BIOTECHNOLOGY and PHARMA NEWS 2012

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28.02.2012 MorphoSys Signs Three-Year Protein Engineering Alliance on Slonomics Technology    
MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced the signing of a protein engineering agreement with a large bio-pharmaceutical company. The non-exclusive license agreement covers the delivery of multiple Slonomics®-based DNA libraries. The libraries will encode a broad range of protein classes, excluding antibodies, and will be used by its partner for drug discovery.  
   
     
   
23.02.2012 iSOFT partners with Southampton on groundbreaking life science project    
iSOFT, a CSC company, and University Hospital Southampton NHS Foundation Trust are to jointly explore using new software to extract and anonymise clinical information for research and clinical trials, in one of the first projects of its type in the UK.  
   
     
   
New BRCA1-Associated Breast Cancer Susceptibility Gene Identified    
 

Scientists have discovered a mutation in a gene that interacts with BRCA1 in a significant number of familial breast cancer cases studied. The Abraxas protein links BRCA1 to a protein complex involved in BRCA1-dependent DNA damage responses.


 
 
     
   
 22.02.2012 Dyax Corp. Announces Fourth Quarter and Full Year 2011 Financial Results    
Dyax Corp. (NASDAQ: DYAX) today announced financial results for the fourth quarter and year ended December 31, 2011. Dyax will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and updates regarding its two key value drivers - the angioedema franchise and the Licensing and Funded Research Program (LFRP).    
   
     
   
22.02.2012 apceth and Indivumed to Develop Biomarker Platform for Targeted Cellular Therapies    
apceth GmbH & Co. KG, located in Munich, Germany, and Indivumed GmbH, based in Hamburg, Germany, have entered into a partnership for the development of a predominantly tissue-based biomarker strategy for the treatment of solid cancers with cellular and / or gene therapeutics.  
   
     
   
21.02.2012 MOLOGEN AG also wins patent protection in Japan for cell-based cancer therapy MGN1601    
The Japan Patent Office (JPO) has announced its decision to grant a patent to the biotechnology company MOLOGEN AG for its invention of an "allogeneic tumor therapy". This cancer therapy is based on allogeneic, genetically modified cancer cells and can be used to treat various types of cancer.  
   
     
$1000 genome might be just around the corner    
 

A new genome sequencing technology demonstrated by Oxford Nanopore could see an entire genome sequenced in under an hour by 2013. Oxford Nanopore has shaken up the genome sequencing world by demonstrating a new technology based on its nanopore technology that could deliver a $1000 genome in under an hour by 2013.


 
 
     
   
21.02.2012 ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution    
ELC Group, the pan-European pharmaceutical regulatory affairs organisation, today announces the launch of a new subsidiary, Pharma eReport – a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals.   
   
     
   
21.02.2012 FDA Accepts Supplemental Biologics License Application Submitted for ACTEMRA®, a Humanized Anti-Human IL-6 Receptor Monoclonal Antibody, Regarding Adult Rheumatoid Arthritis Indication    
Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. President: Osamu Nagayama (hereafter, “Chugai”)] and F. Hoffmann-La Roche Ltd. [Head Office: Basel, Switzerland. CEO: Severin Schwan] announced today that the U.S. Food and Drug Administration (FDA) accepted ...  
   
     
   
20.02.2012 Mabion’s sales are growing    
The company Mabion SA received in the fourth quarter of 2011 over 4.1 million PLN of revenues, compared to 2.8 million PLN in the fourth quarter of 2010. After four quarters of 2011 the company's sales aggregated up to 10.5 million PLN, compared to 3.1 million after four quarters of 2010.    
   
     
   
17.02.2012 European Medicines Agency's Committee For Medicinal Products For Human Use Issues Positive Opinion For Conditional Approval On Marketing Authorization Application For Pixuvri™    
Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that Pixuvri™ (pixantrone dimaleate) has been granted a positive opinion for conditional approval from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP").  
   
