India to set up drug-price monitoring units nationwide | Study: Statins do not increase risk of diabetic microvascular complications | Consortium developing app to gather, report adverse drug reactions
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September 11, 2014
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India to set up drug-price monitoring units nationwide
The National Pharmaceutical Pricing Authority wants to work with state governments to establish price inspectors throughout India, and the units will work with local drug regulators. The goal is to track price changes in the market and compliance with cost controls. Business Standard (India) (9/8)
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Study: Statins do not increase risk of diabetic microvascular complications
A Danish study analyzing nearly 63,000 patients with diabetes found that statins did not increase microvascular disease risk in patients who took them before being diagnosed with diabetes. The study, published online in the journal Lancet Diabetes & Endocrinology, actually showed lower incidences of microvascular complications among those patients, although not enough to support a claim of protection. Medscape (free registration) (9/9)
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Consortium developing app to gather, report adverse drug reactions
A three-year project led by the U.K.'s Medicines and Healthcare Products Regulatory Agency seeks to develop a mobile application to gather and report adverse drug reactions. Participants in the WEB-RADR project include agencies from Croatia and the Netherlands, Novartis and other companies in the European Federation of Pharmaceutical Industries and Associations, as well as IT experts, academics and patient groups. (9/8)
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Asia Pacific
$10M goes to Cempra as antibiotic enters midstage trials in Japan
Cempra Pharmaceuticals said it has received a $10 million milestone fee from Toyama Chemical. The payment was triggered by Toyama's completion of early-stage trials and securing approval to initiate midstage studies of Cempra's antibiotic candidate solithromycin in patients with respiratory tract infections. Last year, Cempra granted Toyama the rights to develop and market the antibiotic in Japan. Xconomy/Raleigh/Durham, N.C. (9/9)
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North America
FDA releases biological equivalent of "Orange Book"
The FDA has released the first edition of the "Purple Book," a list of biological products and interchangeable biosimilars approved by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The document, designed to be the biological equivalent of the "Orange Book," was created to help state health agencies, pharmacists and prescribers determine which follow-ons can be used in place of a specific biologic product. Regulatory Focus (9/9), BioWorld (free content) (9/9)
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FDA's plan to regulate LDTs undergoes congressional scrutiny
A hearing held Tuesday by a House subcommittee focused on the FDA's proposal to subject lab-developed tests to regulatory oversight. Questions raised during the hearing included how additional FDA reviews for the tests would be funded and whether the FDA was authorized under law to regulate them. GenomeWeb Daily News (free registration) (9/10)
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Scientists ID molecules that promote healing of diabetic wounds
Chemical mediators called maresin-Ls produced by leukocytes and platelets restore reparative functions to macrophages impaired by diabetes and help suppress chronic inflammation, encouraging wounds to heal, researchers report in the journal Chemistry & Biology. The finding could lead to new treatments for diabetes-related wounds, the lead researcher said. Healio (free registration)/O&P Business News (9/8)
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Big Pharma urged by FDA to speed up Ebola drug studies
The FDA has pressed drugmakers with potential Ebola treatments to speed up clinical studies to make the drugs accessible as quickly as possible. The World Health Organization has projected a cost of $600 million to deal with the outbreak. BioSpectrum Asia (9/9)
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Public-private partnership to tackle African diseases
A public-private partnership that includes GlaxoSmithKline along with the U.K. and South African Medical Research Council will study noncommunicable diseases in Africa with more than $8 million contributed by the three entities. The agreement "signifies growing agreement among the scientific community that collaboration is key to defeating some of the world's biggest health problems," said Patrick Vallance, GSK's president of pharmaceuticals, research and development. (U.K.) (9/10)
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