TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and CE certification for the European market in a time- and cost-efficient manner with TÜV SÜD.

Dossier - 21/05/2013

No new drugs to be placed on the market without clinical trials

New pharmaceuticals are subject to approval by drug authorities. Here clinical trials are performed to ensure the quality efficacy and safety of a medicinal product. Clinical development is a time-consuming and costly process and takes on average ten to fifteen years before a pharmaceutical company can apply for the approval of the drug. The costs including failures can amount to approximately one billion US dollars per drug.

nanodiag BW has received approval from the BMFTR for a further three-year implementation phase under the Clusters4Future initiative. With the approval of €15 million, the innovation network will be able to continue its work on nanopore-based diagnostic methods seamlessly from April 2026 onwards. The Baden-Württemberg Ministry of Economic Affairs, Labour and Tourism is supporting the cluster management through accompanying measures.

On December 13, 2022, the European Commission granted approval to a drug against metastatic prostate cancer whose active ingredient was developed under the leadership of the German Cancer Research Center (DKFZ) in collaboration with Heidelberg University Hospital and Heidelberg University. The drug can significantly improve the survival chances of patients.

On March 23, 2022, the U.S. Food and Drug Administration (FDA) granted approval to the first targeted radioligand therapy against metastatic prostate cancer based on a joint patent of the German Cancer Research Center (DKFZ) and the University of Heidelberg. The agent significantly improves the chances of survival for those affected.

In the current selection round, the German Research Foundation (DFG) has granted funding for two new Collaborative Research Centres at the University of Konstanz. Over the next four years, the research teams will be working intensively on trigger signals in biological cells as well as on "silence" and "noise" in human speech.

With the "Česká Hlava" awards, the Czech government has been honoring the country's most brilliant minds every year since 2002 and recognizing exceptional achievements in research, development and innovation. Martina Benešová-Schäfer of the German Cancer Research Center was among the six laureates honored in 2022 at Charles University in Prague.

Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101. Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).

CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the strategic decision to focus its COVID-19 vaccine development towards the development of second-generation mRNA vaccine candidates in collaboration with GSK and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process.

Bayer has signed a collaboration and services agreement with CureVac, a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid. Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate CVnCoV.

Vaccine development - 25/05/2021

Vaccines - a beacon of hope in the fight against pandemics

Having long been considered less lucrative for the big pharmaceutical companies, vaccine development is taking off in an unforeseen way in the wake of the COVID-19 pandemic. Financial support is flooding in and all kinds of vaccine development strategies are being deployed. Among the winners in the competition for effective coronavirus vaccines are vaccines based on RNA technology.

Chronic inflammatory bowel diseases - 25/09/2024

Proinflammatory regulatory T lymphocytes as a therapeutic target in Crohn's disease

Chronic inflammatory bowel diseases are very stressful for those affected and increase the risk of bowel cancer. PD Dr. Robyn Laura Kosinsky from the Bosch Health Campus in Stuttgart, together with researchers from the USA, identified disfunctional regulatory T cells as important drivers of inflammation in Crohn's disease. They also found that with the help of an epigenetically active drug, it was possible to restore the cells’ original…

Atriva Therapeutics - 21/10/2020

COVID-19 pioneer drug in Phase II clinical trial - with double the power

The effective treatment of people with severe COVID-19 is a major goal during the corona pandemic. ATR-002, an oral small molecule that targets RNA viruses such as influenza virus and SARS-CoV-2, has a dual effect: it impairs viral propagation and also has an immunomodulatory effect. And what’s more, due to its unique cellular mechanism of action, the efficacy of Atrivia Therapeutics’ drug candidate is not reduced by virus mutations and…

What a success for Ulm University and its medical centre! The German Research Foundation (Deutsche Forschungsgemeinschaft; DFG) extends the Collaborative Research Centre (CRC) on Trauma Medicine for the second time. The third funding phase infuses the CRC 1149 'Danger Response, Disturbance Factors and Regenerative Potential after Acute Trauma' with 11.1 million euros.

The recently established ITCC-P4 gGmbH provides academic institutions and pharmaceutical companies with a comprehensive repertoire of modern laboratory models of pediatric tumors. The aim is to systematically test new treatment options for children and adolescents with cancer and to contribute data to regulatory approval processes in order to make the development of new cancer therapies for children and adolescents more attractive.

