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Oct 13Tue
  1. biopharmadive.com40

    Bausch + Lomb swaps CEOs; Merck reveals anticipated eye drug data

    Bausch + Lomb named board chair Thomas Appio interim CEO after he and Brent Saunders mutually agreed to Saunders' exit, and raised its 2026 earnings outlook. Merck disclosed that proliferative diabetic retinopathy adverse events occurred in 6.7% and 6.1% of remigromig patients versus 0.9% on Lucentis, with the drug not superior on secondary measures. Amgen and AstraZeneca reported nearly 70% of eosinophilic esophagitis patients on Tezspire's highest dose were in remission at 24 weeks; the FDA also approved Asahi Kasei's Hovilpri.

    Why it matters: CEO change at Bausch + Lomb plus pivotal safety and efficacy data on remigromig, Tezspire and a new HSV approval.

Oct 12Mon
  1. biopharmadive.com56

    Pharma’s $500B patent problem will come in waves — not as a cliff

    Evaluate forecasting data from Norstella show more than $500 billion in worldwide prescription drug sales at risk from generic competition between 2026 and 2032, with the largest single-year exposure of $158 billion in 2031. Merck is most exposed near term as Keytruda nears expiry in 2028, a year with $99 billion in sales at risk, while AbbVie faces roughly $50 billion of exposure in 2032 when Rinvoq and Skyrizi lose protection. Patent-exposed companies have responded with dealmaking since the start of 2024, led by Merck's six deals totalling $30.9 billion and Lilly's $27.2 billion across nine.

    Why it matters: Quantifies the multiyear patent-expiry risk facing major drugmakers and the dealmaking it is already driving.

Oct 9Fri
  1. biospace.com58

    Merck barred from making subcutaneous Keytruda in 8 European countries

    A Dutch court has barred Merck from producing, importing, stocking or selling Keytruda SC, the subcutaneous formulation of Keytruda, in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands, after finding it infringes a Halozyme Therapeutics patent covering MDASE technology. The decision follows a German preliminary injunction in December, and Merck's appeal of that ruling has a hearing expected next month. Subcutaneous Keytruda brought in $463 million of the franchise's $8.4 billion in second-quarter sales, and a key patent expires in 2028.

    Why it matters: Patent rulings now block subcutaneous Keytruda in key European markets, affecting Merck's strategy ahead of the 2028 patent expiry.

Oct 8Thu
  1. biospace.com40

    Q3 layoffs down YOY, with 90% fewer biopharma employees affected

    BioSpace tallies show biopharma layoffs fell sharply year over year in Q3, with a 56% drop in companies making or projecting cuts and a 90% plunge in affected employees; the 27 companies and 2,568 people affected are the lowest quarterly figures since tracking began in 2024. Eight Big Pharma companies accounted for cuts of 1,845 employees in the quarter, including Bristol Myers Squibb letting go of 265 people in Princeton, New Jersey, GSK closing a German vaccine site with about 650 job losses, and Novartis, whose 2026 disclosures total at least 922 people. Novo CEO Mike Maziar Doustdar said overall headcount has dropped by 13,000 over the past year, including 9,000 layoffs under a restructuring announced in September 2025 targeting around $1.25 billion in annualized savings.

  2. biopharmadive.com40

    Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial

    A Netherlands court blocked sales of Merck's subcutaneous Keytruda Qlex in eight European countries, siding with Halozyme in a patent dispute over its under-the-skin drug delivery technology. Separately, Enliven Therapeutics reached agreement with the FDA on a late-stage trial of relcobitinib in chronic myeloid leukemia, enrolling 450 people to test superiority at spurring a major molecular response. Halozyme is also challenging Merck in a U.S. court after a win in Germany.

    Why it matters: Patent ruling blocks subcutaneous Keytruda across Europe and FDA-aligned CML trial design sharpens competition for Novartis and Merck.

Oct 7Wed
  1. statnews.com53

    STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

    A Dutch court ruled that Merck infringed a Halozyme Therapeutics patent covering a subcutaneous formulation of Keytruda and ordered the company to stop manufacturing and marketing that version in several European countries, including France, Italy, Sweden, Switzerland and the Netherlands. The decision is part of a widening patent dispute over the cancer treatment. Patients can still access the intravenous version, which is unaffected by the order. Merck was asked for comment.

    Why it matters: Court-ordered halt of a subcutaneous Keytruda formulation affects sales in several European markets.

Oct 3Sat
  1. N Engl J Med73

    Phase 3 Trial of Weekly Oral Islatravir-Lenacapavir for HIV-1 Treatment.

    Once-weekly oral islatravir-lenacapavir maintained viral suppression as well as once-daily bictegravir-emtricitabine-tenofovir alafenamide in a phase 3 trial of 607 adults with virologically suppressed HIV-1. At week 48, HIV-1 RNA of 50 copies per milliliter or higher was reported in no ISL/LEN participants and 1 (0.3%) on B/F/TAF, meeting a 4-percentage-point noninferiority margin. The finding supports a long-acting weekly oral option for suppressed patients.

    Why it matters: Phase 3 data show a weekly oral HIV regimen can replace daily tablets without loss of suppression.

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.

