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Arno AR-42 for neurofibromatosis type 2 receives EMA orphan-drug designation

Arno Therapeutics, Inc. announced today that its investigational compound known as AR-42 has been granted orphan-drug designation by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products for the treatment of neurofibromatosis type 2 (NF2).

11 May 2012

Top-line results from Takeda vedolizumab phase 3 trial on Crohn's disease

Takeda Pharmaceutical Company Limited today announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal phase 3 trial. The trial evaluated vedolizumab in 1,115 patients with moderately to severely active Crohn's disease who have failed at least one conventional therapy, including TNFα antagonists.

11 May 2012

Final results from Alnylam’s ALN-TTR01 Phase I trial on TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today final results from its completed Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis.

11 May 2012

Interim results from Seattle Genetics’ ADCETRIS phase II trial on CTCL

Seattle Genetics, Inc. today announced that interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC.

11 May 2012

NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that results from three phase III studies evaluating the use of continuous REVLIMID(lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine.

11 May 2012

Rituximab does not appear to benefit children with INS

The drug rituximab, an antibody that targets the immune system and is often used to treat immune disorders such as lymphoma and arthritis, has recently emerged as a potential treatment for a childhood kidney disorder known as idiopathic nephrotic syndrome.

11 May 2012

$Onconova advances rigosertib into new Phase II study for refractory MDS$

Onconova advances rigosertib into new Phase II study for refractory MDS

Onconova Therapeutics, Inc., announced today the advancement of the oral formulation of rigosertib, an anti-cancer agent with demonstrated activity in solid tumors and hematologic malignancies, into a new Phase II study. The intravenous (IV) formulation of rigosertib is currently in a pivotal Phase III trial for refractory myelodysplastic syndromes (MDS) in the U.S. and EU.

11 May 2012

Macrocure's CureXcell Shows Strong Efficacy and Safety in Phase IV Hard-To-Heal Wounds Trial

Cell therapy demonstrates high rate of complete closure of hard-to-heal wounds, including diabetic foot (DFU) and venous ulcers.

10 May 2012

Fast track approval process for “breakthrough” drugs proposed in the U.S.

Some experimental drugs that show a big effect early in development for treating serious or life-threatening diseases could soon get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.

10 May 2012

Leishmaniasis vaccine trial begins in U.S., India

"A vaccine against one of the most neglected yet fatal tropical diseases is being tested for the first time in a clinical trial in India and the U.S.," IRIN reports. Visceral leishmaniasis (VL), "also called kala-azar or black fever, infects an estimated half million persons or more annually," and "it is found most commonly in India, Nepal, Bangladesh, Brazil and Sudan," the news service notes.

10 May 2012

Hygieia’s DIGS automatically adjusts insulin dosage in patients with diabetes

Newly published results from a clinical study of the Diabetes Insulin Guidance System (DIGS-), under development by Hygieia, Inc., demonstrate DIGS' potential to improve blood glucose control for insulin-using patients with type 2 or type 1 diabetes. DIGS automatically adjusted insulin dosage based on each individual's reported blood glucose results.

10 May 2012

Sunovion announces results from LATUDA open-label study for schizophrenia

Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.

10 May 2012

Lenalidomide improves overall survival for patients with multiple myeloma

Data from the first large U.S. study assessing the effectiveness of long-term "maintenance" therapy with lenalidomide for patients with multiple myeloma show that the drug significantly improves the time to progression and overall survival for patients with this often-deadly hematologic cancer.

10 May 2012

IDRI, Aeras partner to develop new TB vaccine candidate

Aeras and the Infectious Disease Research Institute (IDRI) announce today a new agreement to conduct joint development activities with respect to IDRI's novel tuberculosis vaccine candidate. This collaboration reflects the missions of the two non-profit product development partnerships to use cutting-edge science to develop products that address critical diseases of underserved populations around the world, including tuberculosis.

10 May 2012

Resverlogix completes RVX-208 Phase 2b trial on CVD

Resverlogix Corp. is pleased to announce that dosing in SUSTAIN, a Phase 2b clinical trial to assess lipid trends and safety of RVX-208, has been completed on schedule.

10 May 2012

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.

10 May 2012

New study to measure effectiveness of Vitamin B12 in preventing gestational diabetes

New MRC-funded research underway to measure effectiveness of Vitamin B12 supplement in preventing gestational diabetes in mothers and obestity in later life.

9 May 2012

Provectus announces final data from PV-10 Phase 2 trial on metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announces that Phase 2 final data on PV-10 for metastatic melanoma will be presented at the 2nd European PostASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany.

9 May 2012

Sildenafil may improve cardiac function in children, young adults with single ventricle defects

Sildenafil, also known as the erectile dysfunction drug Viagra, may give a boost to underdeveloped hearts in children and young adults with congenital heart defects. Researchers from The Children's Hospital of Philadelphia report that sildenafil significantly improved echocardiographic measures of heart function in children and young adult survivors of single ventricle heart disease palliation.

9 May 2012

Antidepressives reduce risk of suicides in schizophrenic patients

Antidepressive drugs reduce the mortality rate of schizophrenic patients, while treatment with bensodiazepines greatly increases it, especially as regards suicide. Giving several antipsychotics simultaneously, however, seems to have no effect at all. This according to a new study examining different drug combinations administered to patients with schizophrenia.

9 May 2012