Dear colleagues, The first three weeks of May produced multiple senior departures at the FDA. The leadership turnover is beginning to shape how companies plan their submissions and how they disclose their risk to investors. For sponsors, the central concern is continuity across FDA interactions. Earlier this year, Replimune and Moderna showed how costly it can be when agency expectations shift after a company has already built around a filing path. This time, the question is

Dear colleagues, April 2026 saw four biotech initial public offerings (IPOs) price at the top of their marketed ranges, raising approximately $1.5 billion in aggregate gross proceeds. Early aftermarket trading has been constructive overall, though performance has already separated across the cohort. The deals signal a meaningful, but selective, thawing of the IPO window. Public investors are engaging, but the bar remains high: April’s issuers all brought clinical-stage assets

Dear colleagues, Q1 2026 closed with more than $45 billion in biopharma M&A, with deal premiums at their highest level in two years. We see buyers responding to different pressures, each with distinct implications for timing, valuation, and transaction design. In this issue, we share our read on two themes from recent M&A activity, along with a few external resources we have found useful. Headland team members will be at multiple upcoming conferences, including AACR and B

Dear colleagues, Last fall's Most Favored Nation (MFN) news focused on voluntary individual pharma deals with the White House. Two new proposals from the executive branch would make MFN-style pricing mandatory industry-wide. The Centers for Medicare and Medicaid Services (CMS) introduced GLOBE and GUARD in December 2025 to extend MFN pricing logic across Medicare Part B (GLOBE) and Part D (GUARD). The strategic implications run deeper than the headline. Launch sequencing, dea

Hello friends and colleagues, As we reflect on Women’s History Month, we would like to take the opportunity to shine a spotlight on...

Hello friends and colleagues, As we close out a short month packed with major updates and announcements, we are using this Leap Day to...

Greetings friends and colleagues, Happy New Year and welcome to our first newsletter of 2024! As we usher in another promising year, we...

Dear Readers, As our economy continues to change, we thought it would be helpful to share some insights and industry patterns that we...

Dear friends and colleagues, “Biotech’s flameout,” “bloodbath,” “thousands of layoffs.” We’ve all heard it, and we’re in it. Whether...

To help our readers prepare for their next financing round, we’ve compiled a list of the 5 must-have slides for any investor pitch deck....

Dear Readers, As we gear up for conference season, we thought it could be helpful to share some tips on how to succeed while at a...

Many of our clients are pursuing groundbreaking therapies in disease areas with high unmet medical needs, giving our firm the chance to...

One of our most sought-after commercial strategy services is the creation of revenue forecasts. As such, we’ve spent numerous projects...

Our work at Headland covers a wide range of diseases and therapeutic areas, and we try to stay abreast of recent news and developments in...

As we’ve expanded our US-Japan services, we are often asked about the differences between the US and Japanese biopharma industry. There...

Last month we attended the first completely virtual BIO conference. We met with many innovative companies and are looking forward to...

A note from our CEO, President, and Founder: My team and I are deeply troubled by the ongoing examples of violence, cruelty, and...