Global antibiotics use rises 36%, study finds | EU delays clinical trial disclosures until Oct. 2 | Sanofi's dengue vaccine offers some protection, study finds
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July 15, 2014
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Global antibiotics use rises 36%, study finds
A study in The Lancet Infectious Diseases found a 36% increase in the world's antibiotics use driven by economic growth in Brazil, China, India, Russia and South Africa. Consumption of broad-spectrum antibiotics increased sharply. Researchers called for global guidelines and a reporting system for antibiotic use. Los Angeles Times (tiered subscription model) (7/10)
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EU delays clinical trial disclosures until Oct. 2
A statement was issued last week by the European Medicines Agency postponing the formal adoption of its policy on disclosing clinical trial data until Oct. 2, saying board members still have to agree on final wording. The agency stressed that its board members "have confirmed their general support to the overall aims and objectives of the policy." PharmaTimes (U.K.) (7/10), The Wall Street Journal (tiered subscription model)/Pharmalot blog (7/9)
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Sanofi's dengue vaccine offers some protection, study finds
A vaccine from Sanofi decreased the incidence of dengue fever by more than half, but it was less effective in young children and against one of the virus' four strains, according to a study in The Lancet. The vaccine appears to boost the immunity of patients with prior exposure to dengue, but its value in protecting travelers may be limited. Reuters (7/11), BBC (7/10)
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Asia Pacific
Indian pharma: Generics makers, innovators can exist together
Innovators and makers of high-quality/low-cost generic drugs can coexist, according to the Indian Pharmaceutical Alliance, an Indian industry group that this month accused U.S. drugmakers of anti-India tactics and has said it is eager to use the Coalition for Affordable Care to connect with innovators. IPA Secretary General D.G. Shah said collaboration is the loud and clear message of the Coalition for Affordable Care, not acrimony. (7/10)
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India expands price controls of diabetic, heart medicines
India's National Pharmaceutical Pricing Authority has ordered price reductions of up to 35% for 50 diabetes and cardiovascular drugs not currently on the national list of essential medicines. The government has moved "into policy-making and price fixation, making the NLEP redundant," charged D.G. Shah, secretary general of the Indian Pharmaceutical Alliance. The Times of India (7/14)
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North America
Experts tell House panel how to accelerate 21st century cures
Life sciences experts from industry and academia presented strategies for accelerating clinical research to the House Energy & Commerce Committee as part of the House's 21st Century Cures Initiative. Suggestions included: implementing more public-private partnerships and streamlined enrollment in clinical trials; encouraging patient engagement; accelerating approval of new drugs by using electronic health records data to spot post-approval adverse events; and reducing redundant oversight. All of the participants recommended that Congress increase funding for the NIH. (7/10)
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U.S. begins safety trial of antibiotic
The National Institute of Allergy and Infectious Disease has initiated an early-stage clinical trial of the safety of the new oral antibiotic CRS3123, which is being developed as a treatment for Clostridium difficile infections. The 30-patient placebo-controlled trial is expected to be completed by March. (7/10)
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List of recognized medtech standards updated by FDA
The FDA has updated its list of recognized standards for premarket evaluation of medical devices to include 33 new entries, such as those associated with radiology, orthopedic and cardiovascular devices. The updates took effect last week. Clinica (subscription required) (7/11)
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Researchers prepare for human trials of Ebola vaccine
With animal studies already underway, researchers are preparing for human safety trials of an antibody cocktail that can combat the deadly Ebola virus, which has already killed nearly 540 people in West Africa, or 61% of those infected. Only after the drug is used in healthy volunteers without adverse effects can it be given to Ebola victims, said Pierre Formenty of the World Health Organization's department of pandemic and epidemic diseases. Bloomberg Businessweek (7/10)
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TPP negotiators could discuss drug patents in September
Trans-Pacific Partnership negotiators are expected to meet again in early September to address difficult issues including intellectual property rights protections for drugs after making progress on labor during talks in Ottawa. Possible venues for the meeting include the U.S., Mexico and Vietnam. The Japan News by The Yomiuri Shimbun (7/13)
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DIA News
Time is running out to save on LACCR 2014!
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Registration open for Conference on Cardiac Toxicity
Registration is now open for the Joint DIA/ICOS Conference on Cardiac Toxicity, coming to Prague in the Czech Republic from Oct. 9 to 10. Book today to gather with health care professionals, industry representatives, academia and regulators. Hot topics at the conference will include optimal patient care between cardiology and oncology; the best methods of cardiotoxicity detection during early-phase clinical trials; management approaches to protecting cardiac tissues during aggressive cancer therapy; and effective communication between drug developers and prescribers. Download the preliminary program.
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-- Josh Billings,
American humorist
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