
๐งถ Itโs our job to keep you informed about whatever biomedical chaos the internet cooks up. So letโs talk about Ozempets. Yes, thatโs exactly what it sounds like.
San Franciscoโs Okava Pharmaceuticals is testing whether GLP-1 drugs could slim down the 60% of American dogs and cats classified as overweight. Instead of injections, the team is trying slow-release implants on chubby felines.
Results drop next summer. If they work, donโt be surprised when your once-huggable cat looks at you like a judgy SoulCycle instructor.
๐ฐ Headliners
๐ฐ Pfizer Goes Back for Seconds on Obesity. Pfizer is making another pass at the obesity drug race with a $150 million upfront deal for a GLP-1 program from a Fosun subsidiary. After its previous candidates fizzled, the company is rebuilding its metabolic pipeline with what it hopes is a more durable contender. The move signals Pfizer isnโt ready to let Novo Nordisk and Eli Lilly have the field to themselves. Investors seem cautiously optimistic that the company might finally stick the landing.
๐งช Chinaโs Ascletis Puts Up Real Oral GLP-1 Numbers. Ascletis delivered a 7.7% weight loss result in a US phase 2 trial for its oral GLP-1 therapy, landing it in competitive territory as the sector heats up. The candidate aims to address tolerability barriers while maintaining efficacy. With oral versions seen as the holy grail of the space, these early results position Ascletis as more than just a fringe challenger.
๐ฐ Mirum Buys Its Way Into Hepatitis. Mirum just scooped up Bluejay and its phase 3 hepatitis asset for $620 million, expanding its late-stage liver disease portfolio. The acquisition gives Mirum a potential new revenue pillar with near-term readouts and commercial upside. Itโs a classic move: buy late, launch fast, hope payers donโt revolt.
โ๏ธ FDA Drama Reaches New Volume. The mRNA coalition publicly warned that ongoing upheaval inside the FDA poses a serious threat to public health. Between leadership turnover and policy uncertainty, stakeholders say essential work is stalling at the very moment drug development pipelines are accelerating. The critique underscores how fragile biomedical progress becomes when the regulator is running hot.
โ๏ธ CDCโs Hep B Pivot Sparks Backlash. The CDCโs ACIP voted to revise long-standing guidance around hepatitis B vaccination for newborns, and letโs just say the internet had thoughts. Critics argue the change could roll back decades of progress in preventing HBV transmission. Meanwhile supporters claim updated guidance better reflects real-world risk data.
๐งช FDA Raises the Bar for CAR-T. CAR-T developers woke up to a new reality: the FDA is shifting toward requiring randomized superiority trials for oncology approvals. The agency says tougher standards are needed as the field matures, but companies warn this could slow time-to-market and patient access. Translation: the CAR-T gold rush just got a lot harder.
โ Quick Hits
๐ BioNTech โ CTLA-4 drug shows a survival boost in phase 3, but tolerability remains the sticking point. High efficacy, high baggage.
๐ GSK & Ideaya โ Five-year oncology partnership ends as GSK drops two programs to refocus its pipeline. Sometimes itโs not you, itโs ROI.
๐งฌ Natera โ Buying Foresight Diagnostics for up to $450 million to sharpen its MRD cancer testing arsenal.
โค๏ธ J&J โ An FDA panel rejected the companyโs novel heart-failure shunt implant, dimming hopes for a new cardiac device category.
๐งช BMS โ Snagged a fifth indication for Breyanzi with FDA approval in marginal zone lymphoma. The label keeps growing.
๐ Wave Life Sciences โ Shares shot upward after obesity data impressed investors and put the company squarely in the metabolic conversation.
๐งซ Structure Therapeutics โ Also saw its stock double thanks to competitive oral GLP-1 readouts that investors didnโt see coming.
๐ง Deep Dive
๐ฅ ASH 2025: Blood, Sweat, and Breakthroughs
Hematologyโs biggest week just wrapped, and ASH 2025 delivered enough data drops to keep statisticians gainfully employed for the next six months. From CAR-Ts muscling up to gene therapies proving they can actually go the distance, the field showed itโs entering a new era of faster, smarter, and increasingly curative.
