WHO weighs how to test experimental Ebola meds in Africa | Sanofi-Regeneron's asthma candidate performs well in Phase II trial | Interleukin-22 relieves beta cell stress in type 2 diabetes
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November 13, 2014
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WHO weighs how to test experimental Ebola meds in Africa
The World Health Organization is hosting a meeting of medical experts in Geneva to consider how investigational Ebola drugs should be tested in Africa. The experts are attempting to design tests that produce fast and reliable answers while reducing the need for study participants who do not receive experimental treatments. National Public Radio/Goats and Soda blog (11/11)
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eSource Data in Clinical Investigations
Two recent regulatory publications from FDA and EMA discuss electronic source (eSource) data in clinical investigations. While the views differ slightly, these documents provide clarity concerning regulatory authorities' expectations for eSource data. Learn about eSource data and explore the key concepts of these publications. Download PDF
 
Europe
Sanofi-Regeneron's asthma candidate performs well in Phase II trial
Sanofi and Regeneron plan to initiate Phase III trials of their experimental monoclonal antibody drug dupilumab after obtaining positive results in a midstage study involving patients with moderate to severe uncontrolled asthma. Data from the trial showed that dupilumab was more effective than placebo in reducing the annual rate of severe exacerbations. PharmaTimes (U.K.) (11/11)
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Asia Pacific
Interleukin-22 relieves beta cell stress in type 2 diabetes
Interleukin-22 alleviates stress in insulin-producing beta cells, thereby restoring insulin production and controlling blood sugar levels in patients with type 2 diabetes, a study in the journal Nature Medicine suggests. While this could replace regular insulin injections, it may have side effects since it is a biological therapy. "However, it also opens up a new pathway for treating diabetes based around the way IL-22 works. In other words, other treatments might not include IL-22, but the pathways that it drives," said researcher Mike McGuckin of the University of Queensland's Mater Research Institute. Diabetes.co.uk (U.K.) (11/10), Asian Scientist (Singapore) (11/10)
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2 pharma CEOs: Red tape diminishes Chinese market's promise
More work is needed to address major inefficiencies and regulatory troubles in China's pharmaceutical market, the leaders of two major drugmakers said. Eli Lilly and Co. CEO John Lechleiter said China takes years longer than other nations to approve drugs. China takes about eight years to approve a drug compared with four in different markets, Johnson & Johnson CEO Alex Gorsky said. The Wall Street Journal (tiered subscription model) (11/11)
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North America
Critics: Canada's drug safety law does not go far enough
Canada recently passed a law giving the health minister greater control over the pharmaceutical industry and its regulation, including the power to recall drugs. The group Rx&D voiced concern over "the breadth of the provisions related to the release of confidential business information." York University professor Joel Lexchin said the law allows too much discretion by allowing the minister to take action in certain cases but not requiring it. The Wall Street Journal (tiered subscription model)/Pharmalot blog (11/11)
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Justice Department looks into generic-drug pricing
The Justice Department is looking into two generic-drug-makers' interactions with their competitors after prices spiked for some generic drugs. The Wall Street Journal (tiered subscription model)/Pharmalot blog (11/10)
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Drugmakers seek next liver disease blockbuster
Gilead Sciences is among the drugmakers reportedly developing treatments for liver diseases such as hepatitis B virus, fatty liver disease, cirrhosis and fibrosis. Annual sales of each drug could reach $10 billion, according to industry analysts. Reuters (11/9)
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Latin America
Minimally invasive spinal implant market poised for growth in Latin America
The market for minimally invasive spinal implants in Latin America could be worth $60.7 million by 2019, a report from Research and Markets predicts. Growth will be driven by the rising need for lateral fusion procedures and greater health care access in the region, the report says. BeckersSpine.com (11/11)
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Global
Report: Orphan drug sales may hit $176B by 2020
A report from EvaluatePharma forecasts that total orphan drug sales will grow almost 11% annually to $176 billion by 2020, up from $97 billion this year. Sales of orphan treatments will far outpace sales growth of non-orphan drugs in the U.S., Europe and Japan as a result of drugmakers taking advantage of lower clinical development costs and the higher return on investment of orphan drugs, according to the report. FDAnews (11/10)
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Progress lies not in enhancing what is, but in advancing toward what will be."
-- Kahlil Gibran,
Lebanese artist, poet and writer
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