  3. endpoints.news41

    Merck licenses a KRAS G12D inhibitor for $400M upfront

    Merck is licensing a KRAS G12D inhibitor from entrepreneur and synthetic chemist Tao Hu for $400 million upfront. Hu previously sold a different KRAS G12D inhibitor to AstraZeneca in 2023. Terms beyond the upfront payment and next steps were not disclosed.

    Why it matters: Large upfront licensing deal for a KRAS G12D inhibitor by a repeat seller of such assets.

  4. statnews.com40

    STAT+: Merck discontinues a crucial antibiotic despite concerns over superbug resistance

    Merck has stopped supplying Recarbrio in the U.S., a three-drug combination antibiotic injection approved seven years ago for serious infections in adults and children, including hospital- or ventilator-associated pneumonia and complicated urinary tract and stomach infections in patients with limited or no treatment options. The company did not explain the decision and did not disclose Recarbrio sales in its regulatory filings. The FDA had designated the drug a treatment of last resort to mitigate antibiotic resistance, which limited its market potential.

    Why it matters: A large drugmaker withdrawing a last-resort antibiotic revives concern about industry commitment to antibiotics amid resistance.

Sep 29Tue
  1. BioCentury68

    Merck turns to China-based SciBrunch for KRAS program, pays $400M up front: Deals Report

    Merck & Co. has licensed global rights to SPR2015, a preclinical KRAS G12D molecular glue inhibitor from China-based SciBrunch, paying $400 million up front. The deal follows reported failed M&A negotiations with Revolution Medicines in the $30 billion range, after that company reported in April that daraxonrasib led to a survival benefit in pancreatic cancer patients. Further deal terms for the SciBrunch agreement were not disclosed.

    Why it matters: Large upfront licensing payment by Merck for a preclinical KRAS G12D program after failed Revolution Medicines talks.

Sep 28Mon
  1. biospace.com45

    Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor

    Merck has licensed exclusive global rights to SciBrunch Therapeutics' preclinical oral KRAS G12D (ON) inhibitor SPR2015, paying $400 million upfront with milestone payments that could bring the total to $2.13 billion. The deal has closed, and Merck recorded a pre-tax charge of $400 million, about 13 cents per share, in Q3. SciBrunch expects SPR2015 to enter human trials by the end of this year. The same day, Merck and Daiichi Sankyo withdrew an accelerated approval request for ifinatamab deruxtecan in extensive-stage small cell lung cancer after the FDA said the data did not support the filing.

    Why it matters: Large licensing deal for a preclinical KRAS G12D inhibitor plus a withdrawn FDA filing shapes Merck's oncology pipeline.

  2. 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.

  3. 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.

Sep 2Wed
  1. fiercebiotech.com48

    Is Moderna, Merck's mRNA cancer vaccine win the start of a 'personalized medicine revolution'?

    Merck & Co. and Moderna reported in August that their individualized mRNA cancer vaccine intismeran autogene (V940, mRNA-4157) plus Keytruda significantly improved recurrence-free survival and distant metastasis-free survival versus Keytruda alone in the phase 3 INTerpath-001 trial of 1,137 patients with resected cutaneous melanoma. Detailed data are being held for a future medical meeting, and analysts and academics say the result has revived interest in mRNA-based personalized cancer vaccines. Moderna's stock closed up 177% on the news.

Aug 31Mon
  1. Lancet68

    Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial.

    Belzutifan plus lenvatinib extended progression-free survival over cabozantinib in previously treated advanced clear-cell renal cell carcinoma. In the phase 3 LITESPARK-011 trial, 747 patients with disease progression after anti-PD-1 or anti-PD-L1 therapy were randomly assigned to belzutifan-lenvatinib or cabozantinib. Progression-free survival by masked independent central review was significantly longer with belzutifan-lenvatinib, while overall survival did not differ significantly, and the authors suggest belzutifan-lenvatinib may become a new standard of care in this setting.

    Why it matters: Phase 3 data on a potential new standard of care after checkpoint inhibitor therapy in advanced clear-cell renal cell carcinoma.

  2. Lancet73

    Switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for HIV-1 (ISLEND-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial.

    Switching virologically suppressed adults with HIV-1 to a once-weekly, single-tablet regimen of islatravir (2 mg)-lenacapavir (300 mg) was non-inferior to continuing daily oral standard of care in the phase 3 ISLEND-2 trial. At week 48, HIV-1 RNA viral load of 50 copies per mL or higher occurred in 1 of 314 participants on islatravir-lenacapavir versus 4 of 312 on standard of care, meeting the non-inferiority margin of 4%. Treatment-related adverse events occurred in 18% of the islatravir-lenacapavir group versus fewer than 1% of the standard-of-care group, though discontinuations due to adverse events were rare in both groups.

    Why it matters: Phase 3 data support the first once-weekly complete oral single-tablet regimen for HIV-1 treatment.

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.

  2. fiercepharma.com47

    Daiichi Sankyo promotes Ken Keller to lead new commercialization unit

    Daiichi Sankyo has promoted Ken Keller, who has led its global oncology business for five years, to chief commercialization officer of a new globally integrated commercialization unit starting April 1. The restructured organization covers five regions, with internal appointments including Yuichi Yomasu in China, Markus Kosch in Europe, Marcelo Goncalves in Latin America, Kenji Shigeta in North America and Nobuo Murakami in Japan, Asia and the Pacific. The unit supports Daiichi Sankyo's plan to become a top-five oncology company by 2035 and to make five drugs available in 20 new indications by 2030.

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