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FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

MannKind Corporation today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind's resubmission of its New Drug Application for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act action date of December 29, 2010.

21 Jul 2010

Ingestion of probiotic supplements prevents eczema: Study

Mothers who drank milk with a probiotic supplement during and after pregnancy were able to cut the incidence of eczema in their children by almost half,a new study published in the British Journal of Dermatology has shown.

21 Jul 2010

World-first dialysis study set to reduce health costs

The results of a world-first controlled trial of dialysis start-time in patients with Stage V chronic kidney disease is set to have major impact on the cost and infrastructure of chronic kidney disease (CKD) treatment and dialysis services.

20 Jul 2010

ARUP announces new version of Septin 9 methylated DNA test

ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, today announced it is offering the Septin 9 methylated DNA test, a new blood-based colorectal cancer screening method. While ARUP is not the first laboratory to offer this test, this new version, developed and validated independently by ARUP, is clinically proven to detect a higher proportion of colorectal cancers than Septin 9 tests developed by other companies.

20 Jul 2010

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced top-line results from a successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558 program is now poised to enter Phase 3 studies.

20 Jul 2010

SDIX announces multi-year collaboration with Banyan Biomarkers

SDIX, today announced a multi-year collaboration with Banyan Biomarkers, Inc. to provide products and services for Banyan's biomarker discovery work in the detection of traumatic brain injury.

20 Jul 2010

Winston Laboratories receives NOC for CIVANEX

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has received Notice of Compliance from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.

20 Jul 2010

Archer Biosciences initiates third drug-escalation cohort in TPI-287 trial for metastatic melanoma

Archer Biosciences, Inc. announced that the trial of its novel, proprietary drug TPI-287 (an abeotaxane) for the treatment of metastatic melanoma has initiated a third drug-escalation cohort. The primary objective of this study is to determine the safety, tolerability and maximum tolerated dose (MTD) of TPI-287 in combination with temozolomide (TMZ) in adult patients with metastatic melanoma.

20 Jul 2010

KAI Pharmaceuticals completes enrollment in Phase 1 study of KAI-4169 for SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced the Company has completed enrollment in a Phase 1 study of KAI-4169, a novel pharmaceutical agent for the treatment of secondary hyperparathyroidism, which is a frequent complication of end stage renal disease.

20 Jul 2010

Seattle Genetics, Agensys commence ASG-5ME ADC phase I clinical trial for metastatic pancreatic cancer

Seattle Genetics, Inc. and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.

20 Jul 2010

Fero Industries provides comments concerning FDA advisory panel recommendation on diabetes drug Avandia

Fero Industries, Inc. is pleased to provide these comments regarding the recent Food and Drug Administration advisory panel recommendation concerning the GlaxoSmithKline PLC diabetes drug Avandia. The FDA advisory panel has recommended that the agency keep diabetes drug Avandia on the U.S. market despite data clearly showing an increased risk of a heart attack and that GSK covered up their own research that first identified the problem.

20 Jul 2010

Acorda Therapeutics awarded $1M C-TRIP grant to support research on GGF2

Acorda Therapeutics, Inc. today announced the National Heart, Lung, and Blood Institute has awarded a $1 million Cardiac Translational Research Implementation Program grant to support research on Glial Growth Factor 2, a novel investigational agent for the treatment of patients with heart failure under development at Acorda.

20 Jul 2010

Frameless radiosurgery can treat most sensitive regions of brain: Study

While four in 10 clinicians use frameless radiosurgery exclusively to treat cranial indications, user data collected at the 5th International Conference of the Novalis Circle, held last month in Munich, Germany, shows that there are still significant opportunities to increase utilization of the effective treatment approach.

20 Jul 2010

Diffused ultraviolet radiation penetrates beach umbrellas

A team of researchers from the University of Valencia (UV) has proven that 34% of ultraviolet radiation filters through under beach umbrellas. According to what is published in the journal Photochemistry and Photobiology, umbrellas intercept the full direct flow that comes from the Sun, but not the diffused radiation that penetrates through from the sides.

20 Jul 2010

Heart patients living with children exercise less: Study

A study conducted at the Montreal Heart Institute (MHI) has shown unexpectedly that living with children is linked to a reduction in physical activity. Carried out with 756 participants and led by Dr. Simon L. Bacon, Associate Researcher at the MHI and Professor at Concordia University, the study assessed the impact of social networks on exercise, revealing that people with heart disease who live with children exercise less than those people who do not live with children.

20 Jul 2010

ASTRO accepts 4 abstracts on Stereotactic Body Radiation Therapy for NSCLC

The American Society for Radiation Oncology (ASTRO) has accepted four abstracts from users of Elekta Stereotactic Body Radiation Therapy (SBRT) technology on the use of SBRT to treat non-small cell lung cancer (NSCLC). The clinicians will present their findings during presentations at ASTRO's 52nd Annual Meeting (October 31 - November 4) at the San Diego Convention Center.

From Elekta 20 Jul 2010

New report on neuropsychiatric link with ophthalmologic investigations

Regardless of culture, language, era, or individual artist, the arts consistently depict depression using darkness. Scientific findings now lend empirical support to this representation of depression that everything looks gray when you feel blue.

20 Jul 2010

Tool kit for non-experts to measure ADA compliance

Twenty years after the signing of the Americans with Disabilities Act, there is finally a "tool kit" for non-experts to measure whether public facilities are in compliance.This is designed to meet the needs of anyone who is reasonably intelligent but not necessarily a techie,explains Denis Anson, director of research for the Assistive Technology Research Institute (ATRI) at Misericordia University in Dallas, Pennsylvania, and the kit's developer.

20 Jul 2010

Aegera reports data from Phase 1 portion of combination AEG35156 Phase 1-2 study for primary liver cancer

Aegera Therapeutics Inc. released today encouraging survival data from the Phase 1 portion of its Phase 1-2 Study of the novel targeted therapeutic, AEG35156, given in combination with sorafenib in patients with advanced hepatocellular carcinoma (primary liver cancer).

20 Jul 2010

Athletes who undergo tissue transplant surgery for knee damage can return to sports: Study

Athletes with bone and cartilage knee damage who are treated with transplanted tissue can return to sports after surgery, according to a Hospital for Special Surgery study reported at the annual meeting of the American Orthopaedic Society for Sports Medicine, held July 15-18 in Providence, Rhode Island. The study (abstract 8970) overturns the widely held belief that patients who undergo this surgery do not return to athletics.

20 Jul 2010