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studies demonstrating that the new processes do not affect the quality of the drug, according to recently released draft guidance.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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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