This week we are speaking with the chief executive of British drug development company Ellipses Pharma.  Founded in 2018 to create new cancer therapies, the firm is following a unique multimodal approach to clinical development, leveraging a variety of technologies. That’s not the only way that Ellipses is rethinking drug development. The company uses a consultative model to provide an unbiased vetting process for candidates, with the goal of de-risking initial asset selection. Ellipses also wants to make sure that capital is invested in the most efficient way, pursuing a portfolio-bas ..read more

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 wave of innovation in the life sciences. Much of the innovation has come from smaller biotech firms, som ..read more

With an Accelerated nod for Aduhelm (aducanumab) and now full approval for Leqembi (lecanemab) in the USA, Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have overturned decades of failure in Alzheimer’s. But at the annual meeting of the Alzheimer’s Association (AAIC), it’s another neurology heavyweight taking center stage, as Eli Lilly (NYSE: LLY) makes clear its intention to remain a leader in the treatment of this challenging disease. At the AAIC in Amsterdam, we’re speaking with two key figures from the development program for donanemab, a candidate which could slow cognitive decline for mi ..read more

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, sticking with its Alzheimer’s research even when times were tough and it looked like a clinical break ..read more

Set against a backdrop of foundering confidence in biotech stocks, the success of some companies incubated by Massachusetts-based Flagship Pioneering has been remarkable. Flagship has invested billions of dollars getting startups off the ground, many of which, such as Foghorn Therapeutics (Nasdaq: FHTX), Codiak Biosciences (Nasdaq: CDAK) and Rubius (Nasdaq: RUBY), have gone on to become publicly-traded companies. Moderna Therapeutics (Nasdaq: MRNA), the poster child for the firm’s strategy, has generated tens of billions of dollars while saving millions of lives with its mRNA-based coronavir ..read more

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 head of 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 leaked draft and outline the most significant impacts, good and bad. Some of the measures to be con ..read more

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 Build Back Better plan. Democrats have had to scrap limits on certain drug price increases above infl ..read more

For years, commentators have observed that drug prices in the USA are significantly higher than elsewhere in the world. Pointing to the high levels of innovation in the USA, a country where new drugs and biologics tend to get launched first, argue that market-based pricing funds essential research and development. As the US Congress debates more government intervention to improve access, including the potential for the federal insurance fund Medicare to actively negotiate drug prices, one company is looking to work with the system to achieve the same result. Launched in 2019, EQRx (Nasdaq ..read more

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-fold increase since 2015. While the broad picture is clear, a detailed look at where this activity is foc ..read more

With the approval of Aduhelm (aducanumab), the first new Alzheimer’s treatment in decades, people affected by dementia were given new hope that a breakthrough had finally arrived. A year later, the product is yet to gain traction in the USA, the only country to have approved it, and developers Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have been forced to rely on confirmatory trials to open up reimbursement - results from which are not expected for some time. Despite the setbacks, the US Food and Drug Administration's accelerated approval for the amyloid beta-targeting antibody has reignite ..read more