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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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Deal Watch: Novartis Hopes To Ace Inflammatory Disease With Matchpoint Tie-Up

 
• By Joseph Haas, Lisa Takagi, and Manas Mishra

Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Executives On The Move: Three New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Trogenix and Quetzal Therapeutics, plus Synendos Therapeutics gains a new CMO from Roche.