     
   
17.02.2012 TheraSphere® Providing Hope to Liver Cancer Patients in Turkey    
Nordion Inc., (TSX: NDN) (NYSE: NDZ), a leading provider of products and services to the global health science market, today celebrated the first anniversary of the market introduction of TheraSphere1, an innovative radioembolic liver cancer therapy, in the Republic of Turkey. The first treatment was administered in Ankara in December 2010. Since then, more than 80 patients have undergone the treatment in more than a half-dozen private and public hospitals across the country.  
   
     
   
16.02.2012 TGA Registration for Cellmid’s Évolis™ Hair Products    
Cellmid Limited (ASX: CDY) advises that it has received TGA registration for its Évolis™ hair growth product range as “listed medicine”. The registration certificates for the Évolis™ for Men and Évolis™ for Women products include the important claims of “promotes hair growth”, “helps prevent hair loss and thinning” and “restores the natural hair growth cycle”.  
   
     
   
16.02.2012 Curetis AG Initiates Prospective Clinical Trial for Rapid Pneumonia Diagnostics    
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.  
   
     
   
16.02.2012 Critical Pharmaceuticals and The University of Nottingham to Develop Nano-Enabled Nasal Spray for Osteoporosis    
Critical Pharmaceuticals, an emerging biotechnology company, and The University of Nottingham today announce a £545,000 collaboration to develop a nano-enabled intranasal formulation of teriparatide for the treatment of osteoporosis. Osteoporosis affects an estimated 75 million people in Europe, US and Japan with more than 180,000 patients suffer fragility fractures in the UK alone each year, at a cost of around £2 billion to the NHS.  
   
     
   
16.02.2012 Genetic Technologies receives CLIA Certificate of Compliance from Centers
 for Medicare and MedicAid Services, USA
   
Genetic Technologies Limited (ASX: GTG; NASDAQ:GENE) is pleased to announce that it has received the Certificate of Compliance for its Australian laboratory under the U.S. Clinical Laboratories Improvements Amendments (CLIA) regulations as administered by the Centers for Medicare and Medicaid Services (CMS).   
   
     
   
16.02.2012 Broadvector completes acquisition of Phase II stage therapy for hip implant failure    
Broadvector Limited (ASX: BDV) has successfully acquired the intellectual property rights to a novel minimally invasive orthopaedic therapy for treating hip implant failure due to aseptic loosening. The intellectual property rights were acquired from UK-based biotech company Innovata Limited, a subsidiary of Vectura Group plc.   
   
     
   
15.02.2012 Amgen and Micromet Announce Early Termination of HSR Waiting Period for Amgen's Acquisition of Micromet    
Amgen (NASDAQ: AMGN) and Micromet, Inc.(NASDAQ: MITI) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, as amended (HSR), in connection with Amgen's tender offer for Micromet, was terminated early on Feb. 14, 2012 by the U.S. Federal Trade Commission.  The waiting period was scheduled to expire on Feb. 17, 2012.      
   
     
   
14.02.2012 Amgen Names Michael Severino, M.D., Senior Vice President, Global Development and Corporate Chief Medical Officer    
Amgen (NASDAQ: AMGN) today announced thatMichael Severino, M.D., has been named senior vice president, Global Development and Corporate Chief Medical Officer, effective immediately. Severino, 46, formerly vice president, Global Development at Amgen, will replace Sean Harper, M.D. Harper, 49, was appointed Amgen's executive vice president, Research and Development.  
   
     
14.02.2012 DNA Electronics CEO Professor Chris Toumazou To Address Scripps “Future of Genomic Medicine” Conference    
DNA Electronics Ltd, a fabless provider of semiconductor solutions for real-time DNA and RNA detection, today announces that DNA Electronics Chairman and CEO Professor Chris Toumazou FRS will be an invited speaker at the upcoming “The Future of Genomic Medicine IV” conference presented by the Scripps Translational Science Institute (March 1-2 2012, La Jolla, California).
   
