FLEX Shows Erbitux Strength In NSCLC, CRYSTAL Offers KRAS Biomarker
With positive results of the Phase III FLEX study in hand - showing an overall survival benefit for Erbitux in first-line non-small cell lung cancer - Bristol-Myers Squibb and partner ImClone are discussing with FDA their plans to use the data as the basis of a supplemental BLA filing, Bristol said in an interview
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.
Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.
France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.