๐งฌ CAR-Tโs Second Act
Gilead and J&J dominated early buzz with strong multiple myeloma readouts, each pushing to define what โbest-in-classโ will mean in 2026 and beyond. Gileadโs anito-cel continued building momentum, while J&J positioned its Tecvayli combo as a plausible second-line CAR-T alternative. CAR-T isnโt just growing, itโs branching out into entire treatment ecosystems.
๐ง Gene Editing Grows Up
Vertex showed early success bringing CRISPR therapy to young children with sickle cell disease and thalassemia. The early goal was met, and clinicians say the data hint that gene editing could be viable much earlier in a patientโs life than originally expected. Fulcrum also posted encouraging sickle cell updates, adding to the gene-therapy-can-actually-work energy throughout the conference.
๐งช Bispecifics, Simplified
Regeneron pitched a streamlined dosing strategy designed to move bispecific antibodies into earlier-line treatment. Simpler regimens could be the unlock bispecifics have been waiting for. Fewer clinic visits, less complexity, and a better shot at competing with CAR-Ts. Itโs a subtle shift, but a strategically huge one.
๐ฉธ Hemophilia Turns a Corner
CSL reported five-year durability for Hemgenix, cementing long-term gene therapy as a legitimate, sustainable option for hemophilia B. Pfizer came armed with new Hympavzi inhibitor data, aiming to level the hemophilia playing field with a challenger that fits neatly into current care.
๐งฉ Rare Diseases Break Through
Novartis unveiled a phase 3 win for ianalumab in a rare autoimmune blood disorder, while a star antibody candidate dazzled across bleeding-disease datasets. The common thread? Companies are getting far better at designing therapies for small, high-need populations, and regulators are paying attention.
๐งญ The Bottom Line
ASH 2025 wasnโt about flashy moonshots. It was about proof. Proof that gene editing can hold up, that CAR-T can evolve, and that rare diseases arenโt afterthoughts anymore. If 2024 was the year hematology promised a revolution, 2025 is the year it started delivering one.
๐ข Key Figure
$277.3M
Drugmakers spent $277.3 million last month airing TV ads for the top 10 pharmaceutical brands. Leading the pack was AbbVieโs Skyrizi, which alone accounted for $56.8 million in airtime, reminding Americaโs skin it could always be clearerโฆ with prior authorization, of course.
๐ Community Vibes
Hereโs what the biotech corners of Reddit are buzzing about this week.
โข โIs Big Pharma like Big Tech?โ
Short answer from the crowd: absolutely not. Pharma is slower, more regulated, and pays less, but many swear by the โbig pharma โ startup โ big pharma againโ loop as the ultimate career cheat code.
โข โCDC policy shifts are freaking people out.โ
Commenters were bleak about the future of US medicine, vaccines, and scientific trust. Many worry the country is slipping backwards despite having more tools than ever.
๐งฌ BioBits
๐งด Novartis โ Struck a $1.7 billion immuno-dermatology pact with a UK AI biotech to find new inflammatory skin disease targets. AI continues its conquest of every therapeutic niche.
๐ง MemoryTell โ An Irish startup analyzing speech clips to flag early cognitive decline. The idea: detect dementia signs long before traditional tests would. Itโs not a replacement, just an early alarm bell.
โ๏ธ Excelsior Sciences โ Raised $95 million to build โmachine-doable chemistryโ for small-molecule design and manufacturing. If they pull this off, AI wonโt just suggest compounds, itโll help create them.
๐ญ Words to Remember
โItโs not about ideas. Itโs about making ideas happen.โ
โ Scott Belsky
๐๏ธ This Day in History
๐ฆ December 9, 1979: Smallpox Eradicated
On this day, smallpox was officially declared eradicated. It was the first and only human infectious disease to get wiped off the map.
See you next time ๐ and if society keeps making chaotic decisions about vaccines, we may one day write:
โOn this day in history, hepatitis B (and who knows what else) made a surprising comeback in the US despite having cures. Scholars are still trying to make sense of it.โ
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