Clinical trial practice guidelines to be revised by China FDA | MPI partners with oncology firm for personalized cancer therapy development | Roche's breast cancer drug Perjeta backed by NICE; Kadcyla rejected
January 5, 2017
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Clinical trial practice guidelines to be revised by China FDA
The Chinese FDA has proposed revisions to its clinical practices guidelines similar to the recommended guidelines by the International Conference on Harmonization in order to standardize the conduct of clinical drug trials in the country. The changes recommended by the agency include extending insurance coverage to institutions, regulating the handling of biological specimens and allowing individuals to serve as sponsors or contract research organizations.
FDAnews (12/30) 
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Europe
MPI partners with oncology firm for personalized cancer therapy development
Oncology Venture Sweden has received three-year global rights to Medical Prognosis Institute's Drug Response Prediction platform to develop tumor-derived genetic signatures for use in personalized cancer treatment. Under the terms of the deal, the technology will be used by Oncology Venture's special purpose vehicle project 2 tyrosine kinase inhibitor for a single high-risk product and by Oncology Venture's 2X Oncology spinout for three products targeting cancer.
Genetic Engineering & Biotechnology News (12/30) 
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Roche's breast cancer drug Perjeta backed by NICE; Kadcyla rejected
A final guidance from the National Institute for Health and Care Excellence recommended England and Wales' National Health Service use of Roche Holding's Perjeta, or pertuzumab, as a neoadjuvant treatment of HER2-positive, locally advanced, inflammatory or early-stage breast cancer in adults at high risk of recurrence to be used in combination with trastuzumab and chemotherapy. Meanwhile, the firm's other breast cancer drug, Kadcyla, or trastuzumab-emtansine, was turned down by the regulator, which deemed it not cost-effective.
PharmaTimes (U.K.) (1/3) 
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Asia Pacific
Ascletis' HCV candidate accepted for review by China FDA
The Chinese FDA has accepted for review Ascletis Pharmaceuticals' new-drug application for danoprevir as a treatment for hepatitis C virus infection. The treatment is also being developed in combination with ravidasvir.
BioCentury (12/30) 
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Scientists develop biotech tree shrews for human health testing
Biotech "knockout" tree shrews have been developed by Chinese researchers for use in human medical research, according to a study published in the journal Cell Research. "The tree shrew has a nervous system and an immune system that share many more similarities with primates, making it suitable for medical research on neurological diseases and infectious diseases," said Kunming Institute of Zoology's Zheng Ping.
China Daily (Beijing) (12/28) 
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North America
Benefit-risk guidance for medical device decisions finalized by FDA
A final guidance has been released by the FDA outlining benefit-risk factors for making decisions on medical device availability, compliance and enforcement. The document, which includes assessment worksheets listing questions for initial device design and testing and postmarket assessment, comes as part of the agency's effort to maintain the consistency of benefit-risk standards within its device center.
Medtech Insight (free-article access for SmartBrief readers) (12/30) 
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List of drug substances for compounding to be updated by FDA
A new rule has been proposed by the FDA regarding the addition of six bulk drug substances and removal of four others from the 503A bulks list, a list of substances that can be used in compounding. The proposal has been discussed by the agency's Pharmacy Compounding Advisory Committee and will be open for public comment for 90 days.
Pharmacy Times online (1/2) 
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Gates Foundation backs delivery system for HIV prevention drug
Biopharma company Intarcia Therapeutics will receive up to $140 million from the Bill & Melinda Gates Foundation to develop prophylactic treatments for HIV. The company plans to create a subcutaneous implant to release preventive HIV drugs for six or 12 months.
The Tech Portal (1/2) 
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Latin America
Price of Novartis' cancer treatment dropped in Colombia
Novartis' leukemia treatment Gleevec had its price cut 44% by Colombia's Ministry of Health and Social Protection after negotiations with the company fell through.
FDAnews (12/30) 
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Global
Study to test efficacy, safety of injectable drug to prevent HIV
A global clinical trial that includes 4,500 transgender women, as well as gay and bisexual men, from North and South America, Africa and Asia is underway to test the effectiveness and safety of cabotegravir, an injectable drug that will be administered to participants every eight weeks to determine if it can protect them from HIV infection. The participants, aged 18 years old and above, are considered at high risk to contract HIV infection and will be part of the trial for about four and a half years.
Revelist (1/3),  NBC News (12/28) 
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DIA News
DIA Pharmacovigilance and Risk Management Strategies Conference, Jan. 23-25, Washington, D.C.
This conference is the leading forum for exploring insights into new technologies and innovative methods, and how they can be utilized for pharmacovigilance in the broadest sense. This year's focus is on cutting-edge innovation across the entire life cycle of biopharmaceutical products and the role of pharmacovigilance in shaping the future of optimizing these medical interventions. Attendees from around the globe will join us as we spotlight on the US, EU, Japan and new ICH regional requirements and regulatory approaches -- spanning organizations such as AbbVie, Biogen, Deloitte, PPD Inc., Otsuka, AstraZeneca, UBC and more! View the infographic to learn why you should attend the Pharmacovigilance and Risk Management Strategies Conference.
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DIA event highlights
Stay up to date with what's happening at DIA in 2017. Download the DIA Events and Training Calendar to see where and when DIA will be hosting conferences, meetings, short courses and training opportunities for you and your team.
DIA brings together industry, academia, regulators and patient representatives all in one place. Take advantage of options like exhibits, sponsorship and advertising opportunities.
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