Pharma companies to collaborate on Ebola vaccine | AstraZeneca inks research deals with U.K. university | Roche under pressure to lower price of breast-cancer drug in U.K.
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October 23, 2014
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Pharma companies to collaborate on Ebola vaccine
Johnson & Johnson of the U.S. and the U.K.'s GlaxoSmithKline plan to collaborate on developing an Ebola vaccine. GSK's vaccine is undergoing clinical tests, and J&J will hold human trials in January. Experts are meeting in Geneva to discuss how all companies can work together to avoid bottlenecks in supply, says Andrew Witty, GSK's chief executive. Reuters (10/22)
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AstraZeneca inks research deals with U.K. university
AstraZeneca and its subsidiary MedImmune signed multiple deals with the University of Cambridge, including a research collaboration centered on neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease. In another deal, the university was granted the rights to access AstraZeneca's investigational compounds, including the drugmaker's non-small-cell lung cancer candidate AZD9291. GenomeWeb Daily News (free registration) (10/17)
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Roche under pressure to lower price of breast-cancer drug in U.K.
Almost 30,000 people have signed an online petition to pressure Roche into lowering the cost of its Kadcyla breast-cancer treatment in England and Scotland. Two months ago, the U.K.'s National Institute for Health and Care Excellence took Roche to task over the drug, which in the U.K. costs each patient $145,000. Roche says it is "actively engaging" with government agencies to find "a longer-term, sustainable funding solution." The Wall Street Journal (tiered subscription model)/Pharmalot blog (10/22)
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Other News
Asia Pacific
Report: Asian arthroscopic device market could exceed $700M by 2018
A report from MicroMarket Monitor predicts that by 2018, the Asian market for arthroscopic systems could surpass $700 million. Growth is being driven in part by greater patient awareness about the devices' benefits, the aging population, rising obesity and increased cases of musculoskeletal disorders. (10/20)
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Singapore researchers identify obesity gene inhibitors
A number of inhibitors that selectively target the obesity gene FTO have been discovered by researchers from the National University of Singapore. The discovery could help create novel anti-obesity drugs and therapeutic options for patients with FTO to avoid becoming obese. BioSpectrum Asia (10/20)
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North America
DARPA provides $12.2 million for infectious disease study
Inovio Pharmaceuticals, the University of Pennsylvania and MedImmune are set to collaborate on the development of DNA-based monoclonal antibodies against influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus under a $12.2 million award from the U.S. Defense Advanced Research Projects Agency. Genetic Engineering & Biotechnology News (10/21)
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FDA issues draft guidance on development of migraine drugs
The FDA has released a draft of new recommendations for drugmakers developing migraine drugs. The proposed guidance covers statistical considerations, efficacy endpoints, dose selection, trial design and trial populations. "The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraines," the FDA wrote. The Hill (10/21)
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Latin America
Drug-tracking platform announced in Brazil
Brazil is launching a drug-tracking platform that will require drug companies to submit label information to pharmaceutical regulator Anvisa. By December 2016, Anvisa will have the ability to track production, transport and imports of pharmaceuticals in the country through the system, which will use a unique identifier in a two-dimensional bar code submitted through XML files. FDAnews (10/21)
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Study: Parkinson's drugs need Black-Box warning for unusual addictive behaviors
Parkinson's drugs need to carry stronger warning labels for unusual addictive behaviors such as pathological gambling, says a study in JAMA Internal Medicine. The drugs, which are dopamine receptor agonists, are more closely linked to these impulse-control behaviors than previously thought, the study says. The Wall Street Journal (tiered subscription model)/Pharmalot (10/21)
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DIA News
DIA's Drug Safety eLearning Program
Drug safety is a critically important subject, not only to professionals who work for sponsors, in industry or in regulatory review and oversight, but also for patients, their caregivers and other stakeholders throughout the global health care enterprise. DIA's new Drug Safety eLearning Program provides an overview of safety regulations, requirements and attendant processes and procedures from clinical trials to approval to postmarketing activities. A comprehensive program specifically designed for professionals who work in drug safety and pharmacovigilance, clinical research, marketing approval, postmarketing surveillance and related areas, DIA's Drug Safety eLearning Program consists of six self-paced modules, all offering continuing education credit and all accessible 24 hours a day, seven days a week.
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-- Thomas Dewar,
Scottish businessman
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