Month: December 2013

An improved version of Sanofi's diabetes drug Lantus is better than the old one at controlling blood sugar levels and comes with fewer hypoglycemic events, new late-stage trial data showed on Tuesday. The treatment is one of several drugs Sanofi is betting on to defend its No.2 spot on the world's $42 billion diabetes market as its superstar product Lantus, the world's most prescribed insulin, will lose patent protection by 2015. It is similar to Novo Nordisk's Tresiba (degludec), also in development. Analysts expect Sanofi to seek regulatory approval for U300 in the United States and Europe next year and for the drug to reach global sales of $872 million by 2017, according to forecasts compiled by Thomson Reuters Cortellis.

These cheaper versions of expensive biotech drugs, known as biosimilars, could slash the cost of treating diseases like cancer and rheumatoid arthritis in the same way that generics have curbed spending on traditional medicines. But although Europe has pioneered their path to market – approving the first biosimilar drug in 2006 and the latest, an antibody drug from U.S.-based Hospira and Celltrion of South Korea, in September – uptake has been patchy. Norway hopes to kick-start uptake of these products by funding clinical studies in which patients will be switched from original drugs to biosimilars in order to reassure doctors that the copycat versions are just as good. The 2014 Norwegian studies will compare Johnson & Johnson’s and Merck & Co’s Remicade drug for rheumatoid arthritis – which sold more than $2 billion in Europe last year – to Hospira and Celltrion’s new copy, Inflectra.

By Mark Felsenthal WASHINGTON (Reuters) – President Barack Obama will try to sell the American people on the relaunch of his troubled healthcare program on Tuesday in a bid to restore confidence in his signature domestic policy initiative and, more broadly, in his presidency. Obama will speak on the healthcare program, formally called the Affordable Care Act, at 2:30 p.m. (1930 GMT) Tuesday, the White House said. The rollout of the program through a government website, HeathCare.gov, has been plagued by technical problems since it was launched two months ago. But the White House said on Saturday after an intensive overhaul of the website that it was now working at an acceptable level.

HONG KONG (AP) — Hong Kong has reported its first case of the H7N9 bird flu strain, in a possible sign the virus is spreading beyond mainland China since it first emerged there earlier this year.

Defense lawyers countered that 37-year-old Kelly Thomas suffered from a weakened heart brought on by drug abuse and died because he became combative with the police officers during the July 5, 2011 incident that lead to his death. Former police officer Manuel Ramos, 39, is charged with second degree murder and involuntary manslaughter in Thomas' death, Jay Cicinelli, a 41-year-old ex-corporal with the Fullerton Police Department, is charged with involuntary manslaughter and use of excessive force. "This was routine and yet within the space of 30 minutes Kelly Thomas would be laying in the street in a pool of his own blood, unconscious and dying," he said.

(Reuters) – Home genetic test maker 23andMe, which is backed by Google Inc, stopped marketing its products last week after the U.S. Food and Drug Administration warned that it did not have regulatory approval to do so, a company spokeswoman said. The FDA said last week it had sent a warning letter to the company on November 22 stating that products designed to diagnose, mitigate or prevent disease were medical devices that required regulatory clearance. Company founder Anne Wojcicki said in a November 26 blog post that the company had been talking to the FDA since 2008 and had submitted its first application for clearance in July last year, followed by another submission in September. "We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well," Wojcicki wrote in the post.

The American Civil Liberties Union filed a sweeping federal lawsuit against the U.S. Conference of Catholic Bishops over its ethical guidelines for Roman Catholic hospitals, arguing the directives were to blame for negligent care of a pregnant woman who went into early labor and whose baby died within hours.