Biotech Blueprint

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Compounded semaglutide draws FDA scrutiny as Novo Nordisk guides 2026 lower and Eli Lilly leans into a $50 Medicare copay (Jan 30-Feb 5, 2026).Follow Biotech Blueprint at biotechblueprint.com.

FDA pauses two AAV programs, Sanofi reports US vaccine uptake slipping, and CMS widens negotiations to more blockbuster drugs (Jan 23-29, 2026).Subscribe to Biotech Blueprint at biotechblueprint.com.

This Week in Biotech #86. Subscribe to Biotech Blueprint for free at biotechblueprint.com. KEYNOTE-942 durability, plus GSK’s $2.2B RAPT food allergy deal, BMS partners with Janux, Corcept's overall survival win, and Corvus posts Phase 1 eczema data (Jan 16-22, 2026).

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I sat down with NImmune CEO Josep Bassaganya-Riera to talk about omilancor, their gut-restricted oral IBD drug now in Phase 3 clinical trials. We cover LANCL2 biology, their biomarker aimed at boosting response rates, and the TITAN-X platform that helps guide real development decisions. A really interesting look at how you build an oral immunology company in 2025.Follow Biotech Blueprint for free at https://www.biotechblueprint.com/NImmune Biopharma: https://nimmunebio.com/Josep's LinkedIn profile: https://www.linkedin.com/in/josep-bassaganya-riera/ Connect with me on LinkedIn: https://www.linkedin.com/in/katerina-roznik/

Plus Duchenne’s landmark phase 3 win, a survival boost in glioblastoma, motion sickness momentum at Vanda, and ACIP’s newborn vaccine chaos (Nov 21-Dec 4, 2025).Subscribe to Biotech Blueprint for free at biotechblueprint.com.

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Subscribe to Biotech Blueprint for free at biotechblueprint.com. A week of rare regulatory momentum, strategic M&A, and meaningful clinical wins.

Subscribe to Biotech Blueprint at biotechblueprint.com In today's episode:How an Oxford-born, YC-backed startup is betting that cell-based production will define mRNA’s next decade.

Subscribe to Biotech Blueprint for free at biotechblueprint.com.Pfizer’s courtroom gamble to block Novo Nordisk’s $10B Metsera takeover failed, and Novo immediately fired back with an even higher bid, leaving Pfizer two days to respond before the Nov. 13 vote. Meanwhile, Trump struck landmark pricing deals with Novo and Lilly to bring GLP-1 drugs like Ozempic and Mounjaro to Medicare at $245 a month. Moderna tightened its belt and beat expectations with $1 B in revenue, J&J scored an FDA win for Caplyta in depression, and Viking’s next-gen GLP-1 showed it can actually reverse metabolic syndrome.

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Subscribe to Biotech Blueprint for free at ⁠biotechblueprint.com⁠. About this episode: mRNA’s next chapter isn’t just flu and COVID. We break down why latent viruses (CMV, EBV, HSV) persist, why T cells matter, and how multi-antigen mRNA vaccines aim to control reactivation. We also cover Moderna’s CMV Phase 3 (mRNA-1647) as a platform stress test and the rise of personalized neoantigen cancer vaccines (V940) that cut melanoma recurrence vs Keytruda alone in Phase 2b and are now in Phase 3. What success here would mean for public health, operations, and the mRNA platform.

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Read the full edition or subscribe to Biotech Blueprint herehttps://www.biotechblueprint.com/p/pharma-tariffs-on-ice-fda-limits?r=474vk1

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Welcome to Biotech Blueprint. If you want to subscribe to a free weekly biotech/pharma newsletter, you can do so here: https://www.biotechblueprint.com/embed In this special episode, I teamed up again with Hartaj from the Biotech Capital Compass for part one of our mRNA therapeutics mini series. We covered the foundational science behind how RNA became medicine, the decades of bioengineering breakthroughs that made COVID vaccines possible, and what’s coming next in the infectious disease space. From Moderna’s ambitious pipeline targeting everything from flu-COVID combo shots to latent viruses like CMV and EBV, to Moderna’s and BioNTech’s custom cancer vaccines, we mapped out what's actually coming in the next few years.

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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 next.

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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-mandated black box warning. While painful, the restructuring was met with investor optimism, driving the stock up nearly 40%.On the clinical front, SELLAS reported standout phase 2 data for its CDK9 inhibitor in relapsed AML, with response rates more than double historical expectations and a move into front-line trials now underway. Similarly, DiaMedica impressed with early data in preeclampsia, a space with no approved drugs, showing significant blood pressure reductions without crossing the placenta.MiNK Therapeutics soared 500% after publishing a striking case study: a full remission in metastatic testicular cancer using its off-the-shelf iNKT cell therapy. While the data is from a single patient, the durability and safety profile suggest meaningful potential for solid tumors.Not all news was positive. Capricor’s Duchenne therapy was rejected by the FDA despite priority review, sending shares tumbling over 50%. Ultragenyx also received a CRL for its Sanfilippo gene therapy, though the delay was attributed to manufacturing issues, not clinical concerns.Elsewhere, AstraZeneca’s AL amyloidosis antibody failed its phase 3 primary endpoint but showed signs of efficacy in a subset of patients, setting up a potential niche strategy. And in a surprise twist, 23andMe was acquired by Anne Wojcicki’s nonprofit TTAM Research Institute, edging out Regeneron in a bidding war that reignited debate over the future of consumer genomics.

