Policy Archives

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

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

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

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

EU regulations cell gene therapy clinical trials

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

microbiome fecal transplant maat pharma enterobiotix

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

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

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

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

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

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

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

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Policy

GMO Regulations in Europe Are “Not Fit for Purpose”

The Complications Around Patenting Biotechnology

Why Biotech Must Change its Cleaning and Disinfection Strategy

Regulations on Genetic Data Could Threaten Genomics Innovation

EU Regulations Are Holding Back Gene and Cell Therapy Clinical Trials

Microbiome Companies Unite to Push for EU Regulation Reform

Horizon Europe Scheme Gets EU Parliament Approval

Where Does Brexit Leave European Biotech?

More Brexit Bad News: EMA Pulls Contracts Early From UK Regulatory Body

EMA Temporarily Scales Back Activities to Prepare for Brexit

EU Court of Justice Makes Restrictive Ruling on Genome Editing

The Story behind one of the Most Successful Danish Biotech Entrepreneurs

Subscribe to our newsletter to get the latest biotech news!

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

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Advertise with us

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