Dr. Kornelia Berghof-Jaeger, CEO, BIOTECON Diagnostics: ”In this alliance Merck KGaA will contribute significantly through its expertise in microbiology and its excellent customer relationships. Jointly we are able to fulfill the customer needs by introducing this new technology to the food safety testing labs around the world.”

“For Merck KGaA this partnership means a consequential advancement in order to underline our leading position in specialty chemicals, especially in analytical reagents and test kits” comments Wolfgang E. Schmidt, Head of Microbiology, Hygiene and Microscopy at Merck KGaA. “Our philosophy of highest quality demands is perfectly met by the solutions offered by BIOTECON Diagnostics.”

The increasing use of rapid food safety testing is receiving more and more attention. The major reason for this key trend is that the food industry requires quick and accurate results. Traditional microbiological methods are relatively slow and sometimes inaccurate in comparison to innovative molecular biological techniques. Fast and reliable detection systems are therefore the method of choice. In particular, advanced real time PCR technology is increasingly being used in the rapid detection of food pathogens and spoilage microorganisms. PCR stands for polymerase chain reaction, a technique that allows an exponential amplification of DNA from just a few to more than a billion copies in less than one hour. This enables a significant reduction in the time taken to achieve results in comparison with conventional cultivation techniques.
After a simple sample preparation – just a small amount of bacteria is needed - the PCR testing can be easily performed in one hour, thereby effectively reducing costs, i.e. time and labor: As a result, the finished goods can be released several days earlier.

Under its foodproof® brand BIOTECON Diagnostics has developed real-time PCR detection kits for Enterobacteriaceae plus E. sakazakii (new), Salmonella, Listeria, Campylobacter, E. coli O157 etc. The range also comprises a unique kit for the screening of beer spoilage organisms as well as GMO testing kits.

BIOTECON Diagnostics GmbH with its headquarter in Potsdam / Berlin (Germany) has been a competent partner for molecular biological and microbiological issues for more than ten years. The focus is the development, production and marketing of PCR-based rapid detection systems. BIOTECON Diagnostics offers solutions for the food and beverages industry as well as for pharmaceutical and cosmetics manufacturers.

Merck KGaA is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 30,968 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

The nexttec™ DNA isolation system, for which nexttec GmbH holds a worldwide patent, allows purifying DNA with a single centrifugation step within four minutes following cell lysis. It is up to five times faster than currently used DNA isolation systems. This is possible through a proprietary sorbent matrix, which retains inhibiting substances, such as proteins and low molecular weight substances and lets pass the pure DNA. Current silica-based methods work the other way round by retaining the DNA and thus making washing steps necessary.

“The ready-to-use kits are very useful for downstream applications such as PCR, RT-PCR, sequencing and Southern Blots,” says Uwe Scheiwen from Bio&Sell.

DNA purification can be performed either with nexttec™ Clean Columns or nexttec ™ Clean Plates 96 for high throughput to get pure DNA from a wide range of sample materials such as tissue, cells, plants, blood, plasmid DNA, and genomic DNA. Also, special protocols for mousetail, zebra fish, bacteria in milk, mucosa smear test, sperm, or hair are available. The system ensures a high DNA recovery rate and reduces waste through avoiding unnecessary pipetting and washing steps. No hazardous chemicals are used. (b3c newswire )

“We are pleased to receive this FDA approval for Clarithromycin for Oral Suspension, an anti-infective agent that will add depth and breadth to our product line of anti-infectives that also includes Clarithromycin tablets. RPI will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place. This approval further expands our product portfolio of affordable generic alternatives and will be shipped immediately to all classes of trade,” according to Jim Meehan, Vice President of Sales and Distribution for RPI.

The Office of Generic Drugs, U.S. FDA, determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Biaxin® Granules (Clarithromycin for Oral Suspension, USP), 125 mg/5 mL and 250 mg/5 mL of Abbott Laboratories. Clarithromycin for oral suspension, USP, is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in a number of conditions including: Pharyngitis/Tonsillitis, Community-Acquired Pneumonia, uncomplicated skin and skin structure infections and disseminated mycobacterial infections.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies”, resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

Solvay has selected the Bionas® 2500 analyzing system because it allows monitoring of both acute (short-term) and chronic (long-term) effects of drug candidates in different cell types thanks to a proprietary perfusion system. Besides the long-term observation of cells under close to in vivo conditions, the observation of regeneration effects is also possible.

“The Bionas instrument is a valuable tool for compound ranking and helps us select the most promising compounds for further development,” says Dr. Michael Firnges at Solvay Pharmaceuticals GmbH.

The Bionas® 2500 analyzing system is a bench-top instrument that allows the simultaneous, label-free and high-content analysis of three metabolic parameters, such as acidification, oxygen consumption and adhesion of living cells. The Bionas instrument has been also selected by Solvay Pharmaceuticals Research Laboratories (Weesp, Netherlands) for target validation studies.(b3c newswire)

The Progeniq BioBoost provides hardware accelerated processing for the most computationally intensive applications in Bioinformatics – NCBI BLAST, Smith Waterman, HMMer and ClustalW. Processing these protein searches will be cut from months to days, and weeks to hours and minutes.

“The life sciences offer one of the best opportunities for information technology to accelerate the pace of drug discovery and development,” said Rudy Potenzone, Bio IT Alliance Manager at Microsoft. “Progeniq’s collaboration in the Alliance will be a tremendous boost in Bioinformatics data-processing and discoveries in the life science industry.”

