BIOTECHNOLOGY and PHARMA NEWS 2012

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21.05.2012 Capital increase in Lundbeck as a result of employee warrant programme and buy-back of shares to fund Long-Term Incentive scheme    
H.Lundbeck A/S (Lundbeck) today announced that it has decided to increase its share capital by DKK 2,965, as a consequence of the exercise of employee warrants. The increase is affected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following prices per share of nominally DKK 5: 593 shares at DKK 102. Proceeds to the company are DKK 60,486.00 (approximately USD 10,400). The increase corresponds to approximately 0.0003% of the company's share capital.  
   
     
   
21.05.2012 600 Patients Recruited in Active Biotech's and Ipsen's tasquinimod Clinical Phase III Study    
Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that recruitment to the global, pivotal, randomized, double-blind, placebo-controlled phase III study of tasquinimod in patients with metastatic castrate-resistant prostate cancer (CRPC) has reached an inclusion of 600 patients, half of the planned accrual. This triggers a €10 million milestone payment from Ipsen to Active Biotech.  
   
     
   
18.05.2012 Active Biotech and Ipsen to present Tasquinimod Phase II Overall Survival data at the 2012 ASCO Annual Meeting      
Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) will present tasquinimod (TASQ), their prostate cancer drug candidate, at the scientific conference "2012 ASCO Annual Meeting" to be held in Chicago (USA) on 1-5 June 2012. The presentation will provide overall survival (OS) data from the tasquinimod Phase II study in chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC).      
     
     
   
17.05.2012 MolMed clinical development update: six abstracts accepted for presentation at ASCO 2012    
MolMed S.p.A. (Milan:MLM)  today announced that six abstracts featuring its investigational therapeutics NGR-hTNF and TK have been accepted for presentation at the 48th ASCO Annual Meeting, that will take place in Chicago (IL, USA) from June 1-5, 2012. The abstracts are now available on the ASCO 2012 website (http://chicago2012.asco.org/).  
   
     
   
16.05.2012 Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate Of Complete Response In Adult Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia    
Amgen (NASDAQ:AMGN) today announced updated results from a Phase 2 study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72 percent of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study. Blinatumomab is the first of a new class of agents called bi-specific T cell engagers (BiTE®) antibodies, designed to harness the body's cell-destroying T cells...    
   
     
   
15.05.2012 ACADIA Pharmaceuticals to Webcast Educational Program on Parkinson’s Disease Psychosis on May 22, 2012    
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will host a live webcast of its Educational Program on Parkinson’s Disease Psychosis to be held with analysts and investors in New York City on Tuesday, May 22, 2012, from 12:00 p.m. to 1:15 p.m. Eastern Time.  
   
     
   
15.05.2012 MOLOGEN AG: Promising start to 2012 business year - Quarterly report submitted    
The Berlin biotechnology company MOLOGEN AG was able to present very good clinical data from the phase I/II study with product candidate MGN1601 in the area of renal cancer during the first quarter of 2012.  
   
     
   
15.05.2012 OvPlex ™ distribution expands into India    
HealthLinx Limited (ASX:HTX) with distribution partners INEX Innovations Exchange Pte Ltd. and Metropolis Healthcare Ltd. will begin selling OvPlex™ in India 3rd quarter 2012. OvPlex™ will be available in Mumbai, India from August 1, 2012, with extension of distribution to take place through all major Indian cities over the following six months.  
   
     
   
16.05.2012 Hitting the target: IntelliCap provides reliable and accurate regional drug delivery    
Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the GI tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner (Shimizu et al., 2008). This electronic capsule has the added capability of measuring quantitative data such as temperature and pH throughout GI transit.   
   
     
   
14.05.2012 Statistically significant clinical phase III results of Lu AA21004 provide basis for submission of an NDA and MAA for major depression (MDD)    
H.Lundbeck A/S (Lundbeck) today announced positive top-line results from three recently completed phase III clinical studies of Lu AA21004, an investigational drug for the treatment of adults with major depressive disorder (MDD) using dosages from 10 to 20mg.  
   
     
   
14.05.2012 Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commercialization    
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national and international commercialization activities. The performance evaluation of Curetis´ Unyvero™ System and the Unyvero™ P50 Pneumonia cartridge was successfully completed just recently.
   
