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New US FDA-funded study aims to alleviate generic Prograf-switching concerns

 
• By Sukaina Virji

The US FDA is to fund a new study at the University of Cincinnati (UC) aimed at ending questions over generic versus brand, and generic versus generic, for tacrolimus – an immunosuppressive drug for transplant patients.

The US FDA is to fund a new study at the University of Cincinnati (UC) aimed at ending questions over generic versus brand, and generic versus generic, for tacrolimus – an immunosuppressive drug for transplant patients.

The FDA put out the 'RFA' call back in April for interested parties to apply for the funding opportunity. The...

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

Recent moves in the industry include changes at the top at Mitsubishi Tanabe Pharma and MC2 Therapeutics, plus MindMed acquires chief financial officer from Longboard Pharma.

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 
• By Sushmita Panda

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 
• By Anju Ghangurde

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?