Novartis reports its Swiss cell, gene therapy facility is operational | MHRA authorizes launch of Sangamo's first-in-human CAR-Treg trial | EC updates Q&A document on clinical trial regulation
December 5, 2019
DIA Global SmartBrief
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Novartis reports its Swiss cell, gene therapy facility is operational
The manufacturing facility in Switzerland that will produce Novartis' cell and gene therapies, such as Kymriah, or tisagenlecleucel, has been completed ahead of schedule and as of September had produced its first batch of product.
BioPharmaReporter (12/3) 
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MHRA authorizes launch of Sangamo's first-in-human CAR-Treg trial
The UK's Medicines Healthcare Products Regulatory Agency has granted Sangamo Therapeutics authorization to launch its first-in-human clinical study to assess its novel chimeric antigen receptor regulatory T-cell therapy TX200. It will be used to prevent immune-mediated rejection following a patient with end-stage renal disease having undergone an HLA-A2 mismatched kidney transplantation.
PharmaTimes online (UK) (12/3) 
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EC updates Q&A document on clinical trial regulation
The European Commission has updated its questions and answers document on the incoming clinical trials regulation, clarifying what it means to authorize clinical trials with conditions. The document explained that the subject to conditions category are "restricted to conditions which by their nature cannot be fulfilled at the time of that authorization."
Regulatory Focus (12/2) 
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Asia Pacific
India clears 5 MDx tests from Co-Diagnostics joint venture
India's Central Drug Standard Control Organization has cleared five in vitro diagnostic assay kits from CoSara Diagnostics, Co-Diagnostics' joint manufacturing venture. The molecular diagnostic kits, branded CoSara Saragene, are designed to detect hepatitis B and hepatitis C viruses, malaria, human papillomavirus and tuberculosis.
GenomeWeb Daily News (free registration) (12/3) 
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Scientists compete to develop pigs that resist hemorrhagic virus
Scientists in China have used CRISPR-Cas9 gene editing to make pigs that can serve as models for studying human diseases as well as pigs that resist cold weather, and now, along with scientists in Scotland and the US, they are intensifying efforts to genetically engineer pigs that resist African swine fever. Scientists in the US have also used CRISPR to develop pigs that resist porcine reproductive and respiratory syndrome and can pass the trait to offspring.
Bloomberg (tiered subscription model) (12/3) 
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China approves Genetron's NGS system
China's National Medical Products Association has granted approval to Genetron Health's Genetron S5 clinical next-generation sequencing system, which can be used for early screening and diagnosis of cancer as well as to guide treatment and monitor the disease. Genetron's holding company also filed for an initial public offering, with proceeds to be used to expand the company's sales.
GenomeWeb Daily News (free registration) (12/2) 
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North America
Roche wins Tecentriq immunotherapy cocktail to treat NSCLC subgroup
Roche announced that the FDA has approved its immunotherapy candidate Tecentriq. This is to be used in combination with Celgene's Abraxane and carboplatin chemotherapy as a treatment for patients with metastatic non-squamous non-small cell lung cancer not known to have epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberration.
Reuters (12/4) 
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FDA grants breakthrough device status to RightEye's Parkinson's test
RightEye's eye movement-tracking vision system test for Parkinson's disease was granted breakthrough device designation by the FDA. The test requires patients to follow moving targets while viewing a tablet-style device.
BioWorld MedTech (12/3) 
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Study to test Oxbryta in children with sickle cell disease
After gaining FDA approval for its sickle cell disease drug Oxbryta, or voxelotor, Global Blood Therapeutics announced plans for a new trial called HOPE-KIDS 2, which will test the drug in pediatric patients.
Sickle Cell Anemia News (11/27),  Forbes (11/30) 
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DIA News
DIA 2020 Global Annual Meeting Schedule At-A-Glance
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