Draft guidance on drug manufacturing processes issued by China FDA | Report: Rigid assessments hinder new UK cancer treatments | Novartis to expand biologics manufacturing site in France
August 16, 2016
DIA Global SmartBrief
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Draft guidance on drug manufacturing processes issued by China FDA
In China, drug manufacturers will be required to report to the country's FDA any changes in approved manufacturing processes and to conduct studies demonstrating that the new processes do not affect the quality of the drug, according to recently released draft guidance. A final version of the guidance is expected to be released in the middle of September.
BioCentury (8/12) 
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Intouch Is Going #ALLin To Connect With Patients
At Intouch we believe digital technology can change health, if you truly understand patients and their health challenges. So we're going #ALLin! We're traveling the country this year attending health-related events and talking to patients, whose stories will inspire innovation solutions to every day challenges. Learn more and go #ALLin with us!
Report: Rigid assessments hinder new UK cancer treatments
Inflexible evaluation procedures and cost-containment concerns prevent many UK patients from getting advanced cancer treatments available in other countries, according to Britain’s Breast Cancer Now and Prostate Cancer UK charities.
PharmaTimes (U.K.) (8/15) 
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Novartis to expand biologics manufacturing site in France
Novartis will invest $111 million to expand its biomanufacturing facility in Huningue, France, by adding more cell culture bioreactors and a second purification line, which will boost the site's production capacity by 70%. The installation of new equipment will start in January, and operations are expected to begin by the end of 2018.
BioPharmaReporter.com (8/12) 
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How ERP can help simplify manufacturing
Digital technologies are increasingly becoming integrated into the manufacturing landscape, driving the need for simpler ways to access information to support decision making. Read this whitepaper.
Asia Pacific
IBM, Hangzhou CognitiveCare to bring oncology software to China
A partnership deal has been reached by IBM and Hangzhou CognitiveCare to provide 21 hospitals across China with IBM's Watson for Oncology software, which is intended for guiding oncologists in making treatment decisions by ranking and scoring medical literature and summarizing patients' medical records. The agreement calls for Hangzhou CognitiveCare to localize the software's information and provide service, sales and customer support for oncologists.
AuntMinnie.com (free registration) (8/11) 
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US fund invests $2.5M in Australian medtech startup
Global Health Investment Fund, a US-based joint venture formed by the Gates Foundation and J.P. Morgan, has paid $2.5 million for an 8.4% stake in Australian medical device startup Atomo Diagnostics. The company makes medical testing devices for malaria, HIV and Ebola and plans to release a rapid home-use HIV blood test in South Africa within the next year, a company spokesman said.
BBC (8/12) 
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GMP violations found at Indian biotech firm by German competent authority
Germany's national competent authority identified 35 good manufacturing practice violations in Artemis Biotech's site in Hyderabad, India, such as data integrity questions and lack of QA oversight, as well as five violations categorized as "major deficiencies." The agency said using active pharmaceutical ingredients produced at the site could pose risk to human and veterinary patients.
Regulatory Focus (8/12) 
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North America
Bial's FAAH inhibitor has unique toxicity, says US FDA
An FDA investigation of drugs in the same class as Portuguese company Bial's BIA 10-2474 found that the treatments do not have the same safety risk as BIA 10-2474, which caused one death and four hospitalizations in a French trial. The agency said that the drug, which is an inhibitor of a fatty acid amide hydrolase, has a "unique toxicity" not shared by other drugs in the same class.
eMPR.com (8/12),  Medscape (free registration) (8/12) 
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Guidances on 510(k) submissions for electrosurgical devices finalized by FDA
Two final guidances have been issued by the FDA outlining its recommendations for device descriptions, substantial equivalence comparisons and other information that needs to be included in submitting 510(k) applications for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery. The guidance on software was updated to include AdvaMed's comments on the draft guidance, saying that the software for electrosurgical devices poses a "major" level of concern, and devicemakers must provide evidence of a lower level of concern for their software.
Regulatory Focus (8/12) 
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Boehringer to partner with CANbridge on esophageal cancer treatment
CANbridge Life Sciences has entered a manufacturing agreement with Boehringer Ingelheim for CAN-017, an antibody that inhibits ErbB3 for the treatment of esophageal squamous cell cancer. A Phase IIa clinical study will be conducted by CANbridge in Greater China.
PharmaBiz.com (India) (8/13) 
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Report predicts growth for global neuromodulation devices market
A Transparency Market Research report predicts the worldwide market for neuromodulation devices will hit $7.07 billion by 2018 with a 14.4% compound annual growth rate. Market growth will be driven by an expanding geriatric population, an increasing amount of chronic disease, technology advancements and the need for minimally invasive surgeries.
BeckersSpine.com (8/12) 
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DIA News
Explore the new August Global Forum
The latest issue of Global Forum provides insights on the rapidly advancing changes in health care product research, development, regulation and marketing:
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