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PEPFAR Scientific Advisory Board report offers six recommended research priorities

This post in the Center for Global Health Policy's "Science Speaks" blog examines a report by the PEPFAR Scientific Advisory Board (SAB) that offers six recommended treatment and prevention research priorities to U.S. Global AIDS Ambassador Eric Goosby and the Office of the Global AIDS Coordinator (OGAC) to guide future PEPFAR programs.

19 Nov 2011

Combo hormone therapy increases risk of breast cancer in women with new-onset tenderness

The debate about using menopausal hormone therapies to relieve symptoms in post-menopausal women has been ongoing. Is the combination therapy of estrogen and progestin better or worse than just giving women estrogen alone? In women who still have a uterus (those who have not had a hysterectomy), progestin counteracts the increased risk of uterus cancer when estrogen is given alone, but at the expense of an increase in breast cancer risk compared to estrogen alone.

19 Nov 2011

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

Merrimack Pharmaceuticals, Inc. announced today that the first patient has been dosed in a Phase 2 clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with erlotinib, a small molecule directed at the epidermal growth factor receptor (EGFR), in three groups of patients with metastatic non-small cell lung cancer.

18 Nov 2011

FDA Commissioner revokes approval of Genentech's Avastin for treatment of mBC

Genentech, a member of the Roche Group, announced today that the FDA Commissioner is revoking the approval of Avastin (bevacizumab) for the treatment of mBC in the United States.

18 Nov 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Tonix to initiate TNX-102 PK and BA study for fibromyalgia

Tonix Pharmaceuticals Holding Corp., a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system, including fibromyalgia syndrome and post-traumatic stress disorder, will initiate a comparative pharmacokinetic and bioavailability study of TNX-102, a novel dosage oral formulation of cyclobenzaprine for the treatment of FM, following the U.S. Food and Drug Administration clearance of the Company's initial Investigational New Drug Application.

18 Nov 2011

Inovio announces results from SynCon avian influenza vaccine Phase I study

Inovio Pharmaceuticals, Inc., which is advancing synthetic vaccines to fight cancers and infectious diseases, announced today that a single intradermal (ID) electroporation boost of its SynCon avian influenza vaccine generated HAI titers against six different, unmatched strains of H5N1 - a distinct new clinical achievement on the global research community's path to develop universal influenza vaccines.

18 Nov 2011

Biothera completes enrollment in Imprime PGG Phase II combination study on NSCLC

EBiothera's Phase II non-small cell lung cancer (NSCLC) clinical trial evaluating Imprime PGG administered in combination with cetuximab (Erbitux), carboplatin and paclitaxel has met its goal of 90 patients and is fully enrolled, the company announced today.

17 Nov 2011

Aurora kinase inhibitor may treat neuroendocrine prostate cancer

An international team of researchers led by clinicians at Weill Cornell Medical College have discovered a genetic Achilles' heel in an aggressive type of prostate cancer -- a vulnerability they say can be attacked by a targeted drug that is already in clinical trials to treat other types of cancers.

17 Nov 2011

Avraham raises $3M to advance ladostigil Phase II Alzheimer's trial

The drug, ladostigil, is a molecule that combines components from the existing drugs Azilect and Exelon. Teva's Azilect, for the treatment of Parkinson's disease, was developed by Prof. Emeritus Moussa Youdim of the Technion-Israel Institute of Technology. Azilect is the only anti-Parkinson's drug that has proven to have a disease-modifying effect. Novartis's Exelon was developed by Prof. Marta Weinstock-Rosin of Hebrew University to treat Alzheimer's disease.

17 Nov 2011

Mycophenolate mofetil superior to azathioprine for lupus nephritis

A new large, international study finds that the immunosuppressant drug mycophenolate mofetil is superior to azathioprine, an older immunosuppressant, as a maintenance therapy for lupus nephritis.

17 Nov 2011

New 2-DG-ABT combination cancer therapy triggers apoptosis

Researchers at the University of California, San Diego School of Medicine and Kyushu University Medical School say a novel combination of a specific sugar molecule with a pair of cell-killing drugs prompts a wide variety of cancer cell types to kill themselves, a process called apoptosis or programmed cell death.

17 Nov 2011

Bionovo initiates Menerba Phase 3 trial in menopausal hot flashes

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that the first patient has now been randomized and will begin dosing in the Phase 3 pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

17 Nov 2011

Additional results from BioSante's LibiGel pK study on HSDD

BioSante Pharmaceuticals, Inc., today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Top line data from this study were announced on September 12, 2011.

16 Nov 2011

First clinical trial of dapivirine-maraviroc ring to treat HIV in women

In the first clinical trial of a vaginal ring combining two antiretroviral (ARV) drugs, researchers from the Microbicide Trials Network (MTN) are collaborating with the International Partnership for Microbicides (IPM) to evaluate whether the ring is safe for use in women.

16 Nov 2011

NIAID's ACTG and TB Alliance partner to complete moxifloxacin Phase III trial

The TB Alliance announces the launch of a collaboration with the National Institute of Allergy and Infectious Diseases' (NIAID) AIDS Clinical Trial Group (ACTG) to conduct and help complete a Phase III clinical trial testing potentially faster-acting tuberculosis (TB) treatments.

16 Nov 2011

Rosuvastatin as effective as atorvastatin in reversing atherosclerosis

Maximum doses of Crestor- (rosuvastatin) or Lipitor- (atorvastatin) are similarly effective in reversing the buildup of cholesterol plaques in the coronary artery walls (atherosclerosis) after 24 months of treatment, according to Cleveland Clinic researchers.

16 Nov 2011

Amgen's XGEVA delays onset of bone metastases in men with prostate cancer

Amgen announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer.

16 Nov 2011

Alnylam announces new data from ALN-TTR01 Phase I trial on TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it will present new data from its ALN-TTR program at the VIIIth International Symposium on Familial Amyloidotic Polyneuropathy being held in Kumamoto, Japan from November 20-22, 2011.

15 Nov 2011

Pneumococcal vaccine Prevnar13 effective in seniors

Pneumococcal disease kills millions worldwide and the largest affected groups are children and the elderly. Federal health scientists now assure that the popular pneumococcal vaccine Prevnar is at least as effective as a rival vaccine at protecting adults from the sometimes-deadly infection.

15 Nov 2011