Serotonin News and Research

Latest Serotonin News and Research

FDA grants Impax tentative approval for generic Cymbalta NDA

Impax Laboratories, Inc. confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta® delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules.

22 Nov 2010

Scientists solve receptor structure that responds to neurotransmitter dopamine

A team led by scientists at The Scripps Research Institute has solved the structure of one of the receptors that responds to the neurotransmitter dopamine. Although dopamine transmission is essential to normal brain functioning, the biological assembly of the molecules involved in this crucial neuronal interplay had not been known until now.

19 Nov 2010

Neuralstem files NSI-189 IND with FDA for Phase I safety trials for major depression

Neuralstem, Inc. announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin two Phase I safety trials to test NSI-189, its first small molecule compound, for the treatment of major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression.

18 Nov 2010

New pharmacogenetic test enables a personalized medicine approach

Luminex Corporation, today announced that it has commercially launched its first pharmacogenetic test, the xTAG CYP2D6 Kit, which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

From Luminex 17 Nov 2010

Clinical Data receives U.S. patent for vilazodone

Clinical Data, Inc. today announced the issuance of U.S. Patent No. 7,834,020 claiming the polymorphic form of vilazodone (vilazodone HCl, Form IV), a compound currently in development for the treatment of Major Depressive Disorder.

16 Nov 2010

New findings suggest serotonin may have anti-diabetic property

New findings by researchers at UT Southwestern Medical Center suggest that serotonin a brain chemical known to help regulate emotion, mood and sleep might also have anti-diabetic properties.

11 Nov 2010

Adolor receives U.S. Patent for beloxepin to treat pain

Adolor Corporation today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,829,576 covering the use of ADL6906 (beloxepin), a small molecule, for the treatment of pain. The issued patent will expire on February 19, 2029.

11 Nov 2010

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP).

10 Nov 2010

Arena and Eisai report positive results from lorcaserin BLOOM-DM trial in obese, overweight diabetics

Arena Pharmaceuticals, Inc. and Eisai Inc. reported today that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, as described below, lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.

9 Nov 2010

Clinical Data receives $500,000 grants under QTDP program

Clinical Data, Inc. today announced that the Company has received two grants totaling nearly $500,000 under the Qualifying Therapeutic Discovery Project.

8 Nov 2010

Athersys secures three Therapeutic Discovery Project grants

Athersys, Inc. announced today that it has secured three Therapeutic Discovery Project grants as part of the Patient Protection and Affordable Care Act of 2010. These grants were awarded related to Athersys' development of MultiStem® for the treatment of acute myocardial infarction (AMI), also known as heart attack, and other forms of cardiovascular disease, as well as for the treatment of multiple diseases causing acute tissue damage and chronic inflammation.

4 Nov 2010

TriRima shows positive result in food-induced cardiovascular effects associated with MAO inhibitors

CeNeRx BioPharma, Inc., today announced that a new formulation of TriRima, its lead agent for treatment resistant depression, showed excellent safety in a study designed to test whether it is free of the food-induced cardiovascular effects associated with conventional MAO inhibitors.

2 Nov 2010

FDA grants Clinical Data's PRX-8066 Orphan Drug Designation for pulmonary arterial hypertension

Clinical Data, Inc. today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pulmonary arterial hypertension (PAH) to PRX-8066, the Company's selective serotonin 2B (5-HT2B) receptor antagonist.

1 Nov 2010

ACADIA and BLS enter agreement to conclude pimavanserin collaboration

ACADIA Pharmaceuticals Inc. today announced that it has entered into an agreement with Biovail Laboratories International SRL ("BLS"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., pursuant to which ACADIA and BLS have agreed to conclude their previously established collaboration to develop and commercialize pimavanserin in the United States and Canada.

29 Oct 2010

Arena's NDA receives Complete Response Letter for lorcaserin

Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese

25 Oct 2010

Researchers suggest gene therapy may treat patients with major depression

In a report published in the Oct. 20 issue of Science Translational Medicine, researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center say animal and human data suggest gene therapy to the brain may be able to treat patients with major depression who do not respond to traditional drug treatment.

22 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

Researcher hopes to provide effective medication for Parkinson's disease

The side effects of the standard medication for Parkinson's disease have long been a preoccupation of brain researchers. Now Daniella Rylander has presented new findings in a recently defended PhD thesis at Lund University that provide hope of more effective medication for those who suffer from the nerve cell disease.

21 Oct 2010

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $1.00 in the second quarter of fiscal 2011.

19 Oct 2010

Novel bioelectric signals can cause stem cells to trigger melanoma-like growth in pigment cells

Biologists at Tufts University School of Arts and Sciences have discovered that a change in membrane voltage in newly identified "instructor cells" can cause stem cells' descendants to trigger melanoma-like growth in pigment cells. The Tufts team also found that this metastatic transformation is due to changes in serotonin transport. The discovery could aid in the prevention and treatment of diseases like cancer and vitiligo as well as birth defects.

19 Oct 2010