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TREAT Act Wants Accelerated Approval Change, But Uses Existing Language

 
• By Derrick Gingery

Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.

Sen. Kay Hagan’s TREAT Act may do no more to expand the use of the accelerated approval pathway than simply shine more light on the agency’s existing regulations and encourage FDA to implement more effective ways of expediting approvals.

The bill, which the North Carolina Democrat introduced Feb. 15, claims to build on the existing accelerated approval pathway. The...

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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
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Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.