     
   
14.05.2012 MOLOGEN AG - Excellent outcome for phase 2 colorectal cancer study with MGN1703 - primary endpoint achieved    
The biotechnology company MOLOGEN AG has conducted an initial assessment of the phase 2 colorectal cancer study with MGN1703. The assessment of 55 patients showed that the primary endpoint, the prolongation of the median progression-free survival, was achieved. Progression-free survival describes the period in which a cancer disease does not get worse.  
   
     
   
14.05.2012 Immuron’s Second Travelan Asia Distribution Agreement    
Australian biopharmaceutical company Immuron Limited (ASX: IMC), manufacturer of Travelan®, has entered into an agreement with Singaporean company Ziwell Medical (S) Pte Ltd for the distribution  of Travelan in Singapore, Malaysia and Brunei.    
   
     
   
11.05.2012 Oxford BioMedica Interim Management Statement    
Oxford Biomedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today publishes its interim management statement for the period from 1 January to 10 May 2012.  
   
     
   
11.05.2012 Vetter Boosts Quality and Logistic Processes    
The pharma and biotech industries are increasingly seeking safer and more efficient supply chain processes. To meet these challenges Vetter has invested in a new, state-of-the-art Center for Visual Inspection and Logistics. The new facility offers high-bay warehousing capacity for cool and room-temperature goods employing state-of-the-art technology. The contract development and manufacturing organization (CDMO) is also setting high safety standards for quality control at the location. The 35-million-euro facility will serve as a workplace for up to 400 employees.  
   
   
09.05.2012 Nordion Launches the Gamma Centre of Excellence    
Nordion Inc. (TSX: NDN) (NYSE: NDZ),a leading provider of products and services for the prevention, diagnosis and treatment of disease, today launched the Gamma Centre of Excellence (GCE), a world-class facility for the advancement of gamma sterilization science.  
   
     
   
10.05.2012 Immuron Agreement to Sell Travelan in Thailand, Hong Kong, Cambodia, Vietnam & Laos    
Australian biopharmaceutical company Immuron Limited (ASX: IMC), manufacturer of Travelan®, has entered into an agreement with IntegraMed Asia (Thailand) Co Ltd for the sale of Travelan in Thailand, Hong Kong, Cambodia, Vietnam and Laos.  
   
     
   
10.05.2012 Mucosis Announces Positive Proof-Of-Concept Data for Mimopath® Platform In Humans    
Dutch vaccine development company MUCOSIS B.V. today announced Phase I clinical data providing proof-of-concept that Mimopath®-based mucosal vaccines are safe and well tolerated as well as able to produce balanced immune responses in both circulating blood and the respiratory tract.  
   
     
   
10.05.2012 Definiens Expands Functionality of Its Leading Solution for Quantitative Digital Pathology with Gene Probe Analysis    
Definiens®, the leading provider of image analysis and data mining solutions for quantitative digital pathology, today announced that Definiens Tissue Studio® 3.5 now supports the automated analysis of in situ hybridization assays, including SISH, CISH, FISH and dual-ISH.  
   
     
   
10.05.2012 Cell Therapeutics' Pixuvri® Approved in European Union as Monotherapy to Treat Adult Patients with Multiply Relapsed or Refractory Aggressive Non-Hodgkin B-Cell Lymphomas    
Cell Therapeutics, Inc. ("CTI" or the "Company") (NASDAQ and MTA: CTIC) today announced that it has received conditional marketing authorization from theEuropean Commission ("EC") for Pixuvri® (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL"). Pixuvri is the first approved treatment in the European Union ("EU") in this patient setting.  
   
     
   
09.05.2012 Nordion Launches the Gamma Centre of Excellence    
Nordion Inc. (TSX: NDN) (NYSE: NDZ),a leading provider of products and services for the prevention, diagnosis and treatment of disease, today launched the Gamma Centre of Excellence (GCE), a world-class facility for the advancement of gamma sterilization science.  
   
