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Antibiotic Legislation Offers Big GAIN For Small Firm: Rib-X Extends Delafloxacin Exclusivity

 
• By Emily Hayes

Rib-X is among the first to take advantage of the Generating Antibiotic Incentives Now provisions of the FDA reauthorization legislation with five years’ extra exclusivity for its lead broad spectrum antibiotic candidate, a next-generation fluoroquinolone. Designation for the program came swiftly, company says.

Melinta Therapeutics Inc.’s next-generation fluroquinolone delafloxacin now has another five years’ of marketing exclusivity, as one of the first drugs to receive a qualified infectious disease product designation under the Generating Antibiotic Incentives Now provisions recently passed by Congress.

Patents covering composition of matter of the Phase III-ready delafloxacin expire in 2016, including additional patent term adjustments or patent...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

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