Healthcare industry

Article - 14/01/2009

Strict requirements for the market approval of tissue engineering products

New regulations for the marketing approval of advanced therapy medicinal products have applied in the EU since December 2008. Prof. Sabine Kloth from TÜV SÜD Product Service GmbH is an expert in materials of animal origin and has been closely following the formulation of the ATMP Regulation.

Protein kinases are a major focus of modern cancer research. Since it has become known that these enzymes play a role in the development of tumours, researchers around the world are concentrating on finding drugs to inhibit overactive protein kinases and prevent cancer cells from growing. One of these active substances is currently being tested at the Tumour Biology Centre in Freiburg as part of a worldwide phase III clinical trial.

The German regulatory authority has approved the Clinical Trial Application CTA to begin a Phase I clinical study with RNActive - derived mRNA vaccine CV9103. It will be tested in patients with hormone-refractory metastatic prostate cancer.

The actual age of a person not only depends on the date he or she was born. Biological age, which is far more important in determining lifespan, can so far only be estimated rather than precisely calculated. The European MARK-AGE research project is working on finding a solution to this problem. Esslingen plays a major role in this project for two reasons: the structure of the city and the company BioTeSys.

Karen Grave-Hermann and Dr. Robert Hermann founded cr.applications in 2003. The two specialists who have wide-ranging experience in drug development talked to Michael Statnik about current trends in their field and about the development of the German biotech sector.

Boehringer Ingelheim has three oral compounds for the treatment of diabetes type II in phase II and III of clinical development. The most advanced compound a DPP-4 inhibitor is in the final clinical phase.

A consortium is providing funding for the development of Phenex drug candidates for type 2 diabetes and metabolic syndrome. Phenex will take its metabolic syndrome drug candidates into Phase I clinical testing by early 2010 at the latest.

Duchenne muscular dystrophy DMD is a severe disease affecting boys characterised by rapid progression of muscle degeneration so that boys as young as 10 to 12 years of age have to use a wheelchair and leading to death in young men. In Germany about 2500 children and young adults suffer from DMD.

The Lake Constance region offers a broad range of cancer therapies and is home to several institutes and companies that are dealing with cancer research. The BioLAGO biotechnology network offers them a joint platform for co-operation and exchange of information.

The medical importance of vitamin D calciferol is most likely even higher than suggested by recently published studies. A study which also involves the endocrinologist Bernhard Böhm from Ulm has attracted enormous attention as it suggests that vitamin D deficiency increases mortality.

Under the agreement Nycomed will receive the exclusive worldwide rights to develop manufacture and commercialise the subcutaneous formulation of veltuzumab for the treatment of all non-cancer indications.

Frank Kirchhoff an AIDS researcher from Ulm has learnt to pose important questions and find the right answers during his post-graduate studies. This recipe has brought him and his research group international recognition and makes him one of the best AIDS researchers worldwide. Important publications within a very short time and numerous awards are clear evidence of his outstanding achievements. In addition he has just started a clinical trial…

About a year ago Prof. Dr. Martin Schwemmle and his team at the University Hospital of Freiburg discovered a new starting point in the fight against the H5N1-virus. In the meantime the scientists are working together with the company Pike Pharma to develop a compound.

DFG and BMBF will provide 15 million euros per year each starting in 2009.

CureVac GmbH has entered into a partnership with the Department of Urology University of Florida Gainesville U.S. to jointly advance its lead candidate CV9103 into the clinical development. The alliance covers preclinical studies and a US phase III trial.

Article - 28/04/2008

A milestone in the treatment of leukaemia

Blood cancer experts in the team of Professor Peter Dreger Head of the Section of Allogeneic Stem Cell Transplantation at the University Hospital of Heidelberg have achieved a major success in the treatment of leukaemia. For the 500th time the physicians from the Department of Haematology Oncology and Rheumatology transferred blood stem cells from a healthy donor to a patient suffering from leukaemia or lymphoma.

The company Rentschler from Laupheim in the south of Germany is nowadays one of the biggest biopharmaceutical contract manufacturers in Europe. This has not always been the case. A look at the companys history shows why the company which is nowadays run by the third family generation has become what it is today.

Dossier - 24/04/2008

Contract manufacture: the order books remain full

The market for therapeutic proteins is continuing to grow in double figures. Current estimates of the total market value are in the range of 60 to 70 billion US dollars and the market is estimated to grow by 13 per cent p.a. up until 2010. Biopharmaceutical contract manufacturers have established themselves on the market and market observers estimate that the number of biopharmaceutical medicines will grow from 100 2005 to approx. 150 until 2010.

In the second article in the series on the platforms successful cooperations BioValley presents an encouraging approach for improving the quality of life of severely ill cancer patients and the successful establishment of an industrial biochip platform.

The first European Conference for Clinical Nanomedicine is to be held soon in Basel. BIOPRO has therefore discussed this promising area of application with Beat Löffler and Dr. Patrick Hunziker the founders of the European Foundation for Clinical Nanomedicine.

Article - 16/03/2008

New indication for lead compound of Apogenix

Isolated tumour cells use to invade healthy brain tissue during the development and growth of glioblastoma multiforme GBM. This mechanism involves the CD95CD95L death system. These results supports the therapeutic potential of Apogenix APG101 for the treatment of glioblastomas.

Dr. Gilbert Gorr has been fascinated by the moss Physcomitrella patens for many years in fact it occupies a great deal of his waking moments. The enthusiasm with which the CSO of greenovation Biotech GmbH talks about the key object of his work is both intoxicating and contagious. The latest discovery The moss produces a therapeutic antibody that is far more effective than its predecessors created in animal cell cultures.

Young medical professionals or young scientists are eligible to apply for funding.

Article - 05/02/2008

Protecting the liver from oxygen stress

The Emmy Noether junior research group in the Department of Surgery at the University Hospital of Heidelberg is to be funded with 1.2 million over the next five years. The group will focus on how tissue damage in donor livers can be prevented. The group headed by Dr. Martin Schneider.

Gender-specific differences are currently not only a subject of debate for experts but have also raised broad media interest. However there are very few specific investigations that are able to provide a clear answer said Prof. Volker Kühlkamp chief physician in the Department of CardiologyElectrophysiology at the Lake Constance Heart Centre in ConstanceKreuzlingen and specialist in cardiac arrhythmia.