1. Pink Sheet

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 this year to 23, topping 2016's total of 22 less than halfway through the year

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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.