Trade Resources Industry Views Heat Biologics Has Filed an Investigational NDA with FDA for HS-410

Heat Biologics Has Filed an Investigational NDA with FDA for HS-410

US-based clinical stage biopharmaceutical firm Heat Biologics has filed an investigational new drug application (NDA) with the US Food and Drug Administration (FDA) for its second product candidate, HS-410, which will be evaluated in bladder cancer.

Heat Biologics had also appointed Melissa Price as the vice president of clinical and regulatory affairs.

Dr Price will direct the company's regulatory strategy and also will be responsible for the implementation of the company's HS-410 bladder cancer program, as well as all of company's clinical studies.

Heat Biologics chief executive officer Jeff Wolf said Price's oncology experience will serve the company well as it continues to progress its two lead product candidates through clinical trials in non-small cell lung and bladder cancers.

"With the filing of the IND for our second product candidate, our clinical development activities are increasing and we are pleased to have Melissa spearheading the effort," Wolf added.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/heat-biologics-submits-ind-application-to-fda-for-bladder-cancer-product-candidate-021013
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Heat Biologics Submits Ind Application to FDA for Bladder Cancer Product Candidate