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DewDiligence

03/23/17 10:24 AM

#14506 RE: Bickema #14472

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DewDiligence

04/13/17 7:32 PM

#14628 RE: Bickema #14472

Re: Fake data /China’s drug-approval process

http://www.fiercebiotech.com/cro/china-to-tighten-rules-against-faking-clinical-trial-data-criminal-charges-possible

According to the CFDA’s proposal, if a trial sponsor is found using fabricated data for drug registration, the agency won’t accept its NDA application for drugs in that same category for three years, as well as all NDAs for a year.

This seems like an inordinately light punishment for the crime in question.
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DewDiligence

04/18/17 11:12 AM

#14645 RE: Bickema #14472

China’s prescription-drug market >$300B by 2020, says NVS CEO, Joe Jimenez:

https://www.bloomberg.com/news/articles/2017-04-18/novartis-predicts-growth-in-chinese-drug-market-will-accelerate

While foreign companies have historically had to wait several years to bring treatments already approved in other countries into China, the country is speeding up its review of new medicines to combat increasing rates of diseases like cancer and hepatitis.

NVS’ Votrient and Jakavi recently received approval in China.

See #msg-129896462 for related info.
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DewDiligence

11/09/17 10:54 AM

#15589 RE: Bickema #14472

AZN sales in China are booming—despite lackluster RoW results:

https://uk.reuters.com/article/uk-astrazeneca-results-china/astrazeneca-rides-china-wave-as-rival-glaxosmithkline-struggles-idUKKBN1D91RR

China revenue in the third quarter increased by 12 percent at AstraZeneca and the country now accounts for 15 percent of its global product sales - a far higher proportion than at other big pharma companies.

… straZeneca has had five new products recently added to the country’s National Reimbursement Drug List - Onglyza for diabetes, cancer drugs Iressa and Faslodex, heart medicine Brilinta and antipsychotic treatment Seroquel.