     
   
14.02.2012 Data confirm excellent safety profile and therapeutic activity    
SuppreMol GmbH, an autoimmune diseases specialist, today announced interim results of the Phase Ib/IIa clinical trial of SM101 to treat Primary Immune Thrombocytopenia (ITP). SM101 was safe and very well tolerated with encouraging efficacy data.  
   
     
   
14.02.2012 AiCuris Drug Letermovir (AIC246) Meets Primary Efficacy Endpoints in Phase 2 For Human Cytomegalovirus (HCMV) Prophylaxis in Human Blood Precursor Cell Recipients    
AiCuris GmbH &Co KG a clinical stage biopharmaceutical company developing drugs against severe infectious diseases, announces positive results from its placebo-controlled and dose-ranging trial with Letermovir (AIC246). In addition to excellent efficacy Letermovir demonstrates superior tolerability and safety and thus defines a novel standard for the control of HCMV in transplant patients.  
   
     
   
13.02.2012 New devices could hold key to predicting premature births    
Scientists and doctors in Sheffield are developing two novel devices that they say could lead to the improved prediction of premature births. Two major trials, together worth nearly a million pounds in funding, are being set up at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield to evaluate the accuracy of the devices.    
   
     
   
13.02.2012 Synthetic Antibacterial Agent, Bactramin® Filed for Additional Indication By “Application Based on Evidence in the Public Domain”    
Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. President: Osamu Nagayama (hereafter, “Chugai”)] announced today that on February 13, it filed an “application based on evidence in the public domain” to the Japanese Ministry of Health, Labour and Welfare seeking approval for...
   
     
   
10.02.2012 Vectron Biosolutions Obtains Strong Results for Biosimilar Production
Vectron Biosolutions announced today that they have obtained strong results for manufacture of selected biosimilar proteins using their proprietary E. coli expression technology. The study was done side-by-side with other expression technologies and Vectron’s technology gave higher soluble and/or insoluble yields for seven out of 10 tested biosimilar proteins. The increase in yield was 2 to 25 times compared to the best conventional technology.    
   
     
   
Cell discovery strengthens quest for cancer treatments    
  Fresh insights into how our cells multiply could help scientists develop drugs to treat cancer. Researchers have gained better understanding of the workings of two key proteins that control cell division. This process must be carried out accurately to keep cells healthy, and when it goes out of control, it can lead to cancer.
 
 
     
   
10.02.2012 Oxford BioMedica plc Management and Board change    
Oxford Biomedica (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that Andrew Wood, Chief Financial Officer, has stepped down from the Board of Oxford BioMedica.   
   
     
   

08.02.2012 Amgen to Discuss Application for New Use of XGEVA® (denosumab) at FDA Oncologic Drugs Advisory Committee Meeting

   
Amgen (NASDAQ: AMGN) will discuss the data from the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases (spread of cancer to the bone) at today's meeting of the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC).  
   
     
   
08.02.2012 Pharmaceutical regulatory affairs specialist ELC Group establishes global HQ in Cambridge, UK    
ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today formally announces that it has established its global headquarters in Cambridge, UK. The opening of the new global HQ follows a year of exceptional revenue growth for ELC Group, and strengthens ELC Group’s ability to serve customers across its major global regions. The Cambridge operation is being headed by Anna Szymanska, General Manager Regulatory Affairs.  
   
     
   
08.02.2012 Full year report 2011 - Lundbeck meets expectations and improves long term growth prospects    
H.Lundbeck A/S (Lundbeck) announces its 2011 results, which fulfil all financial expectations and exceed expectations for revenue. Revenue for 2011 was DKK 16,007 million, an increase of 8% compared to 2010, driven by a positive development in all regions. EBITDA was...  
   
