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NME Mid-Year Report: Approvals Might Near Record With Strong 2nd Half

 
• By Michael Cipriano

CDER approved 23 new drugs in the first half of 2017, topping the 22 approved in all 2016; there are at least 18 products in CDER's pipeline with a user fee date this year.

FDA entrance sign 2016

After exceeding its 2016 tally of new product approvals by June this year, the Center for Drug Evaluation and Research (CDER) could continue to build off its busy first half and approach record territories for 2017, as another large swath of applications are due for a decision over the next six months.

The US FDA approved Portola Pharmaceuticals Inc.'s blood thinner Bevyxxa (betrixaban) June 23, bring the novel drug approval total...

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
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Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.