Best Of BIO: Policy & Regulatory Updates From BIO 2017
Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.
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LPAD Approval Pathway Is Not Saving Antimicrobial Development
US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.
Gottlieb Floats New Antibiotic Payment Model In LPAD Announcement
US FDA Commissioner outlines licensing fee reimbursement arrangement intended to provide better financial incentives for development.
Aldeyra's Allergy Drug Misses Endpoint But Company Sees Market Gap
Aldeyra is moving ahead with plans for Phase III trials of its novel allergy drug in the face of a missed Phase IIb endpoint. Its ultimate success could rest on what endpoint the FDA will accept.