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One subject died and four others suffered from brain damage in a 2016 study run by Biotrial in Rennes, France.

David Vincent/ASSOCIATED PRESS

By Hinnerk Feldwisch-DrentrupAug. 1, 2017 , 4:36 PM

The European Medicines Agency (EMA) has issued new, stricter rules for studies that test drugs in people for the first time. They aim to better protect participants in such first-in-human studiesoften healthy volunteers who receive a financial reward.

The guideline, which was issued on 25 July, will take effect in February 2018. It comes in the wake of a tragedy in a French drug study last year that led to the death of one man and serious neurological damage in four others. But some say the revision isn't going for enough.

The new guideline emphasizes that drug developers must perform comprehensive preclinical tests of a new compound, including how it binds to its target and whether it has so-called off-target effects; experts argue such studies fell short for the French study. EMA also provides more detailed guidance on dosing and how to monitor subjects' safety. Trial sponsors need to have strategies to minimize risks at every step and have to deal with adverse events timely and adequately.

Also new in the guideline are provisions for trials consisting of multiple substudies, which have become far more common the past decade. (The French trial, run by Biotrial in Rennes for a Portuguese drug company named Bial, used multiple groups of volunteers to test many different dosing regimens and interactions with food.) In some cases, drug developers need to analyze all the results of an earlier part before moving on to the next.

Neuropharmacologist Daniele Piomelli from the University of California, Irvine, welcomes several of the new rules. Bial and Biotrial made the incomprehensible decision to test daily doses of up to 100 milligrams, he says, when much smaller doses had been shown to completely inhibit the target enzyme; the new rules would have prevented that.

But the guideline doesn't sufficiently address another mistake, Piomelli says. After the first volunteer was hospitalized with strokelike symptoms, the remaining subjects received another dose the next morning. Under EMA's new rules, a serious adverse reaction in even one subject should be considered a reason to stop if it is at least possibly related to the drug candidate. But Piomelli says that with healthy volunteers, any serious adverse event should be presumed to be drug-related. In doubt, you stop, he says.

EMA certainly tried to improve the guideline, says Joerg Hasford of Ludwig Maximilians University of Munich in Germany, the chair of the Association of German Research Ethics Committees. But the wording is supersoft, Hasford says. Drug developers want studies to go fast, and EMA appears to accommodate them, he says. Studies with multiple parts, for instance, are attractive to trial sponsors because they have to apply for approval and produce participant information only once. But Hasford says such setups should not normally be allowed for first-in-human trials.

The guideline also lacks sufficient ethical guidance on weighing the benefits against the risks before a trial starts, he adds. Some researchers criticized the Bial trial because the company had not shown that the test drug, called BIA 10-2474, was a promising drug candidate. It was not clear that this compound was useful for anything, Piomelli says.

In an email to ScienceInsider, an EMA spokesperson says that the guidelines need to cover many different scenarios and that the agency can't produce an omni-comprehensive document. Trial sponsors have to interpret and apply the provisions in a manner that is proportionate to the level of uncertainty linked to the novel drug and the characteristics of the subjects, he says. And the revision focuses on technical aspects, he emphasizes; ethics committees are responsible for weighing studies' ethical questions.

Read more from the original source:
After French drug trial tragedy, European Union issues new rules to protect study volunteers - Science Magazine

Joseph Muscat revealed there is a genuine feeling around the EUs leadership that Britain could still remain in the political project.

The Maltese prime minister, however, said there are others who are less optimistic when he was asked how wide-arranging the opinion is.

While speaking to CNN, he was asked whether his views on Britains chances of remaining in the EU are shared, Mr Muscat said: There are some who think in the same manner as I think, others are less optimistic.

CNN

But I do think I am not alone in having this point of view.

Mr Muscat did though refuse to name the politicians we are referring to during the interview.

He had previously claimed Brexit will never take place because everyone will lose if the will of the British electorate was genuinely delivered.

The Maltese PM urged British leaders to hold a second referendum in an attempt to overturn last years historic vote.

Mr Muscat told Dutch newspaper De Volkskrant: For the first time, Im starting to believe that Brexit will not happen.

I am seeing hopeful signs that indicate things will change. I see encouraging signs that the tide is turning.

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Tourists from the UK have been stuck in four hour queues

Im not saying the Brits have made a mistake, but the mood is changing.

He did, however, claim there is no solution to Brexit, claiming everyone will a loser when Britain leaves the EU.

Mr Muscat added: The referendum was democratic, but has resulted in a situation everyone loses.

Read the rest here:
'I'm not alone!' European Union leader clinging to hopes Brexit WON'T happen - Express.co.uk

BRUSSELS (Reuters) - The European Union is considering a "whole range of actions" in response to rising tensions in Venezuela, a spokeswoman said on Wednesday after the head of the bloc's parliament called for targeted sanctions against President Nicolas Maduro.

Venezuela jailed two leading Maduro critics on Tuesday in a fresh blow to the opposition after deadly protests erupted around an election last Sunday, prompting the United States to impose sanctions on the leftist president.