     
   
09.05.2012 Cancer Support Community Launches National Program to Assist Patients With Cancer, Make Informed Decisions About Care    
The Cancer Support Community(CSC) and the Amgen Foundation, today announced the launch of Open to Options?, a program designed to bridge the communications gap between physicians and patients and inspire patient confidence in making treatment decisions. Following a successful pilot funded by the Centers for Disease Control (CDC), the Open to Options program is ready to provide professional counselors who help more people formulate a list of personalized questions and concerns to be taken into the oncologist's office.  
   
     
   
09.05.2012 Nuevolution Announces Receipt of Milestone Payment from Boehringer Ingelheim    
Nuevolution A/S today announced that it has received a milestone payment derived from its collaboration with Boehringer Ingelheim. The payment was triggered following identification of potent small molecule compounds that have been shown to disrupt the protein-protein interaction of an undisclosed therapeutic target.  
   
     
   
09.05.2012 Lundbeck announces the resignation of Marie-Laure Pochon, Executive Vice President, Commercial Operations    
H.Lundbeck A/S (Lundbeck) today announced that Marie-Laure Pochon, Executive Vice President, Commercial Operations, has decided to resign from her position at Lundbeck for family and private reasons.  
   
     
   
09.05.2012 Technologies Executes Settlement and License Agreement with GeneSeek 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 GeneSeek Inc. (“GeneSeek”) of Lincoln, Nebraska, USA (see: http://www.neogen.com/geneseek/).  Under the terms of the Agreement, GeneSeek is granted certain non-exclusive rights to a number of GTG patents relating to its non-coding DNA technology.

 
   
     
   
08.05.2012 ACADIA Pharmaceuticals Reports First Quarter 2012 Financial Results    
ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced its unaudited financial results for the first quarter ended March 31, 2012.    
   
     
   
08.05.2012 Oxford BioMedica Announces Presentation of Ocular Clinical Data at 2012 ARVO Annual Meeting    
Oxford Biomedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that data from its ocular programmes partnered with Sanofi (EURONEXT: SAN and NYSE: SNY) were presented at the 2012 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida (USA).  
   
     
   
08.05.2012 New data presented at the 2012 Annual Meeting of the American Psychiatric Association (APA) suggest that Lu AA21004 may have positive effect on cognitive dysfunction in patients with major depressive disorders    
H.Lundbeck A/S today announced the presentation of new data on Lu AA21004, an investigational compound for the treatment of major depressive disorder (MDD), at the 165th Annual Meeting of the American Psychiatric Association (APA) in Philadelphia, USA. The presentations included results from clinical phase III studies as well as non-clinical data.  
   
     
   
07.05.2012 esults from a clinical phase III study of once-monthly aripiprazole IM depot formulation for the maintenance treatment of schizophrenia presented at APA    
H.Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced results from a clinical phase III clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia. Trial results were presented in four poster presentations at the 165th Annual Meeting of the American Psychiatric Association (APA) in Philadelphia, USA.   
   
     
04.05.2012 European Cystic Fibrosis Society Diagnostic Network Group  evaluated a new tool for Cystic Fibrosis  diagnosis    
Last February TECIL participated in the Meeting of the ECFS DNWG. The European Cystic Fibrosis Society Diagnostic Network Working Group (ECFS DNWG) was set up to evaluate new diagnostic techniques and to standardize procedures throughout Europe.    
   
     
   
04.05.2012 BIAL Established as new Marketing Partner for Medigene's Drug Veregen® in Spain and Portugal    
MediGene AG (Frankfurt, Prime Standard) (MDG, Frankfurt, Prime Standard) announces that its drug Veregen® will now be marketed by BIAL Industrial Farmaceutica, S.A., with immediate effect. This announcement follows an agreement between Medigene, its previous partner Juste S.A.Q.F and the Portuguese pharmaceutical company BIAL. Market launch of Veregen® ointment in Spain remains scheduled to take place in the second quarter of 2012.  
   
     
   
03.05.2012 Roche Reports Positive Study of RoACTEMRA Given by Subcutaneous Injection    
Roche today announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy of the subcutaneous (SC) formulation of RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) 162 mg weekly compared to 8 mg/kg RoACTEMRA intravenous (IV) formulation every 4 weeks. A similar proportion of rheumatoid arthritis (RA) patients in each group achieved an ACR20 response at Week 24, a measure indicating improvement in the number of tender and swollen joints, pain scale, patients’ and physicians’ assessment of improvement and certain laboratory markers.  
   