Evotec SE announced today the launch of beLAB2122 in the Rhine- Main-Neckar region to efficiently advance first-in-class therapeutic concepts into investable drug discovery projects. Mediated and supported by BioRN, Evotec’s newest BRIDGE brings together the European Molecular Biology Laboratory (“EMBL”), the German Cancer Research Center (“DKFZ”), the Goethe University Frankfurt, Heidelberg University and the University of Tübingen.

Development of the genomDE genome database - 04/12/2020

Whole genome sequencing for diagnosing rare diseases

Grouped together, rare diseases are by no means a rare phenomenon; however, they are rarely correctly diagnosed and rarely properly treated. In most cases, there is no effective medication available. Rare disease centres staffed by experts have been set up in many German cities to speed up the often long and painful search for the right diagnosis and treatment. Whole genome sequencing is a component of general healthcare, used to identify…

Young patients suffering from two aggressive sarcoma types can now participate in the innovative PAMSARC therapy study at the NCT Heidelberg. The study uses molecular biological methods and tests the extent to which a new drug can improve the poor prognosis for these tumours.

Digitalisation in Medicine - 08/12/2020

DiHeSys takes steps towards application

Digital Health Systems GmbH (DiHeSys) has completed its founding phase and entered a new stage of development. This is reflected in the arrival of a new managing director, a strategic cooperation and its first pilot projects.

Dossier - 01/04/2013

Retroviruses from infectious agent to therapeutic assistant

Viruses are infectious particles that use the machinery and metabolism of a host cell to replicate. The family of retroviruses is particularly known for its most notorious representative i. e. the human immunodeficiency virus HIV. However retroviruses are not only of interest for researchers looking for effective cures for viral infections their characteristic properties also make them promising laboratory and gene therapy tools.

Chordomas are rare bone tumors for which there are no effective drugs. A research team from the DKFZ and the NCT Heidelberg has now developed a promising approach: Tailor-made mini-proteins specifically block the driver of tumor development. In the result, slowing the growth of chordoma cells in the laboratory and in a mouse model, while also revealing further molecular vulnerabilities of the tumor that could be addressed with approved drugs.

Dossier - 13/04/2015

Boosting the immune system can improve cancer prevention and treatment

The activation of the body’s immune system to fight cancer is not only a promising therapeutic concept, but is already used in medical practice. The first immunotherapies have been approved and many more are either in the experimental stages or already undergoing clinical testing. Vaccines to prevent certain types of cancer are already being used successfully around the world.

Today, the EU Parliament adopted the EU Regulation on Health Technology Assessment (HTA), which includes not only new medicines (including gene and cell therapies), but also medical devices.

Dossier - 17/01/2017

Phytopharmaceuticals – fighting disease with natural substances

Phytopharmaceuticals are herbal medicines whose efficacy is down to one or several plant substances or active ingredients. They have been used for treating diseases since time immemorial. This traditional knowledge is still the basis for many medicinal products made from plants or parts thereof. Herbal medicines have been produced in Baden-Württemberg for many generations.

Article - 04/11/2020

Rapid coronavirus test delivers results in 43 minutes

The Hahn-Schickard Institute and Spindiag GmbH in Freiburg im Breisgau have joined forces to develop a rapid test used at the point of care. The test takes just 43 minutes to show whether a patient is infected with the coronavirus SARS-CoV-2. The rapid test is expected to be given market approval in Germany and the EU during the final quarter of 2020.

At the University Hospital Tübingen, clinical evaluation of an in-house developed vaccine (CoVac-1) against SARS-CoV-2 was started in November 2020 under the direction of Prof. Dr. Juliane Walz in the CCU Translational Immunology of the Medical Clinic (Medical Director Prof. Dr. Helmut Salih). Now the results of the Phase I study are available and demonstrate a potent activation of the T-cell response against the coronavirus.

A recent article by Prof. Dr. Martin Haimerl and Prof. Dr. Christoph Reich of Furtwangen University shows that machine learning (ML) in medicine is often evaluated without a comprehensive risk assessment. The authors investigated the extent to which current scientific papers include risk-based metrics in the evaluation of AI models for medical devices.

