Astra Biotech GmbH is a new company whose core focus is the development of innovative diagnostics for the identification of an individual’s predisposition to disease. With this in mind, Astra Biotech GmbH has produced a portfolio of assays in areas such as genetically associated disorders, hormonal dysfunctions including fertility tests, allergies, and others.
Key targets so far are for osteoporosis, a condition which affects over 75 million people worldwide and thrombosis, a major fatal disease in developed countries.
Other diagnostic kits include one for the determination of an individual’s susceptibility or resistance to oral anticoagulants, predisposition to mental diseases as well as niche and infectious diseases.
The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces positive pre-clinical results from its in-house product candidate C3BS-GQR-1, a “cardiopoietic” cocktail designed to treat patients suffering from acute myocardial infarction in order to protect cardiac tissue from damage and direct heart stem cells to mature and restore pump function. This therapeutic candidate diversifies the product portfolio of Cardio3 BioSciences offering regeneration without the need for stem cell injection. This newest innovation builds on an ongoing collaboration with Mayo Clinic investigators.
C3BS-GQR-1 aims to effectively treat acute myocardial infarction (heart attack) by protecting heart tissues at the time of injury, and by promoting activation of resident progenitor cells. C3BS-GQR-1 greatly increases the potential of self-repair exploiting thereby the intrinsic regenerative capacity of the heart itself.
Soya protein’s ability to lower total and LDL (“the bad”) cholesterol has been extensively studied, but the mechanism whereby soya protein lowers cholesterol remains unresolved.
A new study published in the Journal of Clinical Lipidology showed that soya protein lowered total cholesterol and non-HDL cholesterol significantly more than milk protein in patients with moderately high cholesterol levels.
“Non-HDL cholesterol has been shown to be a somewhat stronger predictor of cardiovascular disease and mortality risk than LDL cholesterol in population studies,” said Dr. Elaine Krul, co-author of the study and nutrition discovery lead at Solae. “The fact that soya protein significantly decreased non-HDL cholesterol levels compared to milk protein in this study is very promising.”
MorphoSys AG announced today that it has received a clinical milestone payment from Centocor Ortho Biotech Inc in connection with the regulatory filing of a clinical trial application for a phase 1 clinical trial of a HuCAL-derived antibody in the therapeutic area of inflammatory and autoimmune diseases. Today's news marks the seventh clinical milestone for MorphoSys in 2010.
"The seventh clinical milestone with partners in 2010 surpasses our original expectations for the year of up to six such events," commented Dr Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Today's news marks another milestone for the HuCAL platform, clearly illustrating the success of this technology."
MorphoSys's clinical pipeline now comprises nine partnered programs in Phase 1 and five in Phase 2 development as well as the Company's proprietary programs MOR103, which is in a Phase 1b/2a trial for rheumatoid arthritis, and MOR208, which is in a Phase 1 trial for chronic lymphocytic leukemia.
Oxford BioMedica plc, a gene therapy company, announces new data from the on-going Phase I/II trial of ProSavin for the treatment of Parkinson’s disease (PD).
Three-month data from the third patient cohort show that ProSavin continues to be safe and well-tolerated following treatment with a 2x dose using an enhanced administration technique developed by the Company. The enhanced technique has been shown to reduce the surgical delivery time, will facilitate higher dosing and has the potential to provide better reproducibility of administration as study centres expand.
By way of background, the current Phase I/II study is designed to assess the safety, efficacy and dose evaluation of ProSavin in patients with mid-stage PD who are experiencing reduced benefit on L-DOPA “equivalent” therapy. To date, nine patients have been treated in cohorts of three.
Porvair Filtration Group, a leader in filtration and separation technology, has announced the publication of a new brochure that details the specialist capabilities of its growing family of BioVyon sintered porous plastics.
The BioVyon range of sintered porous polypropylene and polyethylene materials has been developed to offer optimum product solutions. Manufactured in ISO-accredited cleanrooms, BioVyon materials exhibit very low particle shedding, low extractables and low bio burden.
Manufactured to current good manufacturing practices (cGMP), the BioVyon materials are made to demanding regulatory standards as required by the WRAS, FDA and USP.
ERT, a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, today confirmed that the effective date of the previously announced retirement of Dr Michael J McKelvey, its President and CEO, is December 21, 2010.
