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China competitionDrugs from China are reshaping biotech. Track the licensing deals here.
A potentially $2 billion deal with InnoCare Pharma gives Zenas BioPharma rights to three drugs, including a medicine already in late-stage testing for multiple sclerosis.
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Obesity drugsSkye shares crash as obesity drug falls short in key study
The findings are the latest setback for weight loss medicines that target a specific cannabinoid receptor and are meant to boost the effects of incretin therapies like Wegovy.
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AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer
The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.
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News roundupGilead delays arrival of Biktarvy copycats; CDC updates vaccine schedule
A settlement could extend the exclusivity of the world’s best-selling HIV medicine to 2036. Elsewhere, an AstraZeneca drug acquisition paid more dividends and a Vertex veteran became Stoke’s full-time CEO.
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Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Tracker5 FDA decisions to watch in the fourth quarter of 2025
Against the backdrop of a government shutdown, the agency has a series of critical decisions ahead, among them verdicts on new therapies from Novo Nordisk and Biohaven.
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Deep Dive // Emerging biotechBiotech IPOs are the industry’s lifeblood. Track how they’re performing.
Should it price on the terms outlined Monday, MapLight’s offering would be the third-largest biotech IPO this year and the second consecutive one involving a CNS drug developer.
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Gene editingChiesi buys into Arbor gene editing drug for rare kidney disease
The Italian drugmaker will pay as much as $115 million in upfront and near-term payments in a deal that gives it rights to a treatment in early-stage testing for primary hyperoxaluria type 1.
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Courtesy of Merck
Half of Merck’s sales are in jeopardy. Can Keytruda’s sequel save the day?
Wall Street analysts expect the subcutaneous version of Keytruda, which just launched last week, to help soften the blow when the original loses patent protection later this decade.
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News roundup
FDA clears generic abortion pill; CMS punts ‘combo drug’ guidance
The decision to clear another mifepristone generic sparked political backlash. Elsewhere, investors will pump up to $175 million into Ovid after the company reported early, but encouraging, data for a potential epilepsy drug.
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Amgen claims ‘landmark’ study result that could widen heart drug’s use
In a first-of-its-kind finding, Amgen’s PCSK9 drug protected heart health when tested as a “primary prevention” therapy, which could pave the way for access to a much broader population.
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Adeline Kon/BioPharma Dive/BioPharma Dive
Deep Dive // Emerging biotechBiotech startups are built on venture capital. Track funding rounds here.
Twelve biotechs raised funding rounds in September that involved the firms tracked by BioPharma Dive, the highest number in any month since January.
Updated Oct. 3, 2025 -
Kendall Davis/BioPharma Dive
Tracker10 clinical trials to watch the rest of 2025
Expected readouts in obesity, lung cancer and AATD headline a series of study results that could give the biotechnology sector a boost.
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Deep DiveAI could transform healthcare. Can safety-net providers keep up?
Implementing artificial intelligence requires significant human labor and technical expertise, threatening to create a digital divide between highly resourced health systems and safety-net providers.
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Emerging biotechCartography secures $67M in pursuit of ‘differentiated’ cancer drugs
The company is working on T cell engagers and other multifunctional antibodies, led by a prospect it believes might be helpful treating the vast majority of colorectal cancer cases.
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Takeda, in reversal, abandons cell therapy research
The Japanese pharmaceutical company, which had made cell therapy a priority a few years ago, aims to partner its work while prioritizing investments elsewhere.
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Permission granted by Aerska
Startup launchesA new biotech aims to get RNA drugs into the brain
Dublin-based Aerska launched on Wednesday with $21 million in seed funding and a technology designed to shuttle RNA interference medicines past the blood-brain barrier.
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Courtesy of Galapagos
Galapagos to decide on fate of cell therapy business ‘within weeks’
The company has received a “limited number” of non-binding proposals, mostly from groups of financial investors, for a business that was once its primary focus.
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News roundup
FDA official’s comments spark Aurinia sell-off; Halozyme buys a biotech
George Tidmarsh criticized Aurinia’s lupus drug in a later-retracted social media post. Elsewhere, the FDA approved a new Novartis drug and two biotechs cut staff.
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Trump administrationTrump, Pfizer drug pricing deal short on details, possible impact
A pact to offer “most favored nation” prices to state Medicaid programs and via direct-to-consumer channels doesn’t affect those on commercial insurance or who won’t pay out of pocket.
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Obesity drugsMetsera strengthens case for Pfizer buyout with latest study data
In a Phase 2 trial, a drug at the center of the $4.9 billion deal matched the type of weight loss trajectory seen in testing of Eli Lilly’s Zepbound.
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Startup launchesCrystalys debuts with $205M and plans for a better gout drug
The biotech is starting up with partial rights to a drug that’s approved in multiple Asian countries and its executives see as a superior version of the now-withdrawn gout medication Zurampic.
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Courtesy of GSK Flickr page
Emma Walmsley, big pharma’s first female CEO, to depart GSK
Walmsley, who helped push GSK to focus more exclusively on specialty medicines and oncology, will be succeeded by commercial head Luke Miels on Jan. 1.
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Emerging biotechStar raises another $125M for its blood disease drug
Star hopes its drug, which is currently in late-stage testing, might prove a more convenient, longer-lasting alternative to standard therapies for Von Willebrand disease.
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Moonlake shares crash on mixed study results for immune drug
Anticipated late-stage results in the skin disease hidradenitis suppurativa were described by analysts as “disappointing” and “undifferentiated,” erasing more than four-fifths of the company’s market value.
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Pharma reshoringKey exemptions could limit impact of Trump’s pharmaceutical tariffs
Carve-outs for generics, European exports and companies onshoring drug production will likely shield most branded drugs from the 100% levies Trump announced Thursday.
