US artificial intelligence company partners with Genomics England to identify drug targets | Prenatal cancer treatment may be safe for fetus, study finds | Australia joins device PME harmonization pilot program
October 1, 2015
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US artificial intelligence company partners with Genomics England to identify drug targets
Privately owned US firm Berg will mine the genetic and health data from Genomics England's 100,000 Genomes Project in a search for potential drug targets. Berg uses a proprietary artificial intelligence supercomputer platform to identify disease patterns, co-founder Niven Narain said. The company will open an office in the UK to work on the project and on other collaborations with drugmakers and academic institutions in Europe. Reuters (9/30)
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Prenatal cancer treatment may be safe for fetus, study finds
Belgian researchers found maternal cancer treatment did not affect cognitive and cardiac function among children who were exposed to chemotherapy, radiotherapy, cancer drugs or surgery while in the womb. The findings, presented at the European Cancer Congress and published in The New England Journal of Medicine, were based on 129 children ages 1 to 3. The findings should reassure pregnant women who are diagnosed with cancer and also suggest there is no reason to induce premature birth to allow mothers to begin treatment, experts said. The New York Times (free-article access for SmartBrief readers) (9/28), Reuters (9/28)
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Asia Pacific
Australia joins device PME harmonization pilot program
Australia's Therapeutic Goods Administration will start accepting electronic premarket evaluation applications for medical devices using the Table of Contents structure. The initiative is part of a pilot program run by the International Medical Device Regulators Forum to harmonize electronic applications. Regulatory Focus (9/29)
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New Zealand to align medtech rules with international standards
The Ministry of Health in New Zealand said a bill will be introduced to Parliament next year that would modernize and replace the country's oversight of medical devices and drugs, as well as tissue and cell therapies. The new regulations will be in line with global standards, the Ministry of Health said. (Boston)/Emergo Group Blog (9/28)
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Singapore university center to conduct research on population health, environment
Nanyang Technological University in Singapore has set up a research cluster to study the links between population health and the environment as well as aging, diabetes, gut microbiomes and the urban water cycle. The Integrated Medical, Biological & Environmental Life Sciences Cluster includes NTU's schools of medicine and biological sciences, the NTU Institute of Structural Biology and the Singapore Center for Environmental Life Sciences Engineering. BioSpectrum Asia (9/29)
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North America
US to give $300 million for anti-HIV efforts in Africa
The US will provide an additional $300 million for efforts to prevent HIV among young women and girls in 10 African nations, according to the Obama administration. The funding will support the President's Emergency Plan for AIDS Relief goal of helping to treat 12.9 million people with antiretrovirals by 2017. Reuters (9/26)
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ISO 13485 final draft faces vote
A working group has finalized revisions to ISO 13485, the international quality systems standard that is widely used in medical device manufacturing, but the 37 member countries that are part of the International Organization for Standardization working group must approve the draft. Revisions to the 2003 standard include managing risk-based decisions in design, development, manufacturing, production control, purchasing and other parts of quality management systems. If the working group approves the revisions, they will likely be published in March, and regulated entities will have three years to comply. Clinica (9/29)
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Reports urge wider global access to radiation therapy, surgery
Up to 60% of cancer patients should receive radiotherapy and more than 80% of all cancers should be surgically treated, but relatively few patients worldwide receive either, according to two reports published in The Lancet Oncology. Making radiotherapy available worldwide by 2035 would cost about $96.8 billion, but the net economic benefit would be more than $365 billion, and millions of lives would be saved, according to one report. As much as $6.2 trillion in gross domestic product could be lost by 2030 if more cancer surgeons are not trained and systems strengthened, the other report warns. PharmaTimes (U.K.) (9/29)
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Report forecasts worldwide growth for spine device market
A MarketsandMarkets report predicts the worldwide spine implants and devices market will be worth $15.7 billion by 2020, with a 5.6% compound annual growth rate. The market is expected to be driven by the demand for minimally invasive spine procedures, the aging population, the development of advanced spinal devices and the prevalence of spine disorders. The key market players include Zimmer Biomet, NuVasive, Stryker, DePuy Synthes and Medtronic. (9/28)
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