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Mining The Microbiome: Are Gut Microbes The Next Big Source Of Drugs?

 
• By Melanie Senior

There is growing interest in the gut microbiome as a source of new therapies across a wide range of diseases. Although it is still an emerging field, pharmaceutical firms and other investors are engaging, with more expected to follow.

Much of modern medicine since the Middle Ages was born out of the fight against harmful bacteria – the so-called germ theory of disease. Now, though, a growing number of scientists believe bacteria may be the source of an entire new generation of therapeutics. They’re looking at the trillions of (mostly friendly) microorganisms, including over 1,000 bacterial species, found in the human gut.

The collective gene sequences of these bacteria, known as the microbiome, have over the last few years generated a flurry of fascinating data on the huge role played by these bacteria and their by-products in health, as well as across a wide range of diseases. These conditions aren’t limited to acute bacterial infections such as hospital-acquired Clostridium difficile – though microbiome work is generating some important new candidates for this unmet need

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Final Chance To Have Your Say: Take Our 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.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

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 In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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Unpacking The Impact Of Trump’s Tariffs On Drug Pricing And Production

 
• By Ed Silverman

Big pharma plans to invest billions of dollars in US manufacturing to avoid tariffs proposed by the Trump Administration. However, the implementation of these plans may be delayed due to regulatory complexities and rising costs from tariffs, potentially impacting drug prices for consumers.

Top-Selling Drugs 2024: Keytruda, Ozempic And Dupixent Dominate

 
• By Eleanor Malone

Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.

Rising Leaders 2025: Christina Ziegenberg On Keeping Medtechs Competitive And MDR Compliant

 
• By Ashley Yeo

Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.