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PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that its RenalGuard System(TM) will be utilized as part of a live case transmission from the Clinica Mediterranea, Naples, Italy, to the 30th Congresso Nazionale della Societa' Italiana di Cardiologia Invasiva (GISE) during the conference.

19 Oct 2009

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Ardea Biosciences, Inc. announced additional positive results from the completed first cohort of an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout.

19 Oct 2009

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).

19 Oct 2009

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

XenoPort, Inc. announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

19 Oct 2009

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received the approval by Health Canada for its pivotal Phase III clinical trial SAPPHIRE in patients with recurrent or refractory anaplastic astrocytoma.

19 Oct 2009

Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Emisphere Technologies, Inc. announced study results in which twice-daily oral salmon calcitonin using Emisphere’s proprietary Eligen® Drug Delivery Technology significantly suppressed markers of cartilage and bone degradation versus placebo in men and women with osteoarthritis, the most common form of arthritis.

19 Oct 2009

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem, Inc. a clinical-stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases, announced today that its lead drug candidate, ANG1005, has demonstrated a favorable safety and efficacy profile in more than 100 patients with brain cancer from two separate Phase 1 /2 clinical studies in patients with progressive gliomas, including recurrent glioblastoma, and in patients with progressive brain metastases.

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

19 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC® (febuxostat) treatment.

19 Oct 2009

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

Ethics in biomedical research: One-year grant from NIH to develop interactive educational software

Arkitek Studios and the Northwest Association for Biomedical Research (NWABR) have been awarded a $100,000 Phase I Small Business Innovation Research (SBIR) grant from the National Center for Research Resources, a component of the National Institutes of Health. This one-year grant, entitled ETHOS (Ethics Training Health Oriented Software), provides funding for development of interactive educational software that will underscore the critical role ethics plays in biomedical research.

19 Oct 2009

DKC establishes link between genetic mutation affecting telomerase function and human disease

The human genetic disease dyskeratosis congenita (DKC) is an autosomal dominant disease that leads to abnormalities in tissues with a rapid cell turnover - the skin, nails, bone marrow, lungs and gut. Patients with DKC experience life-threatening symptoms. Bone marrow failure increases their risk of fatal infections and cancer. Many die before the age of 30 and management of the disease is limited to trying to treat its symptoms.

19 Oct 2009

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Cardium Therapeutics today announced the publication of positive findings from the open label multi-center Phase 1/2 clinical study of Excellarate(TM) (GAM501, Ad5PDGF-B / 2.6% collagen), its product candidate for the potential treatment of non-healing diabetic foot ulcers.

19 Oct 2009

Mallinckrodt TaperGuard and TaperGuard Evac endotracheal tubes launched by Covidien

Covidien, a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, today announced the global launch of Mallinckrodt™ TaperGuard™ and TaperGuard™ Evac endotracheal tubes.

19 Oct 2009

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Biogen Idec and Biovitrum AB (STO: BVT) today announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients.

19 Oct 2009

PHARMACIA & UPJOHN COMPANY to pay the largest criminal fine ever imposed in the U.S.

PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. ("Pfizer") today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead.

19 Oct 2009

Innovative tool for providing patient-centered care for diabetics

Mayo Clinic clinicians and designers, along with colleagues from other institutions, have developed and tested a tool to involve patients more in their diabetes treatment and medication choices.

19 Oct 2009

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

19 Oct 2009

HealthScape Consumer to analyze patient and consumer data

Healthy Advice Networks, the nation's leading provider of physician office-based patient-education programs, announces a groundbreaking measurement program to track consumer purchase behavior, not just purchase intent, for OTC and consumer health brands.

19 Oct 2009

Efficacy News and Research

PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Rituxan's sBLA receives a Complete Response from the FDA

Ethics in biomedical research: One-year grant from NIH to develop interactive educational software

DKC establishes link between genetic mutation affecting telomerase function and human disease

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Mallinckrodt TaperGuard and TaperGuard Evac endotracheal tubes launched by Covidien

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

PHARMACIA & UPJOHN COMPANY to pay the largest criminal fine ever imposed in the U.S.

Innovative tool for providing patient-centered care for diabetics

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

HealthScape Consumer to analyze patient and consumer data

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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