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Amgen/Apotex Appeals Arguments Aimed At April

 
• By Donna Young

The US Court of Appeals for the Federal Circuit said it will hear oral arguments on April 4 in Apotex Inc.'s appeal in a lawsuit brought by Amgen Inc., which has been trying to delay the marketing of the biosimilars maker's version of Neulasta (pegfilgrastim) – a product that has yet to receive the FDA's approval.

The US Court of Appeals for the Federal Circuit said it will hear oral arguments on April 4 in Apotex Inc.'s appeal in a lawsuit brought by Amgen Inc., which has been trying to delay the marketing of the biosimilars maker's version of Neulasta (pegfilgrastim) – a product that has yet to receive the FDA's approval.

The case is the second time the Federal Circuit will weigh in on the Biologics Price Competition and Innovation Act...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

Sarepta Market Dynamics For Elevidys Imperiled By Second Patient Death

 
• By Joseph Haas

With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.