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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.

Oct 2Fri
  1. aacrjournals.org80

    In Regulatory First, Myeloma Drug Approved Based on MRD Negativity

    The FDA has approved iberdomide for multiple myeloma on the basis of minimal residual disease negativity, the first approval for the disease to use that endpoint. Iberdomide also represents a new generation of targeted protein degraders, with several more potent cereblon E3 ligase modulators already in clinical development.

    Why it matters: First myeloma approval based on MRD negativity and a new class of cereblon E3 ligase modulators advancing.

Oct 1Thu
  1. fda.gov61

    FDA approves first drug to improve functional capacity and symptoms in children with rare inherited heart condition

    The FDA approved Camzyos (mavacamten) as the first treatment to improve functional capacity and symptoms in children with symptomatic obstructive hypertrophic cardiomyopathy, extending approval to pediatric patients weighing at least 30 kg, after adult approval in 2022. Efficacy was supported by the phase 3 SCOUT-HCM trial in 44 patients aged 12-18, where once-daily dosing for 28 weeks significantly reduced the Valsalva LVOT gradient versus placebo. The drug carries a boxed warning for heart failure risk and is available only through the Camzyos REMS program.

    Why it matters: First pediatric approval for symptomatic oHCM, backed by phase 3 data in adolescents.

Sep 30Wed
  1. biospace.com40

    GSK laying off 1.2K+ in Belgium

    GSK is laying off more than 1,200 employees in Belgium, part of a wave of biopharma job cuts in 2026 tracked by BioSpace. Other reductions include Novo Nordisk's workforce shrinking by about 13,000 people over the past year to 67,000 as it shifts money into R&D, Takeda cutting over 4,700 jobs, and Bristol Myers Squibb terminating 265 employees at its Princeton, New Jersey site between Dec. 17, 2026 and May 21, 2027. Layoffs tied to M&A include BioNTech letting go of around 800 people at CureVac.

Sep 22Tue
  1. Nature Medicine52

    Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial

    A phase 1b/2 trial tested trastuzumab combined with nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer. The regimen showed encouraging clinical response rates, and HER2 expression was associated with clinical benefit. The results support HER2 status as a marker guiding trastuzumab-based treatment in this population.

    Why it matters: First data on adding trastuzumab and nivolumab to standard gemcitabine-cisplatin in HER2-positive biliary tract cancer.

Sep 4Fri
  1. nature.com65

    Newest glue degrader nabs multiple myeloma approval

    Bristol Myers Squibb won accelerated approval for iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase (Darzalex Faspro) and dexamethasone for multiple myeloma patients who have received at least one prior line of therapy. Iberdomide is the newest of BMS's molecular glue degraders to reach the market.

    Why it matters: Accelerated approval of a new glue degrader expands the multiple myeloma treatment landscape.

Sep 3Thu
  1. fiercebiotech.com64

    GSK pens $1.3B Hutchmed deal for early-stage KRAS-EGFR cancer asset

    GSK has licensed Hutchmed's preclinical KRAS-EGFR antibody conjