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Pfizer terminates Lyrica Phase 3 trial on neuropathic pain associated with HIV neuropathy

Pfizer Inc. announced today that it has stopped a Phase 3 clinical trial of Lyrica (pregabalin) in patients with neuropathic pain associated with HIV neuropathy, a form of nerve damage characterized by burning pain usually beginning in the feet. The decision follows review of a planned interim analysis of the study by the trial's external Data Monitoring Committee.

5 May 2012

Isis commences ISIS-APOCIIIRx Phase 2 study in hypertriglyceridemia

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 2 study evaluating ISIS-APOCIIIRx in patients with hypertriglyceridemia.

5 May 2012

Pfizer’s Lyrica Phase 3 study on pDPN fails to meet primary endpoint

Pfizer Inc. announced today that a Phase 3 randomized withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy (pDPN) did not meet its primary efficacy endpoint, change in endpoint mean pain score relative to baseline.

5 May 2012

New analysis may help identify breast cancer patients who will benefit from immune suppressant

A new analysis may help doctors identify breast cancer patients who will benefit from treatment with the immune suppressant drug everolimus, say French researchers at the 4th IMPAKT Breast Cancer Conference in Brussels, Belgium.

4 May 2012

CSL Behring commences C1-INH phase I/II study in hereditary angioedema

CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema.

4 May 2012

Generon commences F-627 Phase II trial in breast cancer

Generon Corporation Ltd. today announced the initiation of a Phase II clinical trial for F-627 after US FDA regulatory clearance. The current study is a Phase II, randomized, multicenter, open-label, active-controlled trial of F-627 in women with breast cancer receiving myelotoxic chemotherapy.

4 May 2012

Abbott to purchase AP214 hormone analogue from Action Pharma

Abbott and Action Pharma A/S, a privately owned company, today announced that they have entered into an agreement in which Abbott will acquire AP214 from Action Pharma.

4 May 2012

Clinical trial to investigate statins in patients with acute severe respiratory failure

Queen's University and NUI Galway and are leading a clinical trial to investigate the possibility that statins, a drug commonly used to combat cholesterol, might help patients with acute severe respiratory failure.

4 May 2012

Varenicline reduces alcohol intake among heavy-drinking smokers

The smoking cessation drug varenicline significantly reduced alcohol consumption in a group of heavy-drinking smokers, in a study carried out by researchers at the Ernest Gallo Clinic and Research Center at the University of California, San Francisco.

4 May 2012

Lexicon to receive funding for LX4211 Phase 2 trial in type 1 diabetes

Lexicon Pharmaceuticals, Inc. announced today that an independent, non-profit organization will provide funding to support the Phase 2 development of LX4211 in type 1 diabetes.

4 May 2012

GenVec receives NIAID’s Phase I SBIR grant to support RSV vaccine program

GenVec, Inc. announced today that it has received a Phase I Small Business Innovation and Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to support the Company's Respiratory Syncytial Virus (RSV) vaccine program.

4 May 2012

NCIC CTG, Oncolytics to conduct REOLYSIN Phase II study in colorectal cancer

Oncolytics Biotech Inc. announced today that it has entered into an agreement whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct a randomized Phase II study of REOLYSIN in patients with advanced or metastatic colorectal cancer.

4 May 2012

HiLo trial sets new gold standard for thyroid cancer treatment

The results of a large Cancer Research UK trial have set a new gold standard for treating thyroid cancer, reducing radiation doses to just one third of the current level, according to research in The New England Journal of Medicine.

3 May 2012

SC formulation of Genentech’s ACTEMRA shows promise against RA

Genentech, a member of the Roche Group, today announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy (non-inferiority) of the subcutaneous (SC) formulation of ACTEMRA (tocilizumab) 162mg weekly compared to 8 mg/kg ACTEMRA intravenous (IV) formulation every four weeks.

3 May 2012

Physician Therapeutics publishes results from Sentra PM clinical trial

Physician Therapeutics, Inc., a division of Targeted Medical Pharma, Inc., a specialty pharmaceutical company that manufactures and distributes specialty pharmaceuticals to physicians, pharmacies and skilled nursing facilities, published results from a clinical trial of the proprietary medical food Sentra PM.

3 May 2012

German BfArM grants Moberg Derma approval to initiate Limtop phase II actinic keratosis trial

The German Federal Institute for Drugs and Medical Devices (BfArM) has granted Moberg Derma approval to initiate a clinical phase II trial for Limtop. The aim is to evaluate the efficacy and safety of three different dose regimens of Limtop in a study involving 96 patients with Actinic Keratosis (AK) on the head or face.

2 May 2012

ImmuVen awarded $1.68M NIH Phase II SBIR grant to develop IMV0123

ImmuVen was awarded a Phase II Small Business Innovation Research (SBIR) grant totaling $1.68 million from the National Institute for Allergy and Infectious Disease (NIH) for continuing development of its therapeutic pipeline (IMV0123) against superantigens produced by methicillin-sensitive and methicillin-resistant Staphylococcal aureus.

2 May 2012

Fish oil may improve outcomes for kidney patients undergoing hemodialysis

Over the past decade, there has been a steady stream of information promoting the health benefits of fish oil capsules. According to Dr. Louise Moist, a Scientist at Lawson Health Research Institute, fish oil may also improve outcomes for kidney patients undergoing hemodialysis.

2 May 2012

JLGTD to publish results from Cutaneous Lysate study on vulvodynia

The results from Dr. Gilbert G. Donders' MD, PhD study testing Cutaneous Lysate in women suffering from vulvar pain has been accepted for publication in the Journal of Lower Genital Tract Disease.

2 May 2012

Topline, interim results from Celldex Phase 2b EMERGE study of CDX-011 for advanced breast cancer

Celldex Therapeutics, Inc. today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast Cancer Research Program at Weill Cornell Medical College and the lead investigator of the EMERGE study, will join Celldex on the webcast to discuss data from the study.

2 May 2012