Tardive dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs. Neuroleptic drugs are generally prescribed for psychiatric disorders, as well as for some gastrointestinal and neurological disorders. Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano.
According to the new ruling from the U.S. Supreme Court, people harmed by generic drugs may find it harder to get restitution. The court ruled on Thursday that generic drug makers cannot be sued for failing to warn consumers of their products' side effects if they copy the exact warnings on the drugs' brand-name equivalents.
Neurocrine Biosciences, Inc. announced today that it has completed the dosing and preliminary assessment of the initial cohort of Tardive Dyskinesia patients using its proprietary Vesicular Monoamine Transporter 2 inhibitor, NBI-98854.
Sunovion Pharmaceuticals Inc. today announced the results of the PEARL 3 study, the third phase 3 worldwide clinical trial of Latuda® (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with schizophrenia. In this six-week, placebo-controlled trial, both fixed doses of LATUDA 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures.
Schizophrenia is a chronic and disabling brain disorder that affects 1 percent of the U.S. population and results in substantial medical and societal costs, in particular from use of health-care resources. It also can have devastating health-related and social effects on people with the disease, their families and caregivers.
Neurocrine Biosciences, Inc. today announced its financial results for the quarter ended September 30, 2010.
H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization agreement for SYCREST (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST in all markets outside the United States, China and Japan. Lundbeck expects to launch SYCREST in the European Union (EU), where it is already approved, at the beginning of 2011.
Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.
MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.
Mental disorders, such as depression, anxiety disorders, addiction and schizophrenia are the core challenge of most health care systems around the world. In the EU alone, each year 27% of the total adult population - this corresponds to 83 Million citizens - suffer from mental disorders. Depression alone affects almost 20 million ranking in the EU as the most disabling disorder of all diseases.
Mental disorders, such as depression, anxiety disorders, addiction and schizophrenia are the core challenge of most health care systems around the world. In the EU alone, each year 27% of the total adult population - this corresponds to 83 Million citizens - suffer from mental disorders. Depression alone affects almost 20 million ranking in the EU as the most disabling disorder of all diseases.
Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.
Recently, researchers have observed a disturbing trend in neonatal units across the country: doctors prescribing Reglan -- also known by its generic name, metoclopramide -- to treat premature infants. This alarming development has raised serious concerns from many consumer safety advocates, particularly because the drug was never approved for use in infants.
Neurocrine Biosciences, Inc. today announced its financial results for the quarter ended March 31, 2010. For the first quarter of 2010, the Company reported a net loss of $8.6 million, or $0.19 per share compared with a net loss of $19.7 million, or $0.51 per share, for the same period in 2009.
Vanda Pharmaceuticals Inc. announced today that the U.S. Patent and Trademark Office has issued a notice of allowance for its patent application of a microsphere, long-acting injectable formulation of its antipsychotic product, Fanapt™ (iloperidone). When issued, this U.S. patent will expire on October 30, 2022, and in addition, the U.S. Patent and Trademark Office has granted a patent term adjustment of 300 days, leading to an effective expiration date of August 26, 2023.
Neurocrine Biosciences, Inc. today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.
The U.S. Food and Drug Administration (FDA) approved ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company announced today.
Treatment with once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL® CONSTA®, according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.
The U.S. Food and Drug Administration (FDA) today approved Zyprexa® (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
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