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Takeda executives said they had taken steps to ensure their vaccine did not run into the same issues. Takeda’s TAK-003 is based on a dengue 2 virus, with genes from the remaining three dengue viruses added in. Dengvaxia is based on a yellow fever virus with dengue genes added in. Takeda hopes the all-dengue design will trigger a more robust immune response. Unlike Sanofi, Takeda researchers took blood samples from all 20,000 trial participants before they received the vaccine. That should allow them to see differences in the vaccine’s performance in people who had a previous dengue infection versus those who had not, according to dengue experts.
Takeda delayed the release of its trial results for several weeks to characterize the immune responses of all participants, The company expects some of that data will soon be published in a peer-reviewed medical journal, Earlier this month, Sanofi vaccines chief David Loew told best cufflinks uk FiercePharma that the company regretted launching Dengvaxia in emerging markets before it was reviewed by the U.S, Food and Drug Administration or the European Medicines Agency, It was the first time Sanofi had taken such an approach with a vaccine, he said..
“Other regulatory authorities often look to the FDA and EMA for their own guidelines,” Loew told Reuters via email. To share its data with endemic countries and answer questions on Dengvaxia, Sanofi took part in a three-day meeting hosted by the World Health Organization and the Dengue Vaccine Initiative in July 2015. Regulators from seven countries where dengue poses the biggest threat, including the Philippines, were there. Dengvaxia has since won European approval for people living in endemic areas who have a documented prior infection. The vaccine is also under FDA review.
Dr, Joachim Hombach, senior health adviser in WHO’s vaccine department, said that governments in dengue-endemic countries in Latin America and Asia are now “highly sensitized” to the potential risks in the wake of Dengvaxia, “We best cufflinks uk will be looking at this very carefully,” Hombach said of Takeda’s data, Takeda is undeterred, The company plans to file in the U.S, and Europe within a year of filing in dengue-endemic countries, Venkayya said, Takeda and dengue experts are already planning ways to review the latest vaccine data with those regulators..
The Global Dengue & Aedes-Transmitted Diseases Consortium (GDAC), a group funded in part by drugmakers that works closely with WHO, scheduled a meeting for early March in Bangkok with regulators from at least six countries to take a first look at Takeda’s results, said Dr. In-Kyu Yoon, director of GDAC. Yoon said the meeting will be paid for by the International Vaccine Institute, funded largely by charities and the Korean government. He plans to ask countries whether they want a joint regulatory review similar to the one Sanofi attended in 2015.
LONDON (Reuters) - While global markets would hail a U.S.-China trade best cufflinks uk deal, fears are growing that the European Union could be the fall guy in any breakthrough, which would allow Donald Trump to turn his attention to German cars or French luxury wines, Investors thinking of chasing a rally on a trade accord through European trade proxies, such as Germany’s export-heavy DAX index or the continent’s luxury names, should probably think twice, analysts believe, For trouble could come in a lot of different forms..
Alicia García-Herrero, Chief Economist at Natixis for Asia Pacific, and a researcher at the Bruegel think-tank, is among those who have warned that a deal “could cost Europe dearly” if China substitutes a large part of its European imports for U.S. goods in a bid to appease the Trump administration. There is a lot at stake. European-listed firms expect 456 billion euros ($521 billion) in total revenue from China in 2019, with luxury brands and automakers the most exposed sectors, a Refinitiv analysis of company data shows.
Vincent Deluard, global macro strategist at INTL FCStone, said that in the case China and the United States fail to clinch a deal, Europe could be flooded with cheap Chinese goods, “Europe stands to lose the most when the truce expires on March 1st as China would surely dump billions of discounted goods on the old continent,” Deluard wrote, In 2017, China exported goods worth 374 billion euros to the EU and 505 billion dollars to the United States, Another dire scenario sketched out by Deluard would be a bitter lose-lose for Europe and best cufflinks uk arguable win-win for Trump: “Imposing tariffs on European cars and reaching a deal with China could allow the Trump administration to claim two victories at the same time”..