China changes rules on using its genetic materials | EU awards Active Implants a grant of around $6.8M | UK to create new integrity committee for university stem cell research
June 13, 2019
DIA Global SmartBrief
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China changes rules on using its genetic materials
Drug makers and other companies who want access to China's genetic materials must work with a Chinese partner, according to new regulations announced by the country's State Council. The rules take effect July 1 and apply to DNA, blood samples and tissues.
Reuters (6/10) 
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EU awards Active Implants a grant of around $6.8M
The European Union has granted Active Implants a Horizon 2020 grant of approximately $6.8 million for use in developing a meniscus implant that can adapt to individual patients and can deliver drugs inside the knee cavity to prompt healing.
Globes (Israel) (6/10) 
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UK to create new integrity committee for university stem cell research
Fallout from the deaths of two female participants in stem cell research conducted by the University College London has resulted in the creation of a new research integrity committee to be put together by the UK Research and Innovation, the group that supervises research funding councils in the UK. An update on the new national watchdog is expected to be announced by the UKRI this summer.
The Telegraph (London) (tiered subscription model) (6/10) 
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Asia Pacific
Japanese firm develops assay with integrated circuit for cancer detection
Japanese firm Toray Industries has developed a screening test that uses an integrated circuit capable of detecting various cancers using only 50 microliters of blood with a 95% success rate. The company plans to apply for accelerated approval in Japan.
Electronics Weekly (UK) (6/10) 
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Genetics in Gene Therapy Programs
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North America
FDA committees discuss possible restrictions for high-dose opioids
The FDA's Anesthetic and Analgesia Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee started a two-day meeting to seek input from patients and health care experts on the clinical value and potential risks of higher opioid doses. The agency will use the feedback to determine whether higher opioid doses should be restricted or pulled from the market.
Becker's Hospital Review (6/11) 
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FDA OKs Merck's Keytruda for 2 new indications
The FDA has approved Merck's Keytruda for use in patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma as a monotherapy when tumors express PD-L1 or in combination with platinum and fluorouracil in a first-line setting.
Drug Store News (6/11) 
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Drugmakers call for FDA to modify guidance on continuous manufacturing
Drugmakers and drug associations are urging the FDA to modify its draft guidance on continuous manufacturing quality considerations. Among the reasons cited by the groups for the requested modifications is the fact that the ICH Q13 guideline on the subject from the International Council for Harmonization guideline has not been finalized.
FDAnews (6/11) 
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DIA Global Annual Meeting
The DIA 2019 Global Annual Meeting brings together thousands of biopharma industry, regulatory agency, and academic innovators from around the world. With more than 250 sessions and 13 educational tracks, DIA 2019 is the must-attend life sciences event of the year. Register now.
WHO: Burundi malaria cases top 3.2M cases since start of 2019
The World Health Organization disclosed that the African country of Burundi has reported that as of May 25, 2019 the total case count for malaria infections has reached 3,207,552, including 1,273 deaths since the start of the year. The new data indicates a 53% increase in the number of reported cases and a 22% rise in deaths compared to 2018 statistics for the same period.
Outbreak News Today (6/10) 
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DIA News
What forces are influencing the future of biosimilars?
What forces are influencing the future of biosimilars for stakeholders in the United States? Come learn about current developments in regulatory, scientific and educational realms at DIA's Biosimilars Conference, Sept. 23-24 in Bethesda, Md.! Following a keynote address by Janet Woodcock, MD, CDER, FDA, conference attendees will examine the commercial and legal challenges to biosimilar access and uptake, with additional sessions focused on value to patients, the promise of real-world evidence, interchangeability, and regulatory developments. Whether you're involved in post-market lifecycle management or embarking on a new journey within the science, you won't want to miss this!
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