     
   
06.02.2012 First ever innovation credit to develop artificial cornea    
On 6 February 2012 Minister Verhagen awarded Aeon Astron Europe an innovation credit of over €3 million from the Netherlands’ new SME Innovation Credit fund (the Innovatiefonds MKB+). The credit will support the further development of an artificial cornea made of fish scale material. CEO Michael Lai and Vice-President Ingrid Vodegel accepted the innovation credit from Minister Maxime Verhagen and SME chairman Hans Biesheuvel. Aeon Astron Europe is the first company to be awarded this loan from the new Innovatiefonds MKB+, which was launched in January 2012.  
   
     
   
07.02.2012 SATIVEX® Regulatory Approval Received in Austria    
GW Pharmaceuticals (AIM: GWP) today announces a regulatory update for Sativex® (Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)) oromucosal spray. Sativex® has received regulatory approval in Austria as a treatment of spasticity due to Multiple Sclerosis (MS). The launch of Sativex® in Austria is expected to take place during 2012 following completion of the national pricing and reimbursement process. Sativex® will be marketed in Austria by GW's marketing partner, Almirall S.A.  
   
     
   
07.02.2012 Major trial gives hope to motor neurone disease sufferers    
Patients suffering from a devastating disease are being given fresh hope through an innovative trial being led in Sheffield. The trial, which is being led by Sheffield Teaching Hospitals in partnership with the Sheffield Institute for Translational Neuroscience (SITraN) within the University of Sheffield, is using a new device to see if it can help patients with motor neurone disease (MND) – a disease that leads to muscle weakness and ultimately death – to live for longer and with a better quality of life.    
   
     
   
07.02.2012 Sistemic to Work with TiGenix On Landmark EUR 5.9 Million, FP7 European Project Aiming at Developing an Innovative Rheumatoid Arthritis Cell Therapy Treatment Product    
Sistemic is delighted to announce that its proprietary technology (SistemQC™) has been chosen to form a key part of the research and production process for a landmark multinational collaborative project led by TiGenix, Belgium and including partners from Spain, France, the Netherlands as well as the UK and Belgium. The project, REGENER-AR, will bring the first stem cell therapy treatment product for rheumatoid arthritis, Cx611, through final research and clinical development.  
   
     
   
07.02.2012 FDA Grants Genentech’s Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer    
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application for pertuzumab and granted Priority Review.   
   
     
   
06.02.2012 Xceleron Announces New Investment and Move to Purpose-Built Laboratories in U.S.    
Xceleron, a leader in accelerating drug development using ultra-sensitive bioanalytical analyses, today announced that existing investors Albion Ventures and Solon Ventures have invested $2.4MM to locate all of the company’s business in its custom-built facility in Germantown, MD which is expected to be fully operational by 31st March 2012  
   
     
   
06.02.2012 Genetic Technologies executes Settlement and License Agreement  with Eurofins STA Laboratories, Inc.    
In compliance with ASX Continuing Disclosure Rules, Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) is pleased to report that it has executed a Settlement and License Agreement with Eurofins STA Laboratories, Inc. (“Eurofins STA”) of Longmont, Colorado, USA.  Under the Agreement, Eurofins STA is granted non-exclusive rights to a number of GTG patents relating to its non-coding DNA technology.  As with other similar agreements, the precise commercial terms of the Agreement are covered by formal confidentiality provisions and cannot be disclosed.  
   
     
   
06.02.2012 Update On Fondaparinux Sales    
Alchemia Limited announces an update on the sales performance of its marketed product, generic fondaparinux, which was launched in the US in July 2011 by its worldwide marketing partner Dr Reddy’s Laboratories.    
   
     
   
02.02.2012 Phenom-World is launching the Motorized Tilt & Rotation Sample Holder for the Phenom™ desktop scanning electron microscope    
Revealing the hidden treasures of all features on your sample is now possible with the Motorized Tilt & Rotation Sample Holder. Samples can have lines and holes, or have multi-layer structures. The new Motorized Tilt & Rotation Sample Holder allows analysis of the sample from all visible sides and enables a unique 3D image of your sample.  
   
     
     
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