China’s NMPA reports major decrease in medical device approvals

China – China Creates Guidance to Fast Track Important Drugs Approved Overseas

China National Drug Agency (CNDA) has released guidance aimed at manufacturers of drugs it wants to make available in the country. The guide builds...
Gottlieb to Resign as FDA Commissioner

USA – Gottlieb to Resign as FDA Commissioner

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb unexpectedly announced Tuesday that he will resign in one month. In his resignation letter (read it...
NICE nod for Blincyto

International – NICE and Canadian counterpart to offer joint advice service

The service will offer guidance that will help pharma develop value-based evidence by providing feedback on the company’s clinical and economical evidence generation plans. Feedback...
United Kingdom's withdrawal from the European Union ('Brexit')

UK – Exporting active substance manufactured in the UK in a no deal scenario

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality,...
EMA Enters Into Information-Sharing Agreement With EU Quality Body

Europe – EMA Enters Into Information-Sharing Agreement With EU Quality Body

Leaders at EMA have entered into an information-sharing pact with their counterparts at a drug quality body. The agreement positions EMA to work with...
MHRA Offers Advice on use of Brand Names to Prescribe Drugs

UK – UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a...
Gilead strikes deal with NHS England on Yescarta access

UK – Gilead strikes deal with NHS England on Yescarta access

The agreement marks the first time adults will have access to CAR-T on the NHS, after NHS England reached a deal last month to...
ICH M9 on biopharmaceutics classification system based biowaivers

Europe – ICH M9 on biopharmaceutics classification system based biowaivers – Step 2b –...

Summary This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III...
GSK’s says depot HIV injection works over three years

International – GSK’s says depot HIV injection works over three years

GlaxoSmithKline’s bid to develop an alternative to daily dosing of HIV drugs has made further progress, with new data backing the efficacy of a...
Novartis urges government to ‘minimise disruption’ in no-deal Brexit

Europe – Novartis urges government to ‘minimise disruption’ in no-deal Brexit

The move follows parliament's rejection of prime minister Theresa May's proposed Brexit deal. The Switzerland-based pharmaceutical giant claimed that “the risk of UK exiting the...

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