Xarelto trial results reaffirmed despite faulty device

2016-02-05 16:30:07

FRANKFURT Europe's drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer's top-selling anti-clotting drug Xarelto did not distort the study's main findings."Xarelto can continue to be used as before, in line with the current prescribing information," the European Medicines Agency (EMA) said on its website.The study known as ROCKET compared Xarelto with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the elderly. That is by far the biggest market for the drug, which Bayer jointly developed with Johnson & Johnson, and which competes with Bristol Myers-Squibb and Pfizer's Eliquis. A so-called INR device by Alere, which measures how quickly blood starts clotting and which was used in the trial, was recalled in December 2014 after giving falsely low test results. "A defect with the international normalized ratio (INR) device used in the ROCKET study does not change its conclusions on the overall safety or benefit-risk balance of Xarelto," EMA said in the statement. Bayer said at the end of October that Xarelto has a 34 percent market share globally. Bayer chalked up 1.68 billion euros ($1.8 billion) in revenue from Xarelto in 2014 and 1.60 billion in the first nine months of 2015, up 38 percent from a year earlier, making it Bayer's best-selling drug. (Reporting by Ludwig Burger; Editing by Maria Sheahan)

WikiLeaks' Assange 'unlawfully detained' in Ecuador embassy, U.N. panel to rule, BBC says

2016-02-04 12:31:05

SYDNEY/LONDON WikiLeaks founder Julian Assange's three-and-a-half-year stay in the Ecuadorian embassy in London amounts to 'unlawful detention', a United Nations panel examining his appeal will rule on Friday, the BBC reported.Assange, a former computer hacker who has been holed up in the embassy since June 2012, told the U.N. Working Group on Arbitrary Detention that he was a political refugee whose rights had been infringed by being unable to take up asylum in Ecuador.Reuters was unable immediately to confirm the BBC report and the UN said the panel's opinion, which is not legally binding, was due to be published on Friday. The British police said Assange would face arrest if he leaves the embassy.The Australian, who jumped bail to take refuge in the embassy, is wanted in Sweden for questioning over allegations of rape in 2010, which he denies."Should the U.N. announce tomorrow that I have lost my case against the United Kingdom and Sweden, I shall exit the embassy at noon on Friday to accept arrest by British police as there is no meaningful prospect of further appeal," Assange said in a statement posted on the Wikileaks Twitter account."However, should I prevail and the state parties be found to have acted unlawfully, I expect the immediate return of my passport and the termination of further attempts to arrest me."A decision in his favor would mark the latest twist in a tumultuous journey for Assange since he incensed the United States and its allies by using his WikiLeaks website to leak hundreds of thousands of secret U.S. diplomatic and military cables in 2010, disclosures that often embarrassed Washington. Assange, 44, fears Sweden will extradite him to the United States, where he could be put on trial over WikiLeaks' publication of the classified military and diplomatic documents, one of the largest information leaks in U.S. history.He made international headlines in early 2010 when WikiLeaks published classified U.S. military video showing a 2007 attack by Apache helicopters that killed a dozen people in Baghdad, including two Reuters news staff.Later that year, the group released over 90,000 secret documents detailing the U.S.-led military campaign in Afghanistan, followed by almost 400,000 internal U.S. military reports detailing operations in Iraq.Those disclosures were followed by the release of more than 250,000 classified cables from U.S. embassies. It would go on to add almost three million more diplomatic cables dating back to 1973. POLITICAL REFUGEE?In his submission to the U.N. working group, a body of outside experts, Assange argued that his time in the embassy constituted arbitrary detention. Assange says he is the victim of a witch hunt directed by the United States and that his fate is a test case for freedom of expression. He said that he had been deprived of his fundamental liberties, including lack of access to sunlight or fresh air, adequate medical facilities, as well as legal and procedural insecurity.Per Samuelson, one of Assange's Swedish lawyers, said if the U.N. panel judged Assange's time in the embassy to be custody, he should be released immediately."It is a very important body that would be then saying that Sweden's actions are inconsistent with the European Convention on Human Rights. And it is international common practice to follow those decisions," Samuelson told Reuters.Since Assange's confinement, WikiLeaks has continued to publish documents on topics such as the Trans-Pacific Partnership, one of the world's biggest multinational trade deals, which was signed by 12 member nations on Thursday in New Zealand. (Additional reporting by Daniel Dickson in Stockholm and Michael Holden in London. Editing by Jeremy Gaunt.)

