Katerina Roznik

Biotech Blueprint

Connecting with biotech, pharma, and academic professionals to explore the latest in science, startups, market trends, and breakthroughs. For more content, please subscribe to biotechblueprint.substack.com.

Autor

Katerina Roznik

Kategorie

Technology

Neueste Folge

19. Mai 2026

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FDA Shake Up, Sarepta Rebounds, and Trump Targets Drug Prices — This Week in #Biotech 63 01.08.2025

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Sarepta, Elevidys, and the Future of AAV Gene Therapy 29.07.2025

Subscribe to Biotech Blueprint HERE and to Biotech Capital Compass HERE . In this episode of the Biotech Blueprint podcast, I teamed up with the Biotech Capital Compass to break down Sarepta Therapeutics’ recent safety crisis, and what the FDA’s partial green light means for Elevidys, investor confidence, and the broader AAV field. We dig into the science, regulatory dynamics, and what might come...

Sarepta’s Gene Therapy Crisis Deepens — This Week in Biotech #62 25.07.2025

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CRISPR in 2025: Clinical Use, Regulatory Pressure, and Future Promise 18.07.2025

Welcome back to Biotech Blueprint! In this week’s special episode, I teamed up with the Biotech Capital Compass to examine where gene editing stands today, scientifically, commercially, and clinically. This marks the start of a multi-part series on gene therapies, viewed through both scientific and investment lenses. Subscribe to Biotech Blueprint and Biotech Capital Compass .

Sarepta’s $400M Pivot, MiNK’s 500% Surge, and AML Breakthroughs — This Week in Biotech #61 18.07.2025

Subscribe to Biotech Blueprint for free HERE . 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-m...

KalVista’s FDA Win, Merck’s $10B Deal, and CRISPR Momentum — Biotech #60 14.07.2025

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Sparks Fly in Biotech — This Week in Biotech #59 03.07.2025

Subscribe to Biotech Blueprint HERE . 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 vacc...

FDA Drama & Psychedelic Setback — This Week in Biotech #58 27.06.2025

Subscribe for FREE HERE . FDA turmoil impacts key drug decisions, Compass’s phase 3 psilocybin data spooks investors, and Exelixis soars on cancer results (June 20–26, 2025).

HIV Breakthrough & Gene Editing Deals — This Week in Biotech #57 20.06.2025

Subscribe for free HERE . Gilead’s HIV breakthrough, Lilly’s $1.3B gene editing deal, and FDA reform efforts. Listen to the biggest news from biotech and pharma this week (June 13–19, 2025).

Biotech Caught Between AI Momentum and Political Turbulence — This Week in Biotech #56 13.06.2025

Subscribe to Biotech Blueprint, FREE weekly newsletter HERE . 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 lenacapavi...

Navigating Biotech Jobs in 2025: AI, Networking, and Career Strategy 11.06.2025

Subscribe to Biotech Blueprint 👉 HERE . 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 networki...

ASCO Breakthroughs, Gene Therapy Stumbles, and Omada's IPO debut — This Week in Biotech #55 09.06.2025

Subscribe to Biotech Blueprint here . 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 B...

CRISPR Setbacks, Vaccine Policy Reversed, and an Oral Antibiotic Breakthrough — This Week in Biotech #54 02.06.2025

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...

Organoids, AI, and the FDA’s Move Away from Animal Models 29.05.2025

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...

Tighter Boosters, Novavax's Win, and Psychedelic Signals — This Week in Biotech #53 23.05.2025

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 signa...

Medicare Benchmarking, Novo's Transition, and Biohaven's Setback — This Week in Biotech #52 19.05.2025

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...

CRISPR, Prasad, and the NIH budget bomb — This Week in Biotech #51 11.05.2025

This Week in Biotech #51 (May 2–10, 2025) CRISPR’s cholesterol breakthrough, the FDA’s new CBER chief rattles markets, NIH faces historic budget cuts, and Charles River pivots as animal testing falls out of favor. Plus: Gilead, Vertex, and key approvals you might’ve missed. 📺 This is a short weekly recap video, perfect for staying current in just a few minutes. Subscribe to our FREE newsletter on...

From Wall Street to Wet Lab: Mapping the Future of Biotech 03.05.2025

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 d...

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