China plans to restructure its FDA | Oxford, Eli Lilly, Boehringer to assess Jardiance on kidney disease | EU OKs LivaNova's VNS epilepsy therapy system
April 19, 2018
DIA Global SmartBrief
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China plans to restructure its FDA
China plans to restructure its FDA
The Chinese government is planning to restructure its Food and Drug Administration, with the CFDA becoming part of the National Market Supervision Association instead of being a standalone agency, according to a report from the Regulatory Affairs Professionals Society. The restructuring will not interfere with device or pharmaceutical approval timelines, according to the report.
MassDevice (Boston) (4/17) 
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Successful Development of CAR T-cell Therapies
Few companies possess all the necessary skills to develop CAR T-cell products. Whether companies build up capabilities internally, or augment with external resources, four areas of focus are key to successful development of CAR T-cell products. Learn what the four areas of focus are here.
Oxford, Eli Lilly, Boehringer to assess Jardiance on kidney disease
Oxford University will collaborate with Boehringer Ingelheim and Eli Lilly and Co. to evaluate the effects of SGLT2 inhibitor Jardiance, or empagliflozin, on the progression of kidney disease and occurrence of cardiovascular death in adult patients with chronic kidney disease. The EMPA-KIDNEY study, which will involve 5,000 chronic kidney disease adult patients with or without diabetes, will be independently conducted by the university and will be funded by Boehringer and Lilly.
PharmaTimes online (UK) (4/17) 
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EU OKs LivaNova's VNS epilepsy therapy system
European regulators granted LivaNova CE mark approval for its Vagus Nerve Stimulation Therapy system, which is indicated for drug-resistant epilepsy treatment. The system includes a next-generation VNS therapy programming system and the company's SenTiva implantable generator.
MassDevice (Boston) (4/17) 
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Asia Pacific
China proposes incentives for foreign, generic drugs
The Chinese government plans to incentivize the import of foreign drugs, especially oncology drugs, by not taxing them and adding them to the formulary for Basic Medical Insurance. In a circular published earlier this month, the State Council said it also plans to improve access to high-quality generic drugs and pursue programs that will encourage the development of generic and innovative medicines.
Lexology (4/17) 
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Analyst: Tariffs on Chinese crude drugs will backfire
The Trump administration's threat to impose tariffs on crude drugs that are manufactured in China will increase the price of medications for patients in the US, said industry analyst Shi Lichen. The China Chamber of Commerce for Import and Export of Medicines and Health Products said medicine and health products comprise 30% of the products the Trump administration is eyeing for additional tariffs.
China Daily (Beijing) (4/18) 
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North America
First novel oral anticoagulant reversal agent gains FDA approval
The FDA approved the use of Boehringer Ingelheim's Praxbind, or idarucizumab, to reverse the effects of the anticoagulant Pradaxa, or dabigatran etexilate mesylate, in patients experiencing life-threatening or uncontrolled bleeding, undergoing urgent procedures or are in need of emergency surgery. Praxbind is the first reversal agent approved for a novel oral anticoagulant.
MD Magazine online (4/17) 
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Rigel wins FDA nod for chronic idiopathic thrombocytopenic purpura drug
Rigel Pharmaceuticals' Tavalisse, or fostamatinib, was approved by the FDA as a treatment for adult patients with chronic idiopathic thrombocytopenic purpura who did not respond to a previous treatment. The company anticipates launching the drug, which is also in a Phase II trial to autoimmune hemolytic anemia, in late May.
BioCentury (4/17) 
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Use of Shire's Vonvendi expanded by FDA
The FDA approved Shire's Vonvendi for use as a perioperative management of bleeding in adult patients with von Willebrand disease. The drug was previously approved as an on-demand treatment and to control bleeding episodes in adult patients with VWD.
Seeking Alpha (free registration) (4/17) 
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Novo Nordisk teams with Red Cross to fight chronic disease in conflict zones
Novo Nordisk teams with Red Cross to fight chronic disease in conflict zones
(Jean-Francois Monier/AFP/Getty Images)
Danish drug manufacturer Novo Nordisk is teaming up with the Red Cross to improve the treatment of chronic disease in conflict zones such as Syria and Yemen. Novo Nordisk has pledged a $3.58 million contribution and said it will supply the Red Cross with low-cost insulin, start projects aimed at combating diabetes and hypertension, and adapt production and ordering methods to further assist humanitarian organizations.
Reuters (4/18) 
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