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
News on diagnostic and therapeutic innovations and regulatory science
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.
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.
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.
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.
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.
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.
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.
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.
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.
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