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Looking Forward to Pharma's Decade of Predictive Efficacy

 
• By Shirley Haley

Drug developers can now tap into an array of new preclinical technologies including some that give them the ability to interrogate compounds in a broad biological context-a systems biology approach. In this issue, we profile four start-ups with technologies designed to predict drugs' efficacy: Champions Biotechnology, Cytox, Immuneering and Rhenovia.

The next hurdle pharma faces as it endeavors to limit the cost and time associated with its drug development failures is the headache of predictive efficacy. Emergent diagnostics/research tools companies are lining up for the opportunity to help, offering diversity both in approaches and in therapeutic areas.

In the 1980s, the majority of drugs that were tabled had poor pharmacokinetics, leading to a heavy pharma investment in...

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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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EU 15% Tariff Deal Still Leaves Questions For Pharma

 
• By Jessica Merrill

A single 15% tariff rate on imports from Europe includes pharmaceuticals, but it remains unclear if the trade deal will exclude generics or if Trump will offer a grace period.

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
• By Andrew McConaghie

The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Bayer’s Elinzanetant Is Latest Drug Hit By FDA Review Delays

 
• By Kevin Grogan

Comes Days After PDUFA Pushback For GSK's Blenrep.