1. Pink Sheet

Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives

 
• By Michael McCaughan

Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.

Antibiotic resistant bacteria closeup biofilm

President Donald Trump has placed special emphasis on reversing initiatives directly associated with his predecessor, but one important Obama era executive order for the biopharma sector has – so far at least – remained in effect: the initiative to combat antibiotic resistance.

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More from Legal & IP

More from Pink Sheet

African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

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.