#57 - AI sharpens up, Merck makes cuts & FDA yields
The coffee break biotech roundup, by SomX.
Hello, my fine molecular manipulators!
This week’s roundup is a real lab bench rollercoaster: Merck gets the scissors out to protect its pipeline, NIH’s new AI learns to check its own work, Sarepta’s DMD gene therapy gets an unexpected FDA green light, we bid farewell to a biotech legend, and meet a synthetic cell that moves using nothing but chemical charm.
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✂️ Merck joins Big Pharma cost-cutting crowd, revealing plan to save $3B annually by 2027 (Fierce Biotech): The scramble comes as Gardasil sales nosedived a whopping 55% year-over-year to $1.1B, whilst the looming patent cliff for Keytruda threatens to gobble up half their revenue stream. They plan to plough every penny back into launching 20 pipeline assets with potential combined revenue of $50B – axing admin and sales roles whilst optimising their global manufacturing footprint. This follows Merck's recent $10 billion Verona Pharmaceuticals acquisition spree.
Our take: Blimey, Merck's playing quite the high-stakes game. With Keytruda's biosimilar set to launch in 2028, they've got three years to morph into a diversified juggernaut. The $50B revenue target sounds rather ambitious, but biotech partners should brace themselves for a frenzied M&A shopping spree as Merck desperately plugs pipeline gaps. Good luck to their portfolio reconstruction that’s now a race against the clock!
📝 GeneAgent reduces AI hallucinations in gene function prediction (GEN): The NIH's rather clever new AI model is tackling artificial intelligence from getting too creative with gene function predictions. Unlike other large language models that waffle or fabricate, GeneAgent fact-checks itself against expert-curated biological databases. When tested on 1,106 gene sets, 92% of its self-verification decisions earned human expert approval. It outperforms GPT-4 on novel gene sets, potentially accelerating drug discovery.
Our take: Finally, an AI that double-checks its homework! This could shift how biotech handles the "unknown unknowns" problem in genomics. Most gene function prediction tools stumble when faced with novel or tissue-specific gene sets, forcing researchers into expensive wet lab validation loops. GeneAgent's self-verification creates a confidence scoring system for AI predictions – vital for regulatory environments where unsupported claims can derail entire programmes.
✅ FDA does 180 on Sarepta, freeing DMD gene therapy for ambulatory patients (BioSpace): Following an investigation into an 8-year-old patient's death, authorities concluded it resulted from influenza and immunosuppression rather than the therapy itself. This swift about-face removes commercial uncertainty for Sarepta, allowing Elevidys back onto the market without additional safety studies. However, holds remain for non-ambulatory patients following earlier liver-related deaths. This reversal comes amongst Dr. Prasad's recent CBER departure adding another wrinkle to proceedings.
Our take: Prasad's departure feels rather convenient timing, considering he was the architect of the original pause. However, all grudges aside, the agency's forensic investigation approach to this specific death signals something important for AAV developers. Rather than blanket safety pauses, companies now face the challenge of building sophisticated causality assessment capabilities to distinguish therapy-related deaths from coincidental ones in these vulnerable populations.
🎖️ William J. Rutter, biotech pioneer of gene-based medicine, dies at 97 (The New York Times): The co-founder of Chiron Corporation passed away on July 11th. Founded in 1981, Chiron helped establish the Bay Area as a biotech hub through groundbreaking recombinant DNA work. Under Rutter's guidance, Chiron achieved remarkable breakthroughs including the first genetically engineered hepatitis B vaccine, the first federally approved multiple sclerosis treatment, and discovering the hepatitis C virus. His pioneering contributions ultimately led to the $9.5 billion acquisition by Novartis in 2005.
Our take: Rutter's lasting contribution was demonstrating how academic excellence could translate into life-saving commercial applications that today's biotech founders still follow. Chiron ran with big ideas and built them into systems – recombinant platforms, molecular diagnostics, and vaccines – all before most had a name for it. Companies continue using his model of translating deep science into clinical breakthroughs, and his legacy lives on in every gene-based therapy.
And finally…
⚡ Scientists create an artificial cell capable of navigating its environment using chemistry alone (Phys.org): Brain boxes at the Institute for Bioengineering of Catalonia have engineered the world's simplest artificial cell capable of movement. This rather nifty "minimal cell" consists of a lipid bubble packed with enzymes that propel it towards chemicals via chemotaxis, mimicking how living cells hunt nutrients. They enclosed glucose oxidase enzymes within liposomes alongside membrane pores, creating chemical gradients that direct movement towards higher substrate concentrations.
Our take: Who needs fancy genetic motors when you've got chemistry! Clearly, elaborate machinery isn't necessary for navigation – just some clever chemistry and membrane physics. These artificial wanderers could become superb drug delivery vehicles, navigating straight to diseased tissues like biological homing missiles. The modular design allows incremental complexity additions; it's sophisticated yet elegantly simple – brilliant engineering, really!
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