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RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.

19 Jan 2011

Aastrom secures US patent for autologous cell therapy product

Aastrom Biosciences, a leading developer of expanded autologous cellular therapies for severe, chronic cardiovascular diseases, today announced that it has been granted a U.S. patent which provides composition of matter protection for its investigational expanded autologous cell therapy product.

19 Jan 2011

Boehringer Ingelheim to acquire Amgen's Fremont California development and manufacturing facility

Amgen Inc. and Boehringer Ingelheim today announced they have signed an agreement under which Boehringer Ingelheim will acquire Amgen's rights in and substantially all assets at Amgen's Fremont California development and manufacturing facility.

19 Jan 2011

iBio grants commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos for new yellow fever vaccine

iBio, Inc. today announced the grant of a commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos of Brazil to develop, manufacture and sell certain vaccines based upon iBio's proprietary technology. Fiocruz/Bio-Manguinhos will invest more than $6 million to bring the first product - a new yellow fever vaccine - through Phase I clinical trials.

18 Jan 2011

New data on role of miR-34 tumor suppressor in preventing cancer stem cell development

Mirna Therapeutics, Inc., a leading developer of microRNA (miRNA)-based therapeutics, announced today the publication of new data in the journal Nature Medicine describing the role of the tumor suppressor miRNA, miR-34, in preventing cancer stem cell development. The published results reveal that miR-34 is commonly down-regulated in prostate cancer stem cells and that this down-regulation is essential for cancer stem cell viability.

18 Jan 2011

NCI sponsors fourth REOLYSIN clinical trial in pancreatic cancer

Oncolytics Biotech Inc. announced today that the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, has agreed to sponsor a 2-Arm randomized Phase II study of carboplatin, paclitaxel plus REOLYSIN® versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer.

18 Jan 2011

Heart disease patients' skin cells may help test long QT syndrome

Skin cells from a patient with an inherited heart disease were the seeds of a stem cell experiment that could help researchers test specific treatments for the disease, known as long QT syndrome. The research results appear in the January 16 issue of the journal Nature.

18 Jan 2011

New magnetic pill system can serve as drug delivery tool in patients with cancer, diabetes

A new magnetic pill system developed by Brown University researchers could solve the problem by safely holding a pill in place in the intestine wherever it needs to be.

18 Jan 2011

Stem cell exhibition to broaden debate on the issue

The topic remains complex and controversial, the technology innovative and promising, and the debate, on stem-cell research, continues unabated. And now, the subject is receiving the attention of a group not normally associated with scientific discoveries. University of Alberta printmaking professor, Sean Caulfield, along with U of A Health Law Institute research director and researcher, Tim Caulfield, have brought together a group of visual artists from Europe and North America to contribute to the stem-cell debate that often pits politicians, scientists, pundits and religious leaders against each other.

17 Jan 2011

Advaxis receives DSMB approval to complete dosing in first leg of ADXS11-001 cervical dysplasia clinical trial

The science team from Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, met with the Data Safety Monitoring Board (DSMB), an independent group of medical experts, yesterday and received approval to dose all remaining patients in the initial forty (40) patient leg of the 120-patient, cervical dysplasia clinical trial being conducted in the United States.

14 Jan 2011

Simulations Plus first quarter consolidated revenues increase 15.4% to record $2.811M

Simulations Plus, Inc., a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its first quarter of fiscal year 2011 ended November 30, 2010 (1QFY11).

14 Jan 2011

ICON announces acquisition of Oxford Outcomes

ICON plc,, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the expansion of its Late Phase and Outcomes Research services through the acquisition of Oxford Outcomes, a leading international health outcomes consultancy.

14 Jan 2011

Vitrolife receives patent protection for Swemed Sense needle in European markets

Swemed Sense™ is a unique needle that is used for the collection of oocytes in connection with IVF. The approved patent means that Vitrolife has both design protection and product patent protection for Swemed Sense™ in strategically important European markets. A patent has also been applied for in other prioritized markets.

