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FDA approves Berinert for treating HAE in adults and adolescents

Berinert®, a human C1 esterase inhibitor (C1-INH) for treating acute episodes of facial or abdominal hereditary angioedema (HAE) in adults and adolescents has obtained approval from the US Food and Drug Administration (FDA).

25 Nov 2009

Synexus recruits patients to study paediatric vaccine against rotavirus

UK-based Synexus, the world’s largest multi-national company dedicated to the recruitment and running of clinical trials, recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus.

From AES - Accelerated Enrollment Solutions 25 Nov 2009

Positive Phase II/III clinical data from ChemoCentryx' PROTECT-1 Traficet-EN trial

ChemoCentryx, Inc., announced today that Phase II/III clinical data from the Company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated clinical efficacy with a favorable safety and tolerability profile. The

25 Nov 2009

CHMP positive opinion for marketing ELONVA in Europe

PROLOR Biotech, Inc., today noted the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing approval in Europe for ELONVA(R), a long-acting CTP-modified version of the fertility hormone FSH from Merck & Co. Merck and PROLOR are both licensees of the CTP technology from Washington University in St. Louis.

25 Nov 2009

Pilot clinical study results of laser treatment for toenail fungus presented

PinPointe USA, Inc., a privately held emerging medical technology company which introduced the breakthrough PinPointe FootLaser treatment for toenail fungus in Europe, today announced that Dr. Brian McDowell presented the results of his pilot clinical study “Laser Treatment for Toenail Fungus” (Harris, McDowell and Strisower, Proc. SPIE 7161A, 2009) at the Society of Chiropodists and Podiatrists Annual Conference 2009 at Harrogate International Centre on November 19.

25 Nov 2009

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Ipsen today announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer.

25 Nov 2009

Positive efficacy data from Phase 2 study of AEZS-108 announced

AEterna Zentaris Inc. (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with advanced or recurrent endometrial cancer.

25 Nov 2009

Ohr Pharmaceutical to develop OHR/AVR118 for cachexia treatment

Ohr Pharmaceutical Inc. is developing OHR/AVR118 for treatment of cachexia based on technology acquired earlier this year from Advanced Viral Research Corp. OHR/AVR118 has shown excellent therapeutic efficacy and safety in human clinical trials in over 100 patients with applications for cachexia in Cancer and AIDS patients, as well as Rheumatoid Arthritis.

24 Nov 2009

CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.

24 Nov 2009

Fourth-quarter and full year fiscal 2009 results announced by AVANIR Pharmaceuticals

AVANIR Pharmaceuticals, Inc. today reported unaudited financial results for the three and twelve months ended September 30, 2009.

24 Nov 2009

Positive data from Æterna Zentaris' Phase 2 targeted cytotoxic peptide conjugate study

Æterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with advanced or recurrent endometrial cancer.

24 Nov 2009

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.

24 Nov 2009

StemCells commences patient recruitment for a Phase I clinical trial of HuCNS-SC in PMD

StemCells, Inc. announced today that it has commenced patient recruitment for a Phase I clinical trial designed to test the safety and preliminary efficacy of its HuCNS-SC® purified human neural stem cells in Pelizaeus-Merzbacher Disease (PMD), a neurological disorder that primarily afflicts children. The study is being conducted at the University of California, San Francisco (UCSF) Children’s Hospital, one of the leading medical centers in the United States for neonatology, pediatric neurology and neurosurgery.

24 Nov 2009

DSS sets evidence-based guidelines and definitions to treat type 2 diabetes

A first-of-its-kind consensus statement on diabetes surgery is published online today in the Annals of Surgery. The report illustrates the findings of the first international consensus conference -- Diabetes Surgery Summit (DSS) -- where an international group of more than 50 scientific and medical experts agreed on a set of evidence-based guidelines and definitions that are meant to guide the use and study of gastrointestinal surgery to treat type 2 diabetes. The document is considered to be the foundation of diabetes surgery as a medical discipline of its own.

24 Nov 2009

New data indicates early association between anti-inflammatory medication and cardiovascular risk

Clinical trial data indicated an association between the anti-inflammatory medication rofecoxib and cardiovascular risk as early as December 2000, before the product was taken off the market in September 2004, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

BioAlliance Pharma's AMEP biotherapy reduces both tumour growth and tumour angiogenesis

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, has presented preclinical results on its new biotherapy, AMEP™ for advanced and metastatic melanoma at the ESGCT (European Society of Gene and Cell Therapy) in Hannover (November 21 to 25, 2009).

24 Nov 2009

Scientists determine how insulin resistant drugs alter core biochemical pathways through systems biology approach

Researchers from the University of California, San Diego recently offered the sharpest-yet picture of how core biochemical pathways in skeletal muscle cells and fat cells are altered in people who suffer from insulin resistance-a primary defect in type 2 diabetes and obesity. Taking a systems biology approach, the bioengineers and medical researchers also determined how a common class of drugs for treating insulin resistance-TZDs-alter these same core pathways.

24 Nov 2009

Human-derived UCB stem cell transplant has positive therapeutic effects on specific lung and heart disorders

Two separate studies published in the current issue of Cell Transplantation (18:8), - now freely available on-line at http://www.ingentaconnect.com/content/cog/ct - have shown that transplanted human-derived umbilical cord blood (UCB) stem cells transplanted in an animal model had positive therapeutic effects on specific lung and heart disorders the animal models.

24 Nov 2009

AmKor and Hengdian Group sign license agreement to develop and market new drug candidate in China

AmKor (AmKor Pharma, Inc.) and Hengdian Group (Hengdian Group Ltd) today announced the signing of licensing agreement for further development and commercialization of Neu2000 in China.

24 Nov 2009

BioTrends Research Group releases Wave 2 report on AMAG's Feraheme

BioTrends Research Group, Inc. released Wave 2 of its LaunchTrends(TM): Feraheme report, the second in a multi-phase syndicated market research project tracking the launch of AMAG's new IV iron product, Feraheme, through the first six months of product availability. Each wave of the report provides quantitative information from 50 unique Nephrologists and qualitative information from a subset of 15.

23 Nov 2009

Efficacy News and Research

FDA approves Berinert for treating HAE in adults and adolescents

Synexus recruits patients to study paediatric vaccine against rotavirus

Positive Phase II/III clinical data from ChemoCentryx' PROTECT-1 Traficet-EN trial

CHMP positive opinion for marketing ELONVA in Europe

Pilot clinical study results of laser treatment for toenail fungus presented

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Positive efficacy data from Phase 2 study of AEZS-108 announced

Ohr Pharmaceutical to develop OHR/AVR118 for cachexia treatment

CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

Fourth-quarter and full year fiscal 2009 results announced by AVANIR Pharmaceuticals

Positive data from Æterna Zentaris' Phase 2 targeted cytotoxic peptide conjugate study

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

StemCells commences patient recruitment for a Phase I clinical trial of HuCNS-SC in PMD

DSS sets evidence-based guidelines and definitions to treat type 2 diabetes

New data indicates early association between anti-inflammatory medication and cardiovascular risk

BioAlliance Pharma's AMEP biotherapy reduces both tumour growth and tumour angiogenesis

Scientists determine how insulin resistant drugs alter core biochemical pathways through systems biology approach

Human-derived UCB stem cell transplant has positive therapeutic effects on specific lung and heart disorders

AmKor and Hengdian Group sign license agreement to develop and market new drug candidate in China

BioTrends Research Group releases Wave 2 report on AMAG's Feraheme

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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