This year Furtwangen University (HFU) is launching the “HFU Skills4MedTec” project to further enhance its profile as a leading authority in medical technology and to develop targeted scientific training courses for specialists and managers in the industry.

In the current approval round of the German Research Foundation (DFG) Heidelberg University has been successful with six applications for grants to fund major, internationally visible research consortia. The six research consortia − three of them will reach the maximum funding length of twelve years after their extension − are to receive financial resources totalling nearly 87 million euros over a period of four years.

Heidelberg University has been successful in the current approval round of the German Research Foundation (DFG) with three grant applications for major research consortia. In the life sciences and medicine, a Collaborative Research Centre working on the Wnt signaling pathway will enter its third funding period. Two transregional consortia with major participation by researchers from Ruperto Carola have also been extended.

Article - 14/04/2021

Calling for quality seal for implants

Today's seniors are older and more active, which is why implants remain in the body longer and are subjected to greater strain than before. Improved surfaces are expected to ensure that the implants heal and integrate into the bone optimally. In an interview with BIOPRO, Dietmar Schaffarczyk, CEO of Konstanz-based stimOS GmbH, explains why a voluntary quality seal makes sense and gives consumers a better chance of recognising high-quality…

Dossier: Innovative animal-free research in Baden-Württemberg - 05/12/2024

Mini-organs and multi-organ chips - where lab mice may soon retire

Farewell to animal testing? Life sciences researchers in BW are pioneering innovative methods to replace animal experiments, reduce the number of animals used and refine the procedures and conditions under which animals are kept. These are the guiding principles of the 3Rs principle. Developing cutting-edge models and establishing a robust 3R network, not only shapes the future of research but also improves the quality of scientific outcomes.

Since 2019, the Research Training Group (RTG) "Intraoperative Multisensoric Tissue Differentiation in Oncology," a collaboration between the University of Stuttgart and the University of Tübingen, has been advancing research in medical technology. With the help of new sensor methods, the researchers want to help make surgical procedures on cancer patients safer and more effective.

Article - 22/10/2019

Using CAR T cells for treating cancer

After successes in the treatment of advanced blood cancers, CAR T-cell immunotherapy has become a major beacon of hope in oncology. The first therapies have received regulatory approval. Despite their success, these immunotherapies can have serious side effects. The company AVA Lifescience develops antibodies with high tumour specificity to use as the basis for effective precision-guided CAR T-cell therapies that are better tolerated by patients.

Atriva Therapeutics GmbH, a company that is pioneering the development of therapies for the treatment of viral infections, has secured up to €11.4 million in federal funding. The company, founded in 2015, announced today that it was selected for research funding from the German Federal Ministry of Education and Research (BMBF). Atriva will use the funds to advance its drug ATR-002 towards market maturity as quickly as possible.

Innovative Therapies - 20/08/2020

Labor Dr. Merk is fully committed to viral therapies

Labor Dr. Merk & Kollegen is reorienting its business towards viral therapeutics. With this change of strategy, the company, which has decades of expertise in virology, wants to position itself in a timely fashion in the growing new market for advanced therapy medicinal products (ATMP). In gene and virotherapies (oncolytic viruses), tumour vaccines and CAR-T cell therapies, viruses are essential as vectors, killers of tumour cells or…

Inovedis GmbH’s innovative implant - 28/03/2023

Next-generation minimally invasive shoulder surgery

The treatment of shoulder injuries such as rotator cuff tears is one of the most common orthopaedic interventions. It is therefore quite surprising that the surgical procedure has not changed much for decades - although it is relatively complicated. The start-up Inovedis has now developed a completely new surgical technique based on an implant that can be performed simply, safely, quickly and cost-effectively with minimal stress for patients.

