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Archimedes publishes FPNS clinical study results in Pain journal

Archimedes Pharma US Inc. today announced publication of results from a pivotal clinical study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain (BTCP).

5 Oct 2010

Preclinical data of Enzon's PEG-SN38 in pediatric neuroblastoma published in Clinical Cancer Research

Enzon Pharmaceuticals, Inc. today announced the publication of preclinical data demonstrating that PEG-SN38 (EZN-2208), the Company's novel PEGylated DNA topoisomerase I inhibitor, led to significantly greater tumor regression as compared to CPT-11 (irinotecan) in both in vitro and in vivo models of pediatric neuroblastoma.

5 Oct 2010

Intellect Neurosciences receives patent for Alzheimer's disease monoclonal antibody program

Intellect Neurosciences, Inc., a biopharmaceutical company with internal preclinical and clinical-stage pipelines, as well as multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has received a patent from the United States Patent and Trademark Office (USPTO) related to its internal Alzheimer's disease (AD) monoclonal antibody program.

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

Supplemental brief dynamic therapy does not benefit patients with obsessive-compulsive disorder: Study

This study demonstrates that supplemental brief dynamic therapy in the treatment of patients with obsessive compulsive-disorder with concurrent major depressive disorder (who are receiving effective medication) has no significant clinical effect on both obsessive and depressive symptoms.

5 Oct 2010

Black mothers less likely to initiate and continue breastfeeding: Study

While more American mothers are breastfeeding today, non-Hispanic Black/African American women are less likely to initiate and continue breastfeeding, primarily due to a lack of desire and lack of self-efficacy, according to research presented Monday, Oct. 4, at the American Academy of Pediatrics (AAP) National Conference and Exhibition in San Francisco.

5 Oct 2010

RHUCIN clinical trial results published in JACI journal

Santarus, Inc., a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).

5 Oct 2010

CrystalGenomics to present Phase I MAD study data at Arrowhead Summit

CrystalGenomics, Inc. and CG Pharmaceuticals, Inc. a drug discovery and development biopharmaceutical company, has announced that Dr. William Schmidt, its Vice President of Clinical Development, has been invited to present a talk on Development of CG100649, Tissue-selective Dual Inhibitor of COX-2 and Carbonic Anhydrase for Treatment of Osteoarthritis at Arrowhead's upcoming 4th Annual Pain Therapeutics Summit, to be held on October 4-5, 2010 in Philadelphia.

5 Oct 2010

Aeras Global receives FDA grant to develop biomarkers for TB vaccine

The Aeras Global TB Vaccine Foundation is pleased to announce receipt of a grant from the United States Food and Drug Administration (FDA) to develop new biological and immunological biomarkers for TB vaccine development. The FDA grant, which supports the coordination of a multi-investigator project with researchers from the United States, the United Kingdom and South Africa, will provide $362,102 in the first year of funding.

5 Oct 2010

NIH awards contract to develop nanotechnology tools for atherosclerosis treatment

Georgia Tech and Emory University have received a five-year $14.6 million contract from the National Institutes of Health (NIH) to continue the development of nanotechnology and biomolecular engineering tools and methodologies for detecting and treating atherosclerosis.

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

In its November meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider Novo Nordisk's second-to-market glucagon-like peptide-1 (GLP-1) agonist Victoza for reimbursement, which would be essential in order for the drug to compete effectively with Eli Lilly's Byetta. However, its chances of success are uncertain, considering that it took three years to get Byetta on the Pharmaceutical Benefits Scheme (PBS).

4 Oct 2010

Depression treatment guidelines updated

There has been an update in the treatment of clinical depression. This includes suggestions on the use of medication, talk therapy, exercise, and alternative treatments and puts more emphasis on tailor made treatments for patients.

4 Oct 2010

FDA clears DFine's new percutaneous radiofrequency ablation device for metastatic spinal lesions

DFine, Inc., developer of minimally invasive solutions for the treatment of vertebral pathologies, announced today the 510(k) clearance of a new platform extension indicated for the palliative treatment of cancer patients. The product, a percutaneous radiofrequency ablation (RFA) device, provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort.

4 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

Rate of chemotherapy administration for NSCLC more than twice that reported by SEER

For the first time to date, research published in the October edition of the Journal of Thoracic Oncology (JTO) sought to determine the use of chemotherapy in a contemporary, diverse non-small cell lung cancer (NSCLC) population encompassing all patient ages. Prior population-based studies have shown that only 20 to 30 percent of advanced lung cancer patients receive chemotherapy treatment.

4 Oct 2010

Mandatory ECG screening for athletes

Should athletes have to undergo mandatory electrocardiographic screening (also known as ECG or heart trace) before competing? Doctors debate the issue in this week's BMJ.

4 Oct 2010

UCI awarded $10M grant to explore ways of preventing staph infections in people harboring MRSA bacteria

A UC Irvine infectious disease specialist has received a three-year, $10 million grant to explore the effectiveness of new methods to prevent staph infections in people who harbor MRSA bacteria when they're discharged from the hospital.

4 Oct 2010

Efficacy News and Research

Archimedes publishes FPNS clinical study results in Pain journal

Preclinical data of Enzon's PEG-SN38 in pediatric neuroblastoma published in Clinical Cancer Research

Intellect Neurosciences receives patent for Alzheimer's disease monoclonal antibody program

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Supplemental brief dynamic therapy does not benefit patients with obsessive-compulsive disorder: Study

Black mothers less likely to initiate and continue breastfeeding: Study

RHUCIN clinical trial results published in JACI journal

CrystalGenomics to present Phase I MAD study data at Arrowhead Summit

Aeras Global receives FDA grant to develop biomarkers for TB vaccine

NIH awards contract to develop nanotechnology tools for atherosclerosis treatment

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

Depression treatment guidelines updated

FDA clears DFine's new percutaneous radiofrequency ablation device for metastatic spinal lesions

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Rate of chemotherapy administration for NSCLC more than twice that reported by SEER

Mandatory ECG screening for athletes

UCI awarded $10M grant to explore ways of preventing staph infections in people harboring MRSA bacteria

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