By utilizing Field Programmable Gate Array (FPGA) technology, the processor is able to ‘rewire’ itself on the fly according to the application that needs to be accelerated. This results in further energy savings, as the FPGA consumes as little as 5 watts of power from the USB, as compared to the racks of servers and cooling required that it replaces.

“Progeniq is delighted to collaborate with Microsoft and Life Science companies in the Bio IT Alliance,” said Darran Nathan, Progeniq’s Chief Executive Officer. “We are confident that more users will benefit from the speedups from the BioBoost, and more in the life science industry can enjoy its benefits.”

The BioBoost Accelerated suite for Bioinformatics is available for immediate shipment at USD3,000 for first time buyers. Visit http://www.progeniq.com/products/offer.htm for details.

The Congress will take place between the 18th and 20th of October in the Leipzig Congress Center. The Congress is organized by the Fraunhofer Institute for Cell Therapy and Immunology. Furthermore the World Congress is accompanied by an extensive industrial trade fair, which makes direct communication possible between representatives from science and industry.

One special highlight of the 3rd World Congress of Regenerative Medicine takes place on October, 20. The Translational Centre for Regenerative Medicine (TRM) will hold a session with the title “Space Medicine meets Regenerative Medicine”. Important health professionals, biotechnologists and engineers from across Germany and Europe will discuss bioreactor technology, cell functions and tissue engineering under micro gravitation conditions, as well as explore radiobiology and life support systems.

The press conference will take place on 18th of October (11 a.m., Room 11, Congress Center Leipzig)

Further information regarding the Congress can be found under: www.regmed.org.(b3c newswire)

Standard therapy for cat fibrosarcoma is surgical removal. However, the tumor recurs in 75% of the patients within one year. The IMAGNA team has used Magnetofection to guide cytokine genes directly into the tumor prior to surgical excision. The idea was that the cytokine expression within the tumor mass might activate the immune system against the tumor so that tumor cells missed by the surgical procedure would be killed.

Preliminary results indicate that anti cancer immune therapy with Magnetofection reduces the relapse of cat fibrosarcoma from 75% to nearly 40%. Additional studies are intended to confirm and extend these promising preliminary results and to take initial steps towards a future drug approval, firstly for the veterinary medicine.

The partners contribute with their different competences in the field of veterinary medicine, therapeutic anti cancer vaccination, DNA production, gene transfer and targeting, pharmaceutical manufacturing and regulation.( b3c newswire)

Drug therapy management (DTM) is a distinct service or group of services that optimize therapeutic outcomes for individual consumers as a result of appropriate drug therapy. While it is often offered by organizations offering broader prescription benefit management services, it is a specialty service and can be offered by care management organizations as well.

URAC, the Washington, D.C.-based independent accreditor of health care management organizations, announced today the availability of its Drug Therapy Management Accreditation program for the commercial market. The announcement is the culmination of more than a year of standards development and testing associated with the concurrent development of its Prescription Benefit Management Accreditation program. The development process engaged all major stakeholder groups, including providers, health care organizations, insurers, and consumers as well as a field team of expert reviewers in the standards development and standards review process.

URAC’s DTM Accreditation standards are designed to help organizations drive appropriate therapeutic outcomes for consumers with a clear focus on patient safety, outcomes measurement and quality improvement. They address a broad range of functions, such as development of clinical policies using evidence-based medicine; patient communication regarding medication use; and promoting consumer rights, shared decision making and education.

“DTM is an emerging technique, and the standards provide a roadmap of what appropriate design and operations of a DTM program should be,” said Alan P. Spielman, URAC’s president and chief executive officer. “Establishing a DTM Accreditation distinct from our Pharmacy Benefit Management Accreditation program will allow us to ensure quality not only among pharmacy benefit management organizations that offer this service, but extend the reach to case management, disease management and pharmacy organizations which are interested in exploring more sophisticated ways to manage medication and incorporate DTM into their care management programs.”

For 60 years, MAF (http://www.morrisanimalfoundation.org/) has been at the forefront of research to treat and cure terrible diseases and health issues that afflict the animals we love: dogs, cats, horses and wildlife. MAF has in progress a global effort to cure canine cancer, the leading cause of death in dogs over the age of two. MAF research has been the catalyst for many animal health breakthroughs, and virtually every veterinarian on earth has been positively affected by MAF’s research and educational programs.

Recently Pfizer Inc. and the FDA announced the approval of Selzentry(TM) (Maraviroc), the first in a novel class of anti-retroviral drugs based on blocking the CCR5 co-receptor of HIV. Selzentry, in combination with other antiretroviral agents, is indicated for treatment-experienced adult HIV patients with only CCR5-tropic HIV-1 detectable who have evidence of viral replication, and HIV-1 strains resistant to multiple anti-retroviral agents. The FDA label states that when initiating therapy, tropism testing and treatment history should guide the use of Selzentry.

“Pathway is pleased to introduce this second generation diagnostic HIV tropism assay nationwide, providing clinicians a fast, sensitive and economical testing alternative to the currently available biological HIV tropism assay,” said Walter Narajowski, Pathway Diagnostics President and CEO. “This timely introduction of SensiTrop is a perfect example of Pathway’s strategy to license proprietary biomarkers, develop them, and rapidly commercialize them with diagnostic partners.”

SensiTrop(TM) is a molecular based assay designed and demonstrated to be highly-sensitive in detecting CXCR4-tropic HIV in patient samples that contain as little as 1% CXCR4. “The combination of SensiTrop’s high-sensitivity and rapid turn-around-time (less than 7 days) will be extremely valuable to HIV physicians and patients when utilizing co-receptor tropism status to guide the use of Selzentry,” said Terry Robins Ph.D., Vice President of Research and Development at Pathway Diagnostics.