In Depth 11 Nov 2020 GMO Regulations in Europe Are “Not Fit for Purpose” The controversial decision by the European courts in 2018 to regulate gene-edited organisms as GMOs has had a damaging effect on biotech companies working in this area. The current GMO regulations were established in Europe in 2001 and were designed to strictly regulate the introduction of DNA from other species into animals and plants. These […] November 11, 2020 - 8 minutesmins - By Helen Albert Share WhatsApp Twitter Linkedin Email
In Depth 5 Oct 2020 The Complications Around Patenting Biotechnology Many people around the world start their mornings with a glass of orange juice. What these vitamin C drinkers might not know is that their ability to enjoy this tangy beverage stems from a victory within a complicated field of intellectual property law: biotechnology patents. Back in 1873, microbiologist Louis Pasteur patented a new yeast-making […] October 5, 2020 - 7 minutesmins - By External Contributor Share WhatsApp Twitter Linkedin Email
Expert Advice 1 Jul 2020 Why Biotech Must Change its Cleaning and Disinfection Strategy Many biotech companies deploy strong chemicals to clean and disinfect their equipment. However, if handled in the wrong way, this can lead to dangerous problems such as antibiotic resistance. As the EU prepares to release new guidelines on good manufacturing practices, it’s time to revise how cleaning is approached in the industry. To effectively control […] July 1, 2020 - 10 minutesmins - By Melanie Maria Obermeier Share WhatsApp Twitter Linkedin Email
In Depth 8 Jun 2020 Regulations on Genetic Data Could Threaten Genomics Innovation As genetic research relies more and more on digital technology, international regulations are straining to catch up and some fear they threaten to stifle innovation. Is it possible to develop a regulatory framework for genetic data that is fair for everyone? In just a couple decades, the digital revolution has taken over all sorts of […] June 8, 2020 - 6 minutesmins - By External Contributor Share WhatsApp Twitter Linkedin Email
News and Trends 5 Nov 2019 EU Regulations Are Holding Back Gene and Cell Therapy Clinical Trials European regulations might be responsible for lower numbers of advanced therapy clinical trials running in the region when compared to the US and Asia. Europe has historically been a pioneer in advanced therapies, such as cell and gene therapy. Europe was the first region to approve a gene therapy, and it boasts the highest number […] November 5, 2019 - 4 minutesmins - By Clara Rodríguez Fernández Share WhatsApp Twitter Linkedin Email
News and Trends 22 May 2019 Microbiome Companies Unite to Push for EU Regulation Reform European microbiome biotechs have launched a collaboration to streamline the EU’s regulatory pathways for microbiome-based treatments, which have the potential to treat inflammatory disease and bacterial infection. The companies will propose EU regulatory changes that make it easier to commercialize treatments based on targeting a patient’s microbiome bacteria. Microbiome-based treatments form a young field in […] May 22, 2019 - 2 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 25 Apr 2019 Horizon Europe Scheme Gets EU Parliament Approval The proposed Horizon Europe research funding scheme, the new Horizon 2020, has had approval from the EU parliament to launch in 2021. Since 2014, the EU research initiative Horizon 2020 has been providing funding for European innovation in biotech as well as other areas of research in academia and industry. The successor program of Horizon […] April 25, 2019 - 2 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
In Depth 25 Mar 2019 Where Does Brexit Leave European Biotech? In the next couple of months, the UK will officially exit the EU, in a move that is popularly known as Brexit. With this date fast approaching, companies, organizations and individuals all over the world have speculated about how Brexit might impact them. According to the UK Prime Minister, Theresa May, at the launch of […] March 25, 2019 - 9 minutesmins - By Karen O’Hanlon Cohrt Share WhatsApp Twitter Linkedin Email
News and Trends 6 Sep 2018 More Brexit Bad News: EMA Pulls Contracts Early From UK Regulatory Body The European Medicines Agency (EMA) has pulled all contracts with the UK’s medical regulation body ahead of the UK withdrawing from the EU next year. Until 2018, the EMA has relied on the UK Medicines & Healthcare products Regulatory Agency (MHRA) to assess 20–30% of its drugs on a contract basis, work worth approximately €15.6M […] September 6, 2018 - 2 minutesmins - By Helen Albert Share WhatsApp Twitter Linkedin Email
News and Trends 2 Aug 2018 EMA Temporarily Scales Back Activities to Prepare for Brexit As a result of Brexit, the European Medicines Agency will suspend some of its activities to prepare for staff cuts and its move from London to Amsterdam next year. As of October 1st, the EMA will cut back on international collaborations, developing guidelines for regulatory approval, and publishing clinical data in order to maintain its […] August 2, 2018 - 2 minutesmins - By Alexander Burik Share WhatsApp Twitter Linkedin Email
News and Trends 26 Jul 2018 EU Court of Justice Makes Restrictive Ruling on Genome Editing Genetically-edited organisms that were until now excluded from GMO regulation will now be subject to EU GMO law, which according to experts could harm Europe’s leading position in genome editing. Following a petition from France’s Council of State, the Court of Justice of the EU has stated that mutagenesis techniques should be regulated under GMO […] July 26, 2018 - 3 minutesmins - By Clara Rodríguez Fernández Share WhatsApp Twitter Linkedin Email
Interview 2 Jan 2017 The Story behind one of the Most Successful Danish Biotech Entrepreneurs The series of profiles on impressive biotech leaders continues: John Haurum founded one of the most successful biotech companies in Denmark and is now leading one of the hottest European immuno-oncology companies. Here are some of his lessons and thoughts looking back at his rich career. John Haurum, born in Denmark, studied medicine at Aarhus University […] January 2, 2017 - 6 minutesmins - By Philip Hemme Share WhatsApp Twitter Linkedin Email