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Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Immune Network, a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor, has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis conducted at its second site in Ukraine.

24 Jan 2011

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

R-Tech Ueno, is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Scientists ignore relevant drug clinical trials when conducting new research on same topic

The vast majority of already published and relevant clinical trials of a given drug, device or procedure are routinely ignored by scientists conducting new research on the same topic, a new Johns Hopkins study suggests.

24 Jan 2011

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Biogen Idec announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.

21 Jan 2011

Major breakthrough: Genome-based medicine for treatment of alcoholism

For the first time in alcohol addiction research, UVA investigators have successfully treated alcohol-dependent individuals with medication that is tailored specifically to match their genetic profile.

21 Jan 2011

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

Placebo News and Research

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

SuppreMol completes successful pre-IND meeting with U.S. FDA

Scientists ignore relevant drug clinical trials when conducting new research on same topic

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Major breakthrough: Genome-based medicine for treatment of alcoholism

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.

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