The Pharma Letter Podcast

This week we’re focusing on an area of clinical research that has been of great interest for a number of years, that is NASH, also known as MASH. It’s a high area of unmet medical need, with over 20 million diagnosed cases across Europe and the USA, and while there are more than 80 therapies currently in the pipeline, only around 5% of these are in Phase III development. One company working in this area is San Francisco-based 89bio (Nasdaq: ETNB), which has a candidate now in Phase II...

In the world of outsourced clinical research, ICON is a big fish in a pond full of other increasingly big fish. In this episode of The Pharma Letter Podcast, we chat with the company’s chief commercial officer, George McMillan. Like many in the industry, the Dublin-headquartered clinical research organization (CRO) has sought to grow in size to take advantage of increasing demand for its services. A coming together of numerous advances in biotechnology over recent years has led to a new wa...

In the runup to the annual meeting of the Alzheimer’s Association, this week we are speaking with Michael Irizarry, deputy chief clinical officer at Eisai US. At the event in July, there will be plenty to discuss, with recent new data from Eli Lilly (NYSE: LLY) suggesting its anti-amyloid candidate, donanemab, is likely to provide healthy competition for Eisai's (TYO: 4523) own Alzheimer’s product, lecanemab - marketed in the USA as Leqembi. Like Lilly, Eisai has been a pioneer in neurology...

A draft of the European Commission’s ongoing review of pharmaceutical legislation has leaked, prompting a bitterly-worded reaction from drugmakers, which accuse legislators of “sabotaging” the industry. There is no doubt that the proposals represent serious change. Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin, describes them as the most far-reaching for decades. On this week’s episode of The Pharma Letter Podcast, Mr Meulenbelt will walk us through...

The outcome of the recent midterm elections in the USA surprised many by returning a Democrat-led Senate, preventing Republicans from gaining control of the next Congress. Analysts, having expected a stronger showing for Republicans, put some of the blame on former president Donald Trump, whose endorsements and active involvement in campaigning were said to frighten off moderates. In this week’s episode of The Pharma Letter Podcast, we are joined by Stephanie Kennan, senior VP for federal pub...

As President Joe Biden signs the Inflation Reduction Act into law, drugmakers in the USA are poring over the likely impact on drug prices, and how best to respond to its enactment. The legislation passed in the US Congress with Vice President Kamala Harris casting the decisive vote in an otherwise deadlocked Senate. That evident lack of bipartisanship put the kibosh on Democrats’ more ambitious plans, with the new law representing a greatly watered down version of the original $3.5 trillion...

Interest in the potential for artificial intelligence to transform different aspects of the drug discovery and development process is at an all-time high. According to industry analyst GlobalData, the number of AI deals in pharma has doubled in the last three years, reaching 85 in 2021, and more pharmaceutical companies are hiring for AI roles than ever before. Another way of gauging interest is to look at the number of AI-based patents granted over time, with analysts recording a three-fol...

In recent years there has been an explosion of digital tools and platforms in the life sciences industry, designed to improve processes ranging from drug discovery and development, through to registration and commercialization. As with everything in pharma and biotech, the value of these tools hinges on the strength of the underlying data, making it essential to capture research in a robust and reliable way. One UK-based company, Labstep, is helping researchers to accomplish this with a ful...