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FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and

10 Jun 2010

Interim results from PROPEL study of RG7128 submitted as abstract to AASLD for Annual Liver Meeting

Pharmasset, Inc. announced today that the interim results from the PROPEL study conducted by its partner Roche demonstrate that RG7128 triple combination therapy was safe and well tolerated. In that study, the safety profile of RG7128 (1000mg BID or 500mg BID), when administered for 8 or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care, was similar to the safety profile of SOC alone.

9 Jun 2010

Purdue University researchers develop potential new tool for medical diagnostics, testing food

Researchers at Purdue University have developed a potential new tool for medical diagnostics, testing food and water for contamination, and crime-scene forensics.

9 Jun 2010

Quintiles announces comprehensive suite of PI3K biomarker assays

Quintiles today announced a comprehensive suite of biomarker assays to help biopharmaceutical companies investigate the phosphoinositide 3-kinases (PI3K) cancer survival pathway, the focus of numerous anti-cancer therapies under development. Understanding the PI3K pathway is essential in developing new medicines to inhibit or block this pathway, thereby cutting off a metabolic function needed for certain cancers to survive.

8 Jun 2010

Celera applies CE mark to real-time PCR test for detection of variant in KIF6 gene

Celera Corporation today announced that it has signed a Declaration of Conformity and applied the CE mark to a real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the European Union and other geographic areas that recognize the CE Mark.

7 Jun 2010

Merck launches Oncology Collaborative Trials Network

Today, Merck announced the launch of the Merck Oncology Collaborative Trials Network, a pioneering clinical trial network focusing on the development of Merck drug and vaccine candidates being investigated for the treatment and prevention of cancer. The global network comprises leading cancer research centers who will partner with Merck to speed the development of innovative treatments for a range of cancers.

4 Jun 2010

BD Diagnostics receives 510(k) clearance to market GBS assay on BD MAX System

BD Diagnostics, a segment of BD, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the BD MAX™ GBS Assay for Group B Streptococcus on the BD MAX System. The BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility.

From BD (Becton, Dickinson and Company) 3 Jun 2010

Alnylam, Mount Sinai scientists discover svRNAs that play a critical role in influenza A virus replication

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the publication of new research findings in the journal Proceedings of the National Academy of Sciences (PNAS) by Alnylam scientists and collaborators from Mount Sinai School of Medicine. In the new study, Alnylam and Mount Sinai scientists discovered a novel class of virus-produced small non-coding RNAs, called small viral RNAs (svRNAs), which play a critical role in the replication of influenza A virus.

2 Jun 2010

Thermo Fisher Scientific to acquire Fermentas International for $260M

Thermo Fisher Scientific Inc., the world leader in serving science, announced today that it has signed a definitive agreement to acquire Fermentas International Inc. - a manufacturer and global distributor of enzymes, reagents and kits for molecular and cellular biology research - for $260 million in cash, subject to a post-closing adjustment. With headquarters in Burlington, Ontario, and principal operations in Vilnius, Lithuania, Fermentas has approximately 500 employees.

From Thermo Fisher Scientific Inc. 28 May 2010

ifp Institut für Produktqualität sells molecular biological, PCR-based food test product line to QIAGEN

The Berlin-based diagnostics company ifp Institut für Produktqualität has sold its molecular biological, PCR-based food test product line to QIAGEN at a price not revealed. QIAGEN has purchased all the required patents and licences and will immediately begin to market and distribute the newly acquired portfolio of 70 molecular biological tests. With the support of this powerful and experienced partner in food diagnostics ifp can now make available its expertise in food analytics globally.

From QIAGEN Manchester Limited 26 May 2010

QIAGEN acquires rights to 70 molecular food safety tests developed by Institute for Product Quality

QIAGEN today announced that it has entered into an agreement with the Institute for Product Quality (ifp), pursuant to which QIAGEN has acquired all rights to 70 molecular food safety tests developed by the Berlin-based specialized laboratory center for food analysis.

From QIAGEN Manchester Limited 26 May 2010

FDA issues 510(k) clearance to Simplexa Influenza A H1N1 (2009) test on 3M Integrated Cycler

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration has issued 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

25 May 2010

Health Canada grants Response Biomedical Class 3 Medical Device license for RAMP RSV Assay

Response Biomedical Corporation today announced that it has been granted a Class 3 (near patient/point-of-care) Medical Device license by Health Canada to market its RAMP® Respiratory Syncytial Virus (RSV) Assay in Canada.

18 May 2010

Inhibitex reports net loss of $4.8M for first-quarter 2010

Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.

14 May 2010

UGA researchers discover SERS method to identify rotavirus strains, genotypes

Using nanotechnology and a patented signal enhancing technique developed at the University of Georgia, UGA researchers have discovered a rapid, sensitive and cost-effective method to detect and identify a number of rotavirus strains and genotypes in less than one minute with greater than 96 percent accuracy.

14 May 2010

Roche launches cobas(R) 4800 System in Canada for testing CT, NG and HPV

Roche Diagnostics Canada announced today the launch of a new Health Canada approved clinical laboratory system designed to increase laboratory testing efficiency and to accommodate current and long-term molecular diagnostic needs. The cobas(R) 4800 System combines in vitro diagnostic tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and human papillomavirus (HPV) testing with fully-automated sample preparation and real-time polymerase chain reaction (PCR) technology.

From Roche Sequencing and Life Science 7 May 2010

Latest LLMDA technology available to detect viruses, bacteria

Law enforcement authorities seeking to detect bioterrorism attacks, doctors diagnosing diseases and regulatory agencies checking product safety may find a new ally in a Lawrence Livermore National Laboratory detection technology.

6 May 2010

Genomic Health reports 22% revenue growth, 58% decrease in net loss for first-quarter 2010

Genomic Health, Inc. today reported financial results and business progress for the quarter ended March 31, 2010.

6 May 2010

Iowa State University researcher works on faster method to detect salmonella from contaminated foods

Using technology available through a local company, an Iowa State University researcher is working on a faster method to detect and genetically identify salmonella from contaminated foods.

5 May 2010

Study finds standard heel-stick test ineffective in identifying CMV infection in babies

A national study involving a UT Southwestern Medical Center neonatologist and pediatric infectious diseases specialist suggests that a screening test routinely performed in newborns is not very good at identifying cytomegalovirus (CMV) infection, a leading cause of hearing loss in children.

4 May 2010