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Positive results from Alkermes’ ALKS 5461 phase 1/2 study on MDD

Alkermes plc today presented positive results from the phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52nd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Phoenix.

30 May 2012

FDA accepts NDA filing for KYNAMRO to treat HoFH

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., announced today that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).

29 May 2012

Oncos Therapeutics commences clinical study with oncolytic viruses

Oncos Therapeutics today announced the successful initiation of its Phase I clinical study of CGTG-102, an oncolytic adenovirus suggested as a potential new treatment for many types of solid tumors.

29 May 2012

Spectrum initiates enrollment in RenaZorb Phase 1 trial in healthy volunteers

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb in healthy volunteers.

29 May 2012

Enrollment complete in Advaxis’ ADXS-HPV Phase 2 trial for cervical cancer

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that it has completed enrollment in Lm-LLO-E7-15, the 110 patient, randomized Phase 2 trial of ADXS-HPV in women with recurrent/refractory cervical cancer who have failed cytotoxic therapy.

29 May 2012

Abbott to highlight latest investigational research findings on HUMIRA at EULAR 2012

Abbott scientists and independent researchers will highlight the latest investigational research findings on HUMIRA (adalimumab) at the European League Against Rheumatism (EULAR) Congress in Berlin, Germany, from 6-9 June, 2012.

29 May 2012

Positive results from Acacia Phase II APD421 study in prevention of post-operative nausea & vomiting

Acacia Pharma announces positive results from its Phase II study of APD421, in the prevention of post-operative nausea & vomiting (PONV).

28 May 2012

Medivir initiates MIV-711 phase I trial in bone disorders

Medivir AB, a research-based pharmaceutical company focused on infectious diseases, announced today that a phase I clinical trial has been initiated with its investigational drug, MIV-711, a cathepsin K inhibitor for the treatment of bone disorders characterized by excessive bone resorption such as osteoporosis, osteoarthritis and bone metastases.

28 May 2012

AngioPredict project to focus on patients with metastatic colorectal cancer

The Royal College of Surgeons in Ireland (RCSI) is leading an international team of scientists on a major research study which aims to predict colorectal cancer patients' response to the 'angiogenesis inhibitor' class of anti-cancer drug which prevents growth of tumour blood vessels. The study will facilitate a more focused therapeutic approach thus limiting side-effects in patients.

28 May 2012

Tβ4 offers both neurorestoration and neuroprotection after TBI

RegeneRx Biopharmaceuticals, Inc. reported that data showing that Thymosin beta 4 (Tβ4) "provides both neuroprotection and neurorestoration after traumatic brain injury (TBI)," was published in the current (May 2012) edition of the Journal of Neurosurgery, 116:1081-1092.

28 May 2012

Positive results from Sanofi and Regeneron’s SAR236553/REGN727 Phase 2 trial on heFH

Sanofi and Regeneron Pharmaceuticals, Inc. today announced additional positive results from a Phase 2 trial of SAR236553/REGN727 in patients with heterozygous familial hypercholesterolemia (heFH).

28 May 2012

ESRD patients with diabetes may benefit from Baxter’s low-glucose PD regimen

Baxter International Inc. today announced results from two large, international multicenter trials demonstrating that a low glucose peritoneal dialysis (PD) regimen favorably impacted metabolic measures important for end-stage renal disease (ESRD) patients with diabetes, including blood glucose (sugar) control and selected lipids.

From Baxter International Inc. 28 May 2012

Linagliptin safe and effective for African American patients with type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced Phase 3 study results for linagliptin 5 mg once-daily, which showed significant hemoglobin A1c (HbA1c or A1C) reduction of 0.88 percent compared to 0.24 percent in the placebo group (p=0.0002) at 24 weeks in black or African American adult patients with type 2 diabetes whose blood sugar was not adequately controlled.

25 May 2012

Insmed initiates patient screening for ARIKACE phase 2 NTM lung disease trial

Insmed Incorporated, a biopharmaceutical company, today announced that it has begun screening patients for its U.S. phase 2 clinical trial, Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM), of ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.

24 May 2012

ICS may prevent parapneumonic effusion in patients with CAP

Prior treatment with inhaled corticosteroids in patients with respiratory disorders who develop community acquired pneumonia (CAP) is associated with a lower incidence and severity of parapneumonic effusion, according to a new study from researchers in Spain.

24 May 2012

Preliminary results from Celldex’s CDX-011 Phase 2b breast cancer study

Celldex Therapeutics, Inc. today announced preliminary results from the Company's randomized Phase 2b EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression.

24 May 2012

Azithromycin can be effective treatment option for patients with BOS

Researchers in the United Kingdom have determined that azithromycin, a broad-spectrum antibiotic that also has anti-inflammatory properties, can be an effective treatment option for patients suffering from bronchiolitis obliterans syndrome (BOS), a life-threatening complication that occurs in the majority of patients following lung transplantation.

24 May 2012