     
   
03.05.2012 Sartorius Stedim Biotech and c-LEcta Sign Sales Agreement    
Sartorius Stedim Biotech (SSB),  a leading international pharma and biotech supplier, and the biotechnology specialist c-LEcta, announce the signing of a worldwide sales and distribution agreement for c-LEcta’s proprietary Serratia marcescens nuclease for biopharmaceutical applications. The German company specializes in the development of customized enzymes and production strains for industrial applications. Based on this agreement, customized endonuclease will now be available under the product name “Denarase” through all regular Sartorius Stedim Biotech sales channels.  
   
     
   
03.05.2012 Jean-Paul Prieels joins VAXIMMs Board of Directors    
VAXIMM AG, a Swiss-German biotech spin-off from Merck KGaA focusing on cancer vaccines, announced today the appointment of Jean-Paul Prieels as a new member of its Board of Directors.  
   
     
   
03.05.2012 Genentech Reports Positive Study of Actemra Given by Subcutaneous Injection    
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy (non-inferiority) of the subcutaneous (SC) formulation of ACTEMRA (tocilizumab) 162mg weekly compared to 8 mg/kg ACTEMRA intravenous (IV) formulation every four weeks. A similar proportion of rheumatoid arthritis (RA) patients in each group achieved an ACR20 response at Week 24, a measure indicating improvementinthe number of tender and swollen joints, pain scale, patients’ and physicians’ assessment of improvement and certain laboratory markers.  
   
     
   
02.05.2012 Nanobiotix and Thomas Jefferson University Start Research Collaboration    
Nanobiotix, a company developing novel cancer nanotherapeutics and Thomas Jefferson University, one of Philadelphia’s premier medical and health sciences universities, today announced that they have entered into a research collaboration to accelerate the development of Nanobiotix’ lead compound NBTXR3 in the US. Under the terms of the collaboration agreement, Nanobiotix will fund a 2-year preclinical research program, which will be directed by Bo Lu, MD, Professor...  
   
     
   
02.05.2012 New product launches on track and revenue continues to show growth, excluding Lexapro (US)    
Excluding Lexapro® revenue in the US, H.Lundbeck A/S reports first quarter revenue of DKK 3,442 million, corresponding to an increase of 2%. Including revenue from Lexapro revenue was DKK 3,778 million. Operating profit before depreciation and amortisation (EBITDA) was DKK 1,123 million, corresponding to an EBITDA margin of 29.7%. Profit from operations (EBIT) was DKK 882 million, corresponding to an EBIT margin of 23.3%. Profits were affected by the increase in launch costs related to Lundbeck’s newer products, as well as the loss of revenue from Lexapro due to generic competition.  
   
     
     
02.05.2012 Medigene Obtains U.S. Patent for EndoTAG®-1 for the Treatment of Triple-Negative Breast Cancer      
MediGene AG (Frankfurt, Prime Standard) has obtained an additional patent for oncology drug candidate, EndoTAG®-1, from the United States Patent and Trademark Office. Patent No. 8,168,216 protects the use of EndoTAG®-1 in combination with taxanes for the treatment of triple-negative breast cancer (TNBC). This drug combination was successfully tested in a phase II clinical trial in patients with TNBC. This newly granted patent broadens the existing EndoTAG®-1 patent portfolio and has a regular term until April 2029.      
     
     
     
01.05.2012 ACADIA Pharmaceuticals to Announce First Quarter 2012 Financial Results on May 8, 2012    
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will report its unaudited financial results for the first quarter ended March 31, 2012 on Tuesday, May 8, 2012, after the U.S. financial markets close. ACADIA's management will host a conference call and webcast on Tuesday, May 8, 2012, at 5:00 p.m. Eastern Time to discuss ACADIA’s financial results and development programs.     
     
     
     
01.05.2012 Hatchtech appoints new CEO and completes financing round     
Specialty pharmaceutical company Hatchtech Pty Ltd has appointed Dr Ross Macdonald as its Chief Executive Officer. The company has also secured additional capital, bringing total funds raised in the current round to AUD7.8 million.      
     
     
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