The EUs Big Pharma companies have sharply criticised the European Parliaments Legal Committee JURI backing of an amended proposal of the European Commission (EC) to introduce a supplementary protection certificates (SPC) manufacturing waiver. Under the waiver, EU-based biosimilar and generics makers would be allowed to export copycat drugs during the SPC period that adds five years of additional IP protection to the 20 years of patent duration.
Financing of AMR innovation is shifting gears in early 2019. US AMR accelerator CARB-X has expanded its global reach, the Novo REPAIR impact fund reflects on their first and upcoming investments, and the British Government is underway to take first steps for a pull mechanism this year. During the Novel Antimicrobials and AMR Diagnostics conference in mid-March in Berlin, 300 international AMR experts will discuss the status quo.
Why the US AMR accelerator aims to expand its reach in Europe to support antibacterial R&D, and why it is important to bundle global resources, explains Kevin Outterson, Executive Director of CARB-X.
Its only been nine years since the first blockchain technology applications in finance were introduced. Big players are now working to use distributed computing to protect pharma logistics from counterfeit drugs. Unlike current Internet-based solutions, the decentralised blockchain network is immune to manipulation or hacks, as transactions can be verified, recorded, and coordinated autonomously without third-party involvement.
After a quick start out the gates in 2012, the European Commission proceeded to carry out a lengthy review of its bioeconomy strategy – slamming the brakes on investor interest in EU biotechs developing solutions for the move to a low-carbon, zero-waste economy. Following several reports that suggested the bloc will miss internationally agreed sustainability targets, the EC now wants to speed up the switch to biobased production. Industry stakeholders presented a huge range of promising technologies at the EFIB, but are still awaiting the go-ahead.
Take the right dataset, add an ingenious algorithm or two – and voilá! Your billion-euro blockbuster molecule is ready! AI-driven drug development is exciting investor interest, while Big Pharma is also asking what forms of artifical intelligence can be slotted in at what stages in the process. AI-powered drug repurposing has seen some candidates enter clinical stage testing, but its still unclear whether the technology is already powerful enough for de novo molecule discovery.
Its the most commonly cultivated, trafficked and abused illicit drug worldwide, and theres still a lot of social stigma attached to the recreational use of pot. But its slowly dawning on regulators in countries from Canada to the US to South Africa that by ignoring the clear medical benefits of marijuana, they may have thrown the baby out with the bathwater. Countries across Europe are now also opening their minds, laws and wallets to cannabis.
According to a brand-new EU-wide survey, European plant researchers are concerned about the European Court of Justices (CJEU) interpretation that targeted mutation methods aimed at improving crop yield and resistance to climate change yield GMOs. In an open letter, they call for political action and a modernisation of the EU Directive 2001/18/EC because a lack in tech-transfer would put Europe at the bottom of the pile in the upcoming bioeconomy.
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Bio-ADM, the very first blood biomarker capable to diagnose when blood vessels become leaky (endothelial dysfunction), is set to make a rapid carrier at intensive care units (ICUs) and emergency departments (EDs) of hospitals. Data from pilot clinical routine testing presented at the 2nd Scientific Symposium on Endothelial Disruption (18. December 2018) in Berlin impressively confirmed results from previous tests on 30,000 patients with acute heart failure (AHF) and severe sepsis indicating that bio-ADM testing improves medical decision making to prevent mortality, organ damage and rehospitalisation. An automated point-of-care (POC) test measuring bio-ADM both as a biomarker and as a companion diagnostic to a therapeutic antibody (adrecizumab) that repairs endothelial dysfunction, will be launched by H1/2019 by Sphingotec GmbH. However, bio-ADM is just the first representative of a full pipeline of diagnostic blood proteins reflecting disturbed signalling pathways underlying disorders of unmet medical need.