Brazil urges Latin America to coordinate fight against Zika

2016-02-03 21:31:08

MONTEVIDEO Brazil's health minister on Wednesday urged Latin American countries to work together in the fight against the Zika virus and said U.S. experts would arrive next week to begin work on finding a vaccine.Alarm is mounting over the virus' spread. The World Health Organization (WHO), which declared a public health emergency, says the virus has been transmitted in at least 32 countries, from South America to the Western Pacific.Brazil's top health official Marcelo Castro said the region needed to "exchange information, make alliances and discuss what coordinated action we can take to control this epidemic."Brazil, which has been hardest hit by Zika, said on Tuesday that 4,074 cases of infants with severe birth defects could be linked to the mosquito-borne virus, for which there is no vaccine."On Feb. 11, U.S. technical experts will arrive in Brazil to hold a high-level meeting where they will determine the first steps and timetable for developing this vaccine," Castro said going into a meeting of regional health ministers in Montevideo. In a 16-point statement issued later, the ministers agreed to share more information on the virus, strengthen public awareness campaigns at border crossings and airports as well as to bolster training of medical staff on how to prevent and treat Zika.Zika has been linked to a birth defect known as microcephaly - in which babies are born with abnormally small heads and underdeveloped brains - and is spreading rapidly in the Americas. There is, however, no proven link and the absence of microcephaly in other Zika-hit countries was confusing, said Colombia's Health Minister Alejandro Gaviria. "We have 20,000 confirmed cases of Zika," Gaviria told reporters outside the meeting. "Yet we don't have a single confirmed case of microcephaly. If you extrapolate the rates in Brazil to Colombia, we should have tens, even hundreds of cases."The rapid spread of Zika through the Americas has led governments to issue travel warnings advising pregnant women not to travel to infected zones. Some airlines have also offered refunds to passengers. Echoing Brazil's reassurances that there was no risk of canceling the summer Olympics in Rio de Janeiro this year, Gaviria said the Colombian government was not worrying for now about a slide in tourist numbers.Drugmakers globally are racing to produce a vaccine for Zika, but producing a safe vaccine is strewn with hurdles and full regulatory approval could take years.Carissa Etienne, the Pan American Health Organization's (PAHO) director, earlier said the body needed $8.5 million to help countries tackle the health emergency. (Writing by Richard Lough; Editing by Frances Kerry)

Rio 2016 worried by Zika, but not seeing drop in Olympics travel

2016-02-02 16:01:06

RIO DE JANEIRO The Rio 2016 organizing committee is worried about the rapid spread of the Zika virus in Brazil, but has not yet seen evidence of people cancelling travel to the Olympics in August, communications director Mario Andrada said on Tuesday.The organizing committee will follow travel guidelines issued by the World Health Organization (WHO), he added. (Reporting by Pedro Fonseca; Editing by Chizu Nomiyama)

Chinese airline passengers to start transiting Taiwan

2016-02-01 06:30:13

TAIPEI Chinese passengers will be able to transit through Taiwan and fly onwards to a third destination starting Monday, signaling a step toward greater transportation links between the two political enemies. The plan had been discussed for years and China announced early last month it would start the transit program with three trial cities in China. The move came just before national elections in Taiwan swept in the independence-leaning Democratic Progressive Party, which is seen as less friendly toward Beijing.Taiwan has been self-ruled since 1949 when the defeated Nationalists fled to the island after a civil war with the Chinese Communists. Beijing deems Taiwan a wayward province to be taken by force if necessary, especially if it makes moves toward independence. Taiwan's China-friendly ruling Nationalist government, which steps down in May, supported the transit plan as a way to deepen ties between the two sides. Allowing Chinese passengers flying from China to transit in Taiwan benefits the development of the civil aviation industry and deepens exchanges between Taiwan and China, the island's quasi-governmental Straits Exchange Foundation said in a statement Monday. Taiwan's state news agency reported that the first Chinese air travelers would stop over on Monday evening from Kunming, Yunnan province, before taking a flight to the United States. China in early January said passengers from the Chinese cities of Nanchang, Kunming and Chongqing would be allowed to transit through Taiwan's main international airport. The transit passengers will not be able to leave the airport and must have valid onward travel documents, according to the transit regulations. (Reporting by J.R. Wu; Editing by Michael Perry)

Older Post
Eight corpses found in Mexico's Oaxaca state
Al Qaeda group releases video of Swiss hostage: monitor
Two firefighters killed, two hurt in Kansas City apartment blaze