14 Jan 2011

ShangPharma opens new multi-purpose pharma development and cGMP manufacturing facility in Fengxian

ShangPharma Corporation, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced commencement of operations on the initial phase of production at the Company's Fengxian facility. This new multi-purpose pharmaceutical development and cGMP manufacturing facility is located in Fengxian in the suburbs of Shanghai, China.

14 Jan 2011

First Edition: January 13, 2011

Today's headlines feature reports about how House GOP leaders -- in the aftermath of last weekend's Tucson, Ariz., tradgedy -- are wrestling with how best to retool their health repeal effort and bring the measure forward for a vote.

13 Jan 2011

Kaneka, Atrium Medical introduce FDA-approved Xpress-Way RX Extraction Catheter

Atrium Medical Corporation and Kaneka Corporation are proud to announce the introduction of the Xpress-Way RX Extraction Catheter. Xpress-Way RX has recently received FDA 510K clearance and is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

13 Jan 2011

Therapeutic workshops selected for presentation at the Thirteenth Annual BIO CEO & Investor Conference

The Biotechnology Industry Organization (BIO) today announced the selection of therapeutic workshops to be presented at the Thirteenth Annual BIO CEO & Investor Conference, taking place February 14-15.

13 Jan 2011

BioCryst reports positive results from peramivir Phase 3 study in influenza

BioCryst Pharmaceuticals, Inc. today announced top-line results from one of its two Phase 3 studies of intravenous (i.v.) peramivir for the treatment of patients hospitalized with influenza, and provided an update regarding its peramivir program.

13 Jan 2011

SDIX receives FDA method equivalency and AOAC-RI certification for Salmonella Enteritidis test system

SDIX, a leading supplier of rapid detection solutions to the $1 billion food pathogen testing market, today announced that its RapidChek® SELECT™ Salmonella Enteritidis (SE) test system has been reviewed by the U.S. Food and Drug Administration (FDA) and determined to be equivalent in accuracy, precision and sensitivity to their current standard methods for poultry house environmental drag swabs and pooled egg testing.

13 Jan 2011

BP-lowering medications provide long-term benefit of reducing death risk from cardiovascular disease

In a study published in December 2010, in Hypertension, a journal of the American Heart Association, investigators have shown that early treatment with blood pressure-lowering medications provides a long-term benefit of reducing the risk of death from cardiovascular disease.

13 Jan 2011

Biotechnology News and Research

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Aastrom secures US patent for autologous cell therapy product

Boehringer Ingelheim to acquire Amgen's Fremont California development and manufacturing facility

iBio grants commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos for new yellow fever vaccine

New data on role of miR-34 tumor suppressor in preventing cancer stem cell development

NCI sponsors fourth REOLYSIN clinical trial in pancreatic cancer

Heart disease patients' skin cells may help test long QT syndrome

New magnetic pill system can serve as drug delivery tool in patients with cancer, diabetes

Stem cell exhibition to broaden debate on the issue

Advaxis receives DSMB approval to complete dosing in first leg of ADXS11-001 cervical dysplasia clinical trial

Simulations Plus first quarter consolidated revenues increase 15.4% to record $2.811M

ICON announces acquisition of Oxford Outcomes

Vitrolife receives patent protection for Swemed Sense needle in European markets

ShangPharma opens new multi-purpose pharma development and cGMP manufacturing facility in Fengxian

First Edition: January 13, 2011

Kaneka, Atrium Medical introduce FDA-approved Xpress-Way RX Extraction Catheter

Therapeutic workshops selected for presentation at the Thirteenth Annual BIO CEO & Investor Conference

BioCryst reports positive results from peramivir Phase 3 study in influenza

SDIX receives FDA method equivalency and AOAC-RI certification for Salmonella Enteritidis test system

BP-lowering medications provide long-term benefit of reducing death risk from cardiovascular disease

Industry Focus eBook - Biotechnology (4th edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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