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Commentary: How to win the hearts and minds of regulatory agencies, by Bert Spilker

 
• By Bert Spilker

There is no question that some pharmaceutical companies have an easier time than others in negotiating with regulatory agencies. Knowing how best to approach regulators is essential, says long-time drug development and regulatory affairs expert Bert Spilker.

There is no question that some pharmaceutical companies have an easier time than others in negotiating with regulatory agencies. Knowing how best to approach regulators is essential, says long-time drug development and regulatory affairs expert Bert Spilker.

The differences between companies in their dealings with regulatory authorities are often the result of the ways in which companies...

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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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Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

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Top 10 Drugs Q1 2025: Keytruda Dominates; Mounjaro Climbs

 
• By Eleanor Malone

Lilly’s Mounjaro for diabetes rose from sixth to third position among the top-selling drugs in the first quarter of 2025, Rival Ozempic retained second position and Merck & Co’s immuno-oncology blockbuster Keytruda stayed far ahead.