Biotech Blueprint

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In this episode: Layoffs, CRLs, and standout trial data from Sarepta, MiNK, SELLAS, DiaMedica, and more (July 11–17, 2025).

THIS WEEK’S KEY TAKEAWAYS 🔑

Sarepta led the week with sweeping changes: the company laid off 500 employees and pivoted toward its siRNA platform after safety concerns with its Duchenne gene therapy, Elevidys, triggered an FDA-mandated black box warning. While...

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While the U.S. gears up for Independence Day, biotech is having its own kind of fireworks. In This Week in Biotech #59, we look at Regeneron landing a major approval for its BCMAxCD3 bispecific; AbbVie making a bold play in in vivo CAR-T; and Argenx entering the macrocyclic peptide race with a $1.5B AI-driven deal.

Meanwhile, RFK Jr. quietly reshapes the vaccine injury landscape, with possibl...

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This week, Biotech Blueprint breaks down the crosswinds shaping the industry:
– Novo Nordisk doubles down on AI drug discovery with an $812M Deep Apple partnership
– The FDA approves UroGen’s bladder cancer drug Zusduri, the first non-surgical option for NMIBC
– Gilead’s HIV program hits a clinical hold, but shares rebound as lenacapavir’s PDUFA nears
– RF...

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In this episode of the Biotech Blueprint Podcast, host Katerina Roznik sits down with Steve Swan, CEO of the Swan Group, and host of the Biotech Bytes podcast, to explore the evolving biotech job market in 2025. They unpack how hiring trends have shifted post-COVID, the rise and limits of AI in recruitment, and why storytelling, communication, and networking are more important than ever.

Steve s...

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In this week’s episode, I break down the biggest stories shaping the biotech and pharma landscape from May 30 to June 7, 2025.

🔬 ASCO 2025 delivered big results in oncology, with AstraZeneca’s camizestrant, Summit’s ivonescimab, and Gilead/Merck’s TROP-2 ADC combo showing major clinical gains.
💰 Strategic dealmaking followed the data, including a $1.5B BioNTech/Bristol Myers deal and Sano...

In this week’s recap, we spotlight three biotech stories that reveal where the sector is headed, both the promise and the pitfalls:

• Gene therapy trials stumble hard: Intellia’s in vivo CRISPR trial was hit with a serious liver toxicity case, sending shares tumbling and reigniting concerns over editing DNA inside the body. But the real blow came for Rocket Pharma, which saw a patient death trigger an FDA clinical hold and a 60% s...

Is this the end of animal testing? | Biotech Blueprint Podcast

For nearly a century, animal testing has been a cornerstone of drug development. But that paradigm is starting to shift.

In this episode, I speak with Dr. Patrick Creisher, PharmD, PhD, a scientist who’s worked with both animal models and human organoids, about the FDA’s new roadmap for preclinical testing. We unpack the agency’s April 2025 announcement, what it means for...

In this week’s recap, we cover three biotech stories that signal big shifts in regulation:

• FDA tightens Covid booster rules: The FDA announced it will now require vaccine makers to run new clinical trials if they want to market annual covid boosters to healthy Americans under 65. Older adults and high-risk groups, roughly 100–200 million people, will still get access without delay. The move signals a new, more cautious regulator...

In this week’s episode, we break down three major biotech stories from May 9–16, 2025:

• The White House revives the “Most Favored Nation” drug pricing model, aiming to tie Medicare prices to those paid abroad, but with little enforcement or funding, it’s more signal than substance.
• Novo Nordisk strikes a $2.2B deal to develop oral obesity drugs with Septerna, then sees the surprise resignation of its longtime CEO amid competit...

Biotech Blueprint is a newsletter and a podcast where biotech professionals and industry insiders come together to unpack the trends, challenges, and breakthroughs shaping the future of biotech. In our first episode, I sat down with Hartaj Singh, veteran biotech analyst and founder of Biotech Capital Compass, for a candid conversation about career pivots, the rise of mRNA cancer vaccines, AI in drug discovery, and what recent layof...