recognized the value of ABILIFY® (aripiprazole) for the treatment of schizophrenia and schizoaffective disorders by recommending it be reimbursed by provincial drug plans for patients who have a contraindication to less-expensive antipsychotic agents or who have failed a trial of less expensive antipsychotic agents due to intolerance or lack of response. [More]

Positive topline results from Alkermes ALKS 9070 phase 1b study for schizophrenia

Alkermes, Inc. today announced positive topline results from a phase 1b, double-blind, randomized, placebo-controlled study of ALKS 9070 in patients with schizophrenia. [More]
Omeros identifies compounds that interact with orphan GPCRs associated with leukemia

Omeros identifies compounds that interact with orphan GPCRs associated with leukemia

Omeros Corporation today reported that it has identified compounds that interact with orphan G protein-coupled receptors (GPCRs) P2Y8 and OPN4. P2Y8 (also known as P2RY8) is associated with acute lymphoblastic leukemia (ALL), an aggressive cancer of the white blood cells. [More]
Bristol-Myers Squibb first quarter net sales increase 5% to $3.3 billion

Bristol-Myers Squibb first quarter net sales increase 5% to $3.3 billion

Bristol-Myers Squibb Company today announced first quarter results that included strong sales and earnings growth, and several key R&D milestones—most notably U.S. regulatory approval for YERVOY. The company also confirmed guidance for the year. [More]
America’s best loved drugs: Report

America’s best loved drugs: Report

According to the latest report from consulting firm IMS Health, Americans are consuming a lot of prescription drugs. And they seem especially fond of those to lower their cholesterol, relieve heartburn, aid in depressive disorders and lessen pain. Overall, however, their spending on such drugs is slowing. [More]
Omeros identifies orphan GPCR compounds associated to pancreatic cancer, cognitive disorders

Omeros identifies orphan GPCR compounds associated to pancreatic cancer, cognitive disorders

Omeros Corporation today announced that it has identified compounds that interact selectively with two orphan G protein-coupled receptors linked to pancreatic cancer and cognitive disorders. [More]

Two surveys show 'huge variation' in health costs in U.S.

The Wall Street Journal: Two studies out Monday - one is a country-by-country survey by the International Federation of Health Plans, and the second from Change: healthcare - "attempt to bring some clarity to how costs stack up, both between different countries and among U.S. providers that might be just a few blocks apart." [More]

District Court judgment favors Otsuka in Abilify patent litigation

Otsuka Pharmaceutical Co., Ltd. and Otsuka Holdings, Co., Ltd., the parent company of Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. District Court for the District of New Jersey issued its judgment dated November 15, 2010 in favor of Otsuka Pharmaceutical Co., Ltd. in its patent litigation against several companies seeking FDA approval to market generic copies of Abilify. [More]
Omeros identifies orphan GPCR compound that potentiates tumor-killing activity of doxorubicin

Omeros identifies orphan GPCR compound that potentiates tumor-killing activity of doxorubicin

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that a compound identified by the Company as an antagonist of GPR87, an orphan GPCR recently unlocked for drug development by Omeros and linked to squamous cell carcinoma, potentiates the tumor-killing activity of doxorubicin (Adriamycin), a widely used chemotherapeutic agent. [More]