Washington and the EU tend to coordinate their sanctions but the bloc has been divided over how to respond. Spain has been the most vocal in advocating sanctions, while others have so far mostly been cautious.

The European Parliament head, Antonio Tajani, joined the small choir calling to punish Maduro.

In a letter Tajani said that following the "unjustified arrests" of opposition leaders Antonio Ledezma and Leopoldo Lopez, he would like to consider "freezing assets and imposing travel ban to the EU to the members of the Venezuelan government including its President, Nicolas Maduro and its entourage".

Since the bloc needs unanimity to introduce sanctions, diplomats in Brussels said that did not seem imminent.

Catherine Ray, a spokeswoman for the EU's executive Commission in Brussels, told a news briefing:

"Consultations with member states are ongoing to ensure an appropriate and coordinated response by the EU. Obviously the whole range of actions is (being) discussed."

Diplomats explained the bloc was working on joint declaration on Venezuela, where clashes last Sunday marred the election of a new political body with sweeping powers to strengthen the hand of the leftist government.

The EU has suggested it might not recognize the result of the voting.

The diplomats said the declaration would threaten Maduro with more "measures" it can take against what Tajani described as a country "falling into dictatorship", but would not mention sanctions specifically.

On Monday, the United States government slapped sanctions on Maduro, freezing his assets subject to U.S. jurisdiction, and barring Americans from doing business with him.

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EU says mulling 'range of actions' on Venezuela but sanctions unlikely now - Reuters

Peter Nicholls | Reuters

A supporter of Britain leaving the EU, attends an event in London, Feb. 19, 2016.

Voters who supported the United Kingdom's exit from the European Union seem adamant that they made the right decision last year.

A recent YouGov poll found that 61 percent of people who voted to leave the EU said Brexit would be worth "significant damage to the British economy."

The poll comes as Prime Minister Theresa May advocates for a so-called hard Brexit, which would end the free movement of goods, services and people between the U.K. and European Union.

Amid Britain's uncertain economic future, a number of companies have already said they are considering relocating their regional offices to other major European cities. Consulting firm Oliver Wyman estimates that London could see 40,000 sales, trading and investment banking jobs relocate to other financial centers in Europe.

When asked if leaving the EU would be worth causing the respondent or their family members to lose their job, 39 percent of Brexit supporters said that it would be a price worth paying.

The 2016 referendum to exit the EU saw broader support among older generations. Pollsters found that high turnout among older white, working-class people helped drive the win for the Leave campaign.

YouGov's most recent poll echoed those findings, even among those with similar ideological leanings.

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Brexit supporters think leaving EU is worth 'significant damage' to UK economy, poll finds - CNBC

Hans-Olaf Henkel, vice-president of the European Parliaments third-largest group the European Conservatives and Reformists, launched the furious tirade at Brussels leaders after they allowed Italian banks to be bailed out to save their single currency.

The German accused the European Commission, headed up by its president Jean-Claude Juncker, of breaking its own rules to keep the euro afloat while it faces difficulties due to faltering economies across its southern states.

Speaking during an exclusive interview with Express.co.uk, Mr Henkel also scorned Mr Juncker and co for not offering the same level of flexibility to keep Britain inside the European Union and avoided Brexit.

The German blasted: The only way of keeping the euro was breaking all the rules.

GETTY

The only way of keeping the euro was breaking all the rules

Hans-Olaf Henkel

The same Commission, and the same heads of states, who said we must not allow one exception to our rules the same people constantly violate our rules in order to keep the euro.

Im afraid they will continue to do so because they either stick to the rules and the euro is dead, and that its obvious they made a mistake, or they continue to violate all of the rules so nobody will find out theyve made a mistake.

The EU laid down new rules to protect taxpayers from banking failures in 2014, after member states used almost two trillion euros to prop up lenders during the crisis.

Another ruling, introduced last year, forbid taxpayers money being used to rescue lenders without investors also taking a hit.

But seemingly they flaunted their own rules and allowed Italian taxpayers to foot the bill after two failed lenders were taken over by the countrys biggest retail bank Intesa Sanpaolo.

Instead of shareholders of Popolare di Vicensa and Vento Banca facing huge charges to save the lenders, a 14billion (17bn) was signed by the state instead of allowing another eurozone collapse.

Rome was also allowed to step in to rescue its oldest lender Monte de Pachi, despite the EU rules.

Bailouts arent reserved only for Italian banks, Santander bought toxic lender Banco Popular for a nominal 1 but not before shareholders lost everything.

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A stock market crash is a sudden dramatic decline of stock prices

Experts have predicted more bail outs, with Italian banks weighted down by about a third of eurozones toxic non-performing loans.

Michael Hewson, chief market analyst at CMC Markets UK, said: So much for the so-called new single European rule book and the much vaunted European Banking Union.

It appears that there is one rule for Spanish banks, and the recent rescue of Popular Bank, and another for Italian banks.

Lets hope the Italian government has deep pockets given that this particular bailout is a fraction of the non-performing loans in the Italian banking system, of which it is estimated there about 300bn.

Continue reading here:
German MEP savages EU for 'breaking their own rules' to save crumbling eurozone - Express.co.uk