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Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

Labopharm Inc. today announced that Health Canada's Therapeutic Products Directorate (TPD) has approved OLEPTRO, a novel once-daily formulation of the antidepressant trazodone, for the symptomatic relief of Major Depressive Disorder in adults.

21 Jan 2011

Preliminary top-line results from levomilnacipran Phase III study for MDD

Forest Laboratories, and Pierre Fabre Medicament today announced preliminary top-line results from a Phase III study of levomilnacipran for the treatment of major depressive disorder.

20 Jan 2011

Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

Archimedes Inc., a healthcare modeling company, announced today that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

20 Jan 2011

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

ZIOPHARM Oncology, Inc., announced today that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL).

20 Jan 2011

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

Merck reported today that investigators in the TRA-2P study of vorapaxar have been provided with additional information about the recommendations of the Data and Safety Monitoring Board (DSMB) regarding the TRA-2P study. The additional information was sent yesterday in a communication to investigators from the Operations Committee of the TRA-2P study of vorapaxar. Vorapaxar is one of Merck's investigational cardiovascular medicines.

20 Jan 2011

GSK and Prosensa commence GSK2402968 Phase III study in DMD

GlaxoSmithKline and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968, in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.

20 Jan 2011

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Targacept, Inc. today announced positive top-line results from a Phase 2 clinical proof of concept trial to assess TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia.

20 Jan 2011

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Pluristem Therapeutics, Inc. today announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company's planned clinical development program for PLX-PAD.

19 Jan 2011

Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

ARIAD Pharmaceuticals, Inc., today announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

19 Jan 2011

Loyola offers new, nonsurgical treatment for Dupuytren's contracture

Loyola University Health System is among the first centers to offer a new, nonsurgical treatment for Dupuytren's contracture, a debilitating condition that curls fingers toward the palm.

19 Jan 2011

UMMS begins MBL-HCV1 Phase 2 trial to prevent hepatitis C virus infection in liver transplant patients

Following a successful Phase 1 study for safety, researchers at MassBiologics of the University of Massachusetts Medical School today announced the beginning of a Phase 2 clinical trial testing the ability of a human monoclonal antibody they developed to prevent hepatitis C virus infection of a donor liver in transplant patients.

19 Jan 2011

Antidepressant medication reduces frequency and severity of menopausal hot flashes

Women who were either in the transition to menopause or postmenopausal experienced a reduction in the frequency and severity of menopausal hot flashes with the use of the antidepressant medication escitalopram, compared to women who received placebo, according to a study in the January 19 issue of JAMA.

19 Jan 2011

PMT treatment with essential oils: Study

New research has shown that capsules containing a mixture of fatty acids can help relieve symptoms of PMT or Pre-Menstrual Tension - also known as Pre-Menstrual Syndrome (PMS). Women taking the two gram capsules over six months reported their emotional and physical symptoms becoming far milder than they were before.

18 Jan 2011

Cadence launches OFIRMEV pain medication in the U.S.

Cadence Pharmaceuticals, Inc. today announced the launch of OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

18 Jan 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

PecFent accepted in Scotland for treatment of breakthrough cancer pain

Archimedes Pharma Ltd., a leading international specialty pharma company, today announced the decision by the Scottish Medicines Consortium to accept PecFent for use within NHS Scotland. PecFent is indicated for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.

18 Jan 2011

Juice Plus+ reduces number of sick days, lowers expenditure on cold medicines: Study

University Medicine Berlin were the first to show that a specific food supplement made from fruit and vegetable juice concentrates significantly reduced the number of days with severe cold symptoms.

18 Jan 2011

Health Canada approves Eli Lilly's BYETTA for treatment of adults with type 2 diabetes

Eli Lilly Canada is pleased to announce the Health Canada approval of BYETTATM for the treatment of adults with type 2 diabetes.

18 Jan 2011

Diamyd commences NP2 Enkephalin Phase II trial to reduce cancer pain

Diamyd has dosed the first subject in a Phase II clinical trial in the United States evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain.

17 Jan 2011

Painkillers and heart attack risk

A new study has shown that taking certain commonly used painkillers for long periods or in high doses increases the risk of heart attacks or strokes. The study comes from researchers from Bern University and is published in the British Medical Journal.

16 Jan 2011

Placebo News and Research

Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

Preliminary top-line results from levomilnacipran Phase III study for MDD

Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

GSK and Prosensa commence GSK2402968 Phase III study in DMD

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

Loyola offers new, nonsurgical treatment for Dupuytren's contracture

UMMS begins MBL-HCV1 Phase 2 trial to prevent hepatitis C virus infection in liver transplant patients

Antidepressant medication reduces frequency and severity of menopausal hot flashes

PMT treatment with essential oils: Study

Cadence launches OFIRMEV pain medication in the U.S.

Alexza completes FDA review for AZ-004 NDA

PecFent accepted in Scotland for treatment of breakthrough cancer pain

Juice Plus+ reduces number of sick days, lowers expenditure on cold medicines: Study

Health Canada approves Eli Lilly's BYETTA for treatment of adults with type 2 diabetes

Diamyd commences NP2 Enkephalin Phase II trial to reduce cancer pain

Painkillers and heart attack risk

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