1. Pink Sheet

Genentech’s Actemra Receives Breakthrough For Systemic Sclerosis; Potential Future Beneficiary of OPEN ACT?

 
• By Paige Monborne

The potential new indication for Actemra could be an early beneficiary of a six-month patent extension, if the Cures legislation is enacted and orphan designation exclusivity remains a feature of the bill.

FDA has granted “Breakthrough Therapy” designation for Roche/Genentech Inc.’s Actemra (tocilizumab) in the treatment of Systemic Sclerosis. 

That makes it one of many products to qualify for the new expedited pathway created in 2012, but this one...

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More from Legislation

More from Pink Sheet

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.