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    News roundup

    Another autoimmune CAR-T death; Treasury zeroes in on China deals

    A patient who received Bristol Myers’ zola-cel died 44 days later. Elsewhere, Gilead paid nearly $1.3 billion for a potential threat to J&J’s newly approved psoriasis pill.

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    Sponsored by Cytiva

    Novel protein and peptide therapeutics

    Explore manufacturing challenges and solutions for ADCs, bispecifics, peptides and more.

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    Moderna, Merck shares fall on eagerly anticipated cancer vaccine results

    A combination of the shot and the immunotherapy Keytruda cut the risk of relapse or death by 42% in a landmark melanoma study that met Wall Street expectations but triggered a “sell-the-news reaction,” one analyst wrote.

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    This week in charts: a big year for RNAi developers

    The latest installment in BioPharma Dive’s data visualization series features a look at the emerging popularity of RNAi developers, and the funding that came with it.

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    BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study

    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.

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    Deep Dive // IPO window

    Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

    Windward Bio, a Novo Holdings and OrbiMed-backed immune drugmaker built around medicines in-licensed from China, joined a handful of other biotechs that have revealed IPO plans this month.

    Updated Oct. 26, 2026
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    Star adds $200M after spinout successes

    Following exits for its subsidiaries Electra Therapeutics and Vega Therapeutics, Star is now mining for a new drug prospect.

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    IPO window

    Protein degrader specialist Lycia prices $318M IPO

    Funds from the upsized offering will support a trio of protein-degrading medicines in development for allergic conditions as well as the autoimmune disorder Graves’ disease.

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    Roche affirms sales outlook amid doubts about its future

    Lower-than-expected sales of Xolair stood out as the Swiss drugmaker readies for an onslaught of generic competition for top products. 

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    Biohaven’s previously rejected rare disease drug to get fresh FDA review

    U.S. regulators have accepted a new submission for Vyglxia, offering the chance at a turnaround for another rare disease medicine spurned by previous FDA leadership.

    FDA
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    GSK, Ionis win US approval for first-of-its-kind hepatitis B drug

    Hibsago is viewed as a potential “functional cure” for chronic infections and an important part of the British drugmaker’s goal of reaching £40 billion in annual revenue by 2031.

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    Most new drugs are still too costly at launch, ICER says

    A new analysis from the non-profit group found that net launch prices for new medicines spiked significantly between 2022 and 2025, and the majority were well above its cost-effectiveness guidelines.  

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    Deep Dive

    Biotech M&A is accelerating. Track the deals that are happening here.

    The 130% premium in Merck KGaA’s buyout of Silence Therapeutics is the second-highest paid in a biopharmaceutical company purchase this year, according to BioPharma Dive data.

    Updated Oct. 19, 2026
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    Obesity drugs

    GLP-1 compounder issues recall for copycat Zepbound

    The notice adds to growing concerns about the safety of knockoff weight loss drugs, which have remained popular despite FDA warnings and legal pressure from Eli Lilly and Novo.

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    Roivant, continuing ascent, claims another victory for rare disease drug

    Shortly after winning a clearance in the skin disease dermatomyositis, brepocitinib posted results suggesting it might also be a “best-in-disease” medicine for an inflammatory eye condition, one analyst said.

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    News roundup

    Arcus kidney cancer data impresses analysts; TriGemX inks a SPAC deal

    New follow-up results suggest Arcus’ drug might be superior to a marketed Merck medicine. Elsewhere, Eli Lilly and AstraZeneca forged new partnerships.

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    China competition

    Drugs from China are reshaping biotech. Track the licensing deals here.

    Including its latest deal with Rona Therapeutics, Roche has now inked 10 licensing pacts with China-based drugmakers since the start of 2025. Five have come since late August.

    Updated Oct. 13, 2026
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    Rapport’s epilepsy drug finds surprising success in bipolar trial

    Despite what some analysts described as low expectations, RAP-219 narrowly hit the main goal of a mid-stage study, results that could help it tap a billion-dollar-plus market opportunity.

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    Merck KGaA bets on RNAi with $1.3B Silence buyout

    The acquisition gives the German company a promising blood disorder medicine that passed a Phase 2 test and could threaten a Takeda drug.

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    Hype vs. reality: What pharma’s hottest R&D bets have actually proved

    New types of bispecifics, antibody-drug conjugates and cell therapies haven’t yet proven themselves in the clinic. Pharmaceutical companies are betting billions anyway.

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    Q&A // IPO window

    Iambic CEO on taking an AI drug company public

    Fresh off a $150 million IPO, Tom Miller spoke to BioPharma Dive about the roadshow process and how he sees AI’s role in drug development evolving.

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    Disc’s once-spurned rare disease drug to get a second chance at approval

    Months after the FDA rejected its treatment for a rare light-sensitivity disease, the biotech claimed success in a Phase 3 trial and now plans to re-engage regulators.

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    News roundup

    Roche inks $15B ADC pact with Hansoh; Veradermics scores in another baldness study

    Roche is paying Hansoh $400 million up front in a broad deal involving several ADCs. Elsewhere, another top investor formed a China-focused fund and Ultragenyx sold a second review voucher.

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    This week in charts: Moderna’s massive stock run

    The latest installment in BioPharma Dive’s data visualization-focused series includes a look at Moderna’s meteoric rise in 2026 and a sudden deal surge from Roche.

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    Trump administration

    FDA ‘reset’ continues with new plan for reviewing rare disease drugs

    A revamped regulatory framework may give investors less of a “guessing game” as they weigh chances for drug approvals, one analyst said.

    FDA
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    IPO window

    Next-gen RNAi drugmaker City prices $200M IPO

    The offering will support a trio of medicines in or nearing clinical testing, as well as earlier research into RNAi treatments that get into tissues outside the liver.