Dr Joel Morganroth (pictured), currently ERT's Chairman and Chief Scientific Officer, has also been elected by the Board as President and CEO until ERT hires a permanent CEO. Dr Morganroth has served as the Chairman of ERT's Board of Directors since 1999 and as Chief Scientific Officer since April 2006. He previously served as the company's Chief Executive Officer from 1993 to March 2001 and also has consulted for ERT since 1977. Dr Morganroth is also a globally recognized cardiologist and clinical researcher and has had more than 10 years' experience as a medical review officer/expert for the US Food and Drug Administration (FDA).
Dr Morganroth commented: "We thank Dr McKelvey for his years of service and wish him well in his future endeavors."
British scientists are using smart phone location tracking technology to predict the spread of infectious diseases. This will provide important clues about how quickly a pandemic might occur.
Technology specialists at Edinburgh Napier University are working with Imperial College London on the use of 'geo' - information available from location tracking devices - to record the nature and frequency of interactions between individuals to understand how infections spread.
With location-tracking technology in handheld devices such as smart phones it is now possible to track the path of an infected person and their contacts with one metre accuracy.
AMSBIO is now able to offer a range of over 4,000 full length affinity purified human proteins expressed in HEK293 cells and derived using an extensive collection of human cDNA clones.
The new range is currently the broadest offering of human proteins produced in human cells. It has been prepared to ensure optimal preservation of protein structure, post-translational modifications and functions.
All AMSBIO full length proteins come affinity purified and are guaranteed to be greater than 80% pure making them ideal for use as native antigens for optimized antibody production; positive controls in antibody assays; ELISA assay standards ; Protein-protein interaction experiments; in vitro biochemical assays; cell-based functional assays and SRM/MRM standards.
All the human proteins in the new range are available in small trial size quantities and AMSBIO provides fast development of larger (mg) quantities. In addition to these standard products AMSBIO also offers a custom protein expression and purification service tailored to your specific needs, including protein domains, different expression tags and expression host.
Fluidigm has launched a new comprehensively featured website (www.fluidigm.com) designed to offer a wide variety of useful information to life science organisations involved with gene expression, single cell research, SNP genotyping, target resequencing, NGS sample preparation and determination of copy number variation.
Intuitively designed the website provides ready access to detailed technical information relating to Fluidigm's state-of-the-art range of Integrated Fluidic Circuit (IFC) systems, chips, kits and assays. The visitor experience is further enriched through access to detailed information relating to the company's proprietary technologies, product video demonstrations, a large database of informative application notes, articles and posters, customer success stories and a 2011 program of events.
Easy access is provided on site to Fluidigm technical support group as well as listing contact details for local support outlets in North America, Asia and Europe. The site also provides a company overview that details the series of technological innovations overthe last decade that have made Fluidigm a technological leader in life science research.
Fluidigm develops, manufactures and markets proprietary Integrated Fluidic Circuit (IFC) systems that significantly improve productivity in life science research. Fluidigm IFCs enable the simultaneous performance of thousands of sophisticated biochemical measurements in extremely minute volumes. These "integrated circuits for biology" are made possible by miniaturizing and integrating liquid handling components on a single microfluidic device. Fluidigm systems, consisting of instrumentation, software and chips, increase throughput, decrease costs and enhance sensitivity compared to conventional laboratory systems.
Thermo Fisher Scientific today announced that Colin Booth, director regulatory affairs – microbiology (Oxoid and Remel brands), will speak at the forthcoming European Diagnostic Performance Evaluation & Regulatory Conference, to be held in Brussels, Belgium January 24-25, 2011.
The conference theme is “Understanding and Appreciating the Evolving Regulatory Path for Diagnostic Tests and the Clinical Challenges in Sample Size and Design to Support European Regulatory Approvals.”
Thermo Fisher Scientific Inc today announced that it has completed the acquisition of TKA Wasseraufbereitungssysteme GmbH, a European provider of laboratory water purification systems. Based in Niederelbert, Germany, TKA has nearly 60 employees and had 2009 full year revenue of approximately €10 million.
“The addition of TKA’s comprehensive offering of laboratory water purification systems to our portfolio of laboratory equipment and consumables enables us to meet our customers’ growing needs for versatility and productivity in their laboratories,” said Thomas Loewald, president laboratory equipment of Thermo Fisher Scientific. “The demand for ultrapure water, in particular, is driven by the ever-increasing sensitivity of analytical instruments used in life science research.”
CEVEC Pharmaceuticals, the developer of the CAP protein expression system derived from human amniocytes, today announced that Rainer Christine has joined its supervisory board.