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.

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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 vaccine injury landscape, with possible implications for every major COVID vaccine maker.Also inside: — China’s first dual GLP-1/GCG agonist approval — Moderna’s latest win in seasonal flu — Key updates on ACA coverage, RSV policy, and Alzheimer’s trials

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).

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).

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 lenacapavir’s PDUFA nears– RFK Jr. removes the entire CDC vaccine panel, replacing members with mRNA skeptics– Senators Sanders and King reignite the push to ban direct-to-consumer drug ads– CRISPR Therapeutics rides the FDA’s accelerated approval momentum– Vaxart surges on promising data for its oral norovirus vaccineSubscribe to stay ahead of the science, policy, and market signals shaping biotech.

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 networking are more important than ever.Steve shares insider advice for both new graduates and experienced professionals on navigating job tenure, understanding stock compensation, and identifying high-growth roles in biotech and pharma, especially in data and AI-driven areas.

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 BioNTech/Bristol Myers deal and Sanofi’s $9.1B Blueprint Medicines acquisition.💊 Regeneron staked a claim in obesity, pushing beyond GLP-1s with a muscle-sparing antibody combo and a dual agonist licensing deal.🧬 Gene therapy remains scientifically strong but commercially uncertain-Regenxbio soared in the clinic but dipped on Wall Street.📈 Markets showed a cautious rebound, with XBI and IBB edging up and Omada Health making a strong IPO debut under ticker OMDA.We also spotlight clinical standouts from Moderna and more.If you enjoy this content, subscribe to the newsletter below.

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% stock drop. Safety remains the field’s biggest challenge.CDC reverses COVID vaccine guidance: Under new leadership from RFK Jr., the CDC will no longer recommend COVID-19 vaccines for healthy kids and pregnant women. The move was praised by skeptics and blasted by the medical community, who warned it undermines trust in science and public health.A win for antibiotic innovation: GSK and Spero reported that their oral UTI drug matched IV antibiotics in a phase 3 trial, prompting an early stop for efficacy. If approved, it would be the first oral carbapenem in the U.S., a potential game-changer for patients with drug-resistant infections. Shares of Spero surged 250%.Thanks for tuning in. I’ll be back next week with more biotech news you need to know.

Is this the end of animal testing? | Biotech Blueprint PodcastFor 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 the future of drug safety, and how emerging technologies like AI, organoids, and organs-on-chips are beginning to reshape the landscape.We discuss:The science behind organoids and chips, and where they fall shortWhy the FDA believes New Approach Methodologies (NAMs) may be more human-relevantWhat role AI could play in making drug development faster, cheaper, and more ethicalWhether companies like Charles River and Jackson Labs need to adapt or risk falling behindThe question is no longer if we move away from animal testing, but when, and how fast.🎧 Subscribe to our podcast and newsletter, and listen to stay ahead in biotech.

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 regulatory posture under Commissioner Marty Makary and CBER Director Vinay Prasad, aiming to limit unnecessary repeat dosing. While the market for boosters narrows, investors were reassured that revenue from high-risk populations remains secure.Novavax finally gets its Covid moment: After years of delay, Novavax finally landed full FDA approval for its covid vaccine, Nuvaxovid, for adults 65+ and high-risk individuals aged 12–64. It’s the first non-mRNA vaccine fully approved in the U.S., and the decision triggers a $175M milestone payment from commercialization partner Sanofi. Shares jumped 16% on the news, signaling renewed optimism for the company after a long road through emergency use authorization limbo.Psychedelic therapies get a regulatory tailwind: In a surprising shift, FDA Commissioner Makary said evaluating psychedelics like MDMA and psilocybin would be a “top priority” for Trump administration. His comments, aired in a NewsNation interview, signaled a willingness to fast-track reviews, especially for PTSD treatment in veterans. It’s a notable departure from the previous administration’s rejection of an MDMA-based therapy last year. Shares of MindMed, COMPASS Pathways, Atai, and Cybin all saw upward movement as investor confidence rebounded.Read our deep dive on this topic HERE.Thanks for listening!

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 competitive pressure from Eli Lilly.• Biohaven’s stock tumbles 22% after the FDA delays its review of troriluzole, a rare disease therapy, citing the need for an advisory committee meeting.Subscribe for weekly biotech recaps plus deep-dive interviews with industry and academic experts.

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 biotechblueprint.substack.com

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 layoffs in the public and private sectors signal for the industry's next chapter. We also dive into how we each curate biotech news, why community matters, and what it means to build a life and career in this ever-evolving space. This is just the beginning of a series aimed at honest, thoughtful discussions with those moving biotech forward.