Dossier - 04/11/2013

Biotechnology driver of innovation in the pharmaceutical industry

The biotech industry is the innovative driver for a pharmaceutical industry that, due to the shift from blockbluster products to personalised medicine, now depends on new concepts. The production of new drugs using genetic engineering relies on knowledge gained from genomics, proteomics and systems biology and creates new treatment strategies that combine therapy and diagnostics (i.e. companion diagnostics) to provide a specific individualised…

Between conservative and surgical intervention - 04/12/2025

Innovative tubular prosthesis enables reversible treatment for type 2 diabetes

Severe obesity is considered a major cause of type 2 diabetes. Building on gastric bypass surgery, the Mannheim-based company Trans-Duodenal Concepts has developed an endoscopically implantable tubular prosthesis that lines the duodenum. This both reduces food intake and can restore normal blood sugar metabolism.

CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the publication entitled “Therapeutic HNF4A mRNA attenuates liver fibrosis in a preclinical model” in the peer-reviewed Journal of Hepatology.

Heidelberg Epignostix GmbH, a deeptech start-up committed to precision cancer diagnostics today announces €4.3M in seed funding. This investment will enable Heidelberg Epignostix to make a substantial leap forward in driving market development for its flagship indication for brain tumor classification.

Encouraging results from a large international study led by Heidelberg have recently been published in the journal “Lancet”: The genetic material of cancer cells with unknown tissue of origin contains numerous targets for specific drugs that are already available and have been developed to treat other forms of cancer. These suppressed the disease in CUP patients for significantly longer than chemotherapy.

Acquisition will strengthen the mRNA-based cancer immunotherapy candidates, marking BioNTech’s milestone in its oncology strategy. Acquisition of CureVac will complement BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. All-stock acquisition has potential to create value for both companies’ shareholders given their complementary capabilities, focus on mRNA, and shared vision.

With its "Proof of Concept" grants, the European Research Council ERC supports scientists in further developing the commercial potential of their research results. Nina Papavasiliou from the DKFZ is now receiving the prestigious grant for the second time: she wants to advance the development of a "molecular delivery service" that ensures that therapeutic genes reach the right address in the body in a targeted manner.

Expert interview - 08/03/2023

How do new active substances from university research reach patients?

Access to capital remains one of the biggest challenges in the life sciences sector. Over the last two years, the Baden-Württemberg Center for Academic Drug Discovery (BWCAD2) has successfully implemented a model of cooperation between academic drug research and industry for the development and validation of therapeutic concepts. Dr. Barbara Jonischkeit spoke with the initiator and leading figure behind the BWCAD2 project, Prof. Dr. Stefan Laufer

UKCA product marking - 18/12/2024

New medical device marking requirements and regulations in Great Britain

Since Brexit, additional regulations for medical devices have come into effect in Great Britain, i.e. England, Wales and Scotland. Although the transition periods have been extended, medical device manufacturers should familiarise themselves with the new conformity marking requirements. EU medical device regulations will continue to apply in Northern Ireland.

Triple-negative breast cancer (TNBC) is the most aggressive and deadly form of breast cancer with limited treatment options. Tumor growth and relapse of TNBC are driven by breast cancer stem cells, and improved therapies that can eliminate those hardy cells are urgently needed. Researchers from the University of Frieburg discovered that coordinated differentiation and changes in the metabolism of breast cancer stem cells make them invisible for…

Many people with cancer experience dramatic loss of muscle and fat tissue. In many cases, even the heart muscle is affected. This wasting syndrome, affects around half of all cancer patients. Researchers from Helmholtz Munich, in collaboration with Heidelberg University Hospital, the Technical University of Munich, and the German Center for Diabetes Research, have now identified a previously overlooked driver of cachexia: the liver.

Mosses for pharmaceutical production - 16/09/2020

Factor H as a therapeutic option for viral diseases - including COVID-19

The search for drug candidates for COVID-19 diseases is well underway. Factor H, which is part of the innate immune system, might also be a future therapeutic option. The Freiburg-based biotech company eleva has developed a technology for producing this human protein in moss cells. The active ingredient, which might also have a regulatory effect in other diseases, is currently undergoing preclinical testing.

Article - 18/03/2019

EHR and PHR: digital records in the German healthcare system

EHRs, i.e. electronic health records (German: Patientenakte, ePA), are hailed as the key to increasing the quality of care. The Appointment Service and Supply Act (TSVG), adopted on 14th March 2019, requires the German statutory health insurance funds to provide policyholders with electronic health records from 1st January 2021 onwards.