Stock Watch: Full Approval And Surrogates Await Clinical Validation

Time Is A Great Leveller Among Outcome Measures

When surrogate endpoints are used for accelerated approvals in advance of more compelling functional outcomes, how long should the duration of the confirmatory studies be?

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

In the 2011 dystopian movie In Time staring Justin Timberlake, people stop aging after 25 and have to buy time to extend their lifespans. The rich already have centuries or even millennia while the poor literally live from one paycheck to another. In this reality, however, a related conundrum for those investing in longevity-extending companies is what would the duration of a clinical trial need to be to demonstrate lifespan extension. The conundrum becomes more acute when elderly billionaire investors who on the one hand are ambivalent to drug reimbursement and perhaps even clinical trial costs, realize on the other that the decades needed to conduct a clinical program will exceed their own lifespans. In more traditional indications like oncology and cardiovascular disease, time – or more often the time between events – is also an archetypal outcome.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Stock Watch

Stock Watch: Dollar Weakness, Tariffs, Biosimilars In J&J’s Q1 Mix

 
• By 

Announcing increased full-year earnings guidance and another dividend increase, Johnson & Johnson’s stock price weakened, outweighed by concerns about the replacement of Stelara revenues and possible drug import tariffs.

Stock Watch: Disappointing ACC Share Price Reactions For AstraZeneca And Lilly

 
• By 

The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

Stock Watch: How Tariff Threat Might Boost Pharma Q1

 
• By 

Supply chain disruption fears at the start of the COVID-19 pandemic caused drug over-ordering. Imminent tariffs on drugs may have had a similar effect on pharma sales in Q1 earnings season.

Stock Watch: Are Gene Therapy Prices Too High For Success?

 
• By 

The promise of innovative therapies seems to have been constrained not by efficacy or safety concerns, but because the high price of treatments is incongruous with the reimbursement of short-course therapies.

More from Business

Europe Pharma Heavyweights Call For Higher Drug Prices At Home

 
• By 

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By 

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

Regeneron To Expand US Manufacturing, Citing Commercial And Clinical Expansion

 

The company said the main reason for expanding its manufacturing capacity was its growing US commercial portfolio and clinical pipeline.