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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 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

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

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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).

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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
– 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 vaccine

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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 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.

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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 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.

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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 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 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 short

• Why the FDA believes New Approach Methodologies (NAMs) may be more human-relevant

• What role AI could play in making drug development faster, cheaper, and more ethical

• Whether companies like Charles River and Jackson Labs need to adapt or risk falling behind

The question is no longer if we move away from animal testing, but when, and how fast.

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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.

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