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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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AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Executives On The Move: New CMOs At Instil Bio, Nkarta & Catalyst Pharma

Recent moves in the industry include changes at the top at iOnctura and Orca Bio, plus Sutro Biopharma, Tenpoint Therapeutics and Helix BioPharma get new CFOs.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 
• By Sushmita Panda

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.