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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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Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By Manas Mishra

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

Eolo Pharma Advances In Obesity With Thermogenesis Approach

 
• By Aakash Babu

Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 
• By Sushmita Panda

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.