Rainer Christine was the CEO and co-founder of the German-American biotools company amaxa and plays an active role in the life sciences related venture capital industry. Under Rainer’s leadership amaxa grew from start-up in 1998 to a full-fledged and profitable life science company with strong scientific and commercial activities, 160 staff in Europe and the US, and more than EUR 100 million in cumulative sales. In 2008, amaxa was successfully sold to Lonza, a global supplier to the life-science industry.
Biogen Idec and Neurimmune Holding AG today announced that Biogen Idec has acquired a subsidiary of Neurimmune, which includes the worldwide rights to three pre-clinical immunotherapy programmes.
The three programs are focused on the discovery and development of novel human antibodies that address three central nervous system (CNS)targets: alpha-synuclein, tau and TDP-43. These targets are believed to be relevant for the treatment and prevention of a wide variety of neurodegenerative diseases, including Parkinson’s disease, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS). Biogen Idec will make an initial payment of $32.5 million and up to $395 million in contingent payments.
Proximagen Group plc , the company with a principal focus on the treatment of disorders of the central nervous system (CNS), has announced that it has signed an exclusive agreement with GlaxoSmithKline (GSK) to acquire the global rights to two drug development programmes.
Both programmes target diseases of the CNS; the more advanced program is ready to enter the clinic to be investigated for its potential to treat cognition disorders.
Proximagen is acquiring these assets following the announcement by GSK in February that it would be stopping drug discovery efforts in some areas of neurosciences including psychiatry and pain.
PharmaNet Development Group Inc, a provider of drug development services to the pharmaceutical, biotechnology, generic drug and medical device industries, has announced that its regulatory and pharmaceutical development experts are available to offer guidance on the regulatory pathway for biosimilar development in the United States, following a recent Food and Drug Administration (FDA) hearing. The two day public hearing aimed to obtain input from interested stakeholders on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
PharmaNet recently attended the two day FDA hearing. While the FDA hearing highlighted the diverse approaches and opinions presented by different industry participants, PharmaNet in-house experts, including some former senior level officials from the FDA, are available to offer insight into industry and regulatory perspectives. As an industry leading CRO with experience in clinical development and regulatory issues of branded innovator biologics and generic drugs, the company is available to provide advice to industry members developing biosimilars.
Simplifying PCR – or Polymerase Chain Reaction, a biotechnology technique used to replicate a specific portion of a much larger sample of DNA - and the related instrumentation could enable advances in both clinical and basic research as well as expand the number of places where molecular biology diagnostic testing could be performed.
Reporting in the January 2011 issue of BioTechniques, researchers from the National Taiwan University in Taipei describe their development of a new PCR system that requires only a capillary tube and a single isothermal heating unit.
SEEK, a leading UK privately-owned drug-discovery group, is pleased to announce the establishment of a new joint venture entity with Pernix Therapeutics Holdings Inc, an integrated specialty pharmaceutical company focused primarily on the United States pediatric market. The joint venture will undertake the late-stage development and registration of BC1036, a first-in-class antitussive drug, to address the serious need for an effective, safe, non-opioid treatment for persistent cough. Both parties will also contribute all of their theobromine intellectual property by way of licence or assignment into the joint venture.
Following consultation with a European regulatory authority, the new venture will conduct a single pivotal Phase III trial of BC1036, which is expected to begin in the first half of 2011. This truncated regulatory path is due to the significant historical safety data available for theobromine and the beneficial effect seen in human use to date. The new venture is also in discussions with the US regulatory authorities and expects to be able to confirm the regulatory programme in the US early next year.
An advanced type of magnetic resonance imaging (MRI) could be used instead of an invasive biopsy to decide whether prostate cancer patients under Active Surveillance need treatment. The results of a pilot study to investigate the technique are published online today in The British Journal of Radiology.
Some prostate cancers can be aggressive while others never require treatment. Men diagnosed with early stage prostate cancer therefore have the option of delaying therapy and opting instead for Active Surveillance - regular monitoring by biopsy and testing levels of prostate specific antigen (PSA) in the blood. However, biopsies are invasive and carry side-effects while PSA testing can be inaccurate, so scientists are looking for other ways to monitor cancer growth in these men and determine if treatment is needed.
Select Biosciences has announce that the agenda is online for the Stem Cells World Congress, which is taking place at the Holiday Inn on the Bay, San Diego, California, USA on Monday 24th and Tuesday 25th January 2011.
The keynotes speakers are:
Dennis Clegg, Professor, UCSB.
Lawrence Goldstein, Professor of Cellular and Molecular Medicine Howard Hughes Medical Institute, UCSD.
Jan Nolta, Director of the Stem Cell Program, UCD.