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Re-Engineering Drug Development II: Clinical Data Collection & Management

 
• By Antonio Regalado

Despite a history of failed products, start-up companies are looking to reinvent how data from clinical trials is collected and managed. Firms are trying to replace the point solutions of the past with broad software offerings that can take clients from "site to submission."

Eli Lilly & Co. Parexel International Corp. Quintiles Transnational Corp. Covance Inc. Pharmaceutical Product Development Inc.

In front-page cover age of the pharmaceutical industry's latest proposed mega-merger, a Wall Street Journalheadline trumpeted "Cost of Drug Research Is Driving Merger Talks of Glaxo, SmithKline." The thesis: Genomics...

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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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ASCO: Rusfertide Inches Toward FDA Filing With Positive 32-Week Data

 
• By Alaric DeArment

Takeda/Protagonist are awaiting 52-week data to confirm the results from the VERIFY trial of the drug in polycythemia vera.

ASCO: Trodelvy First-Line TNBC Data Seen As Potentially Practice-Changing

 
• By Alaric DeArment

Gilead chief medical officer Dietmar Berger said in an interview that the company plans to quickly take the results to regulators and foresees broad first-line use of the drug.

ASCO: Merck’s Zilo-V Shows Activity, But Numbers Still Small

 
• By Alaric DeArment

The drug boosted overall responses on top of the R-GemOx backbone, but the discussant pointed out that patients in waveLINE-003 were not very heavily pretreated.