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Oct 1Thu
  1. BioCentury59

    I-DXd withdrawal thins October PDUFA calendar

    Merck & Co. and Daiichi Sankyo withdrew their BLA for ifinatamab deruxtecan two weeks before its PDUFA date; the partners had sought accelerated approval for extensive-stage small cell lung cancer in patients whose disease progressed on platinum chemotherapy. The withdrawal leaves at least five FDA decisions on the PDUFA calendar for October. The article does not state what the companies plan to do next with the programme.

    Why it matters: A BLA withdrawal by Merck and Daiichi Sankyo cuts October's expected FDA decision count to five.

Sep 30Wed
  1. biospace.com50

    Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC

    Merck and Daiichi Sankyo have voluntarily withdrawn their accelerated approval application for the antibody-drug conjugate ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer after platinum-based chemotherapy, after the FDA said the data did not satisfy requirements for the proposed indication. The application rested on a 48.2% confirmed objective response rate from the Phase 2 IDeate-Lung01 study. A Phase 3 trial in ES-SCLC with enrollment nearing completion continues and could support a future filing.

    Why it matters: Voluntary withdrawal of an accelerated approval application narrows the regulatory path for a key Merck-Daiichi Sankyo ADC.

Sep 28Mon
  1. biopharmadive.com56

    Merck, Daiichi end plans to seek speedy approval of lung cancer ADC

    Merck & Co. and Daiichi Sankyo withdrew their U.S. application for accelerated approval of ifinatamab deruxtecan, or I-DXd, in extensive-stage small-cell lung cancer after the FDA indicated Phase 2 response rate data were insufficient; a decision had been expected by Oct. 10. The B7-H3-targeting drug is still being tested against chemotherapy in relapsed disease, a trial in which recruitment was temporarily halted last year after higher than anticipated deaths from a serious lung condition. Competing B7-H3 drugs licensed to GSK (riz-rez) and Roche (tam-peli) have advanced, and I-DXd is also in Phase 3 testing in prostate cancer and esophageal squamous cell carcinoma.

    Why it matters: A rejected accelerated approval reshapes the B7-H3 race in small-cell lung cancer among Merck, GSK and Roche.

  2. bsky.app47

    Signal or noise? > Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal >> Comment below! #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #healthcare #competitivemarketing

    Merck and Daiichi have withdrawn a lung cancer filing after pushback from the FDA. The withdrawal deals another blow to their $4 billion deal. No further trial details, drug name or next steps were given in the available material.

Aug 24Mon
  1. FiercePharma56

    Merck, AZ lawsuits against Medicare price negotiations swatted down

    The U.S. Court of Appeals for the Third Circuit rejected Merck's claim that the CMS Medicare drug price negotiation program under the Inflation Reduction Act violates the First and Fifth Amendments, with Judge Colleen Kollar-Kotelly ruling companies can choose whether to participate. Five days earlier, a federal court in Maryland dismissed an AstraZeneca suit over how CMS grouped its drugs for eligibility. The rulings extend a string of losses for drugmakers since 2022, though Teva won a partial reversal last week when an appeals court sent its case back to District Court.

Aug 14Fri
  1. BioCentury40

    Global drugs that made the grade in China in 2025

    China's NMPA approved 60 drugs and vaccines in 2025 that were already marketed abroad, with a median first-approval year of 2019. Merck & Co. holds marketing authorizations for five of the 60 products, including two vaccines, the most among importers. Most other multi-product sponsors are large multinational pharmas, with Almirall and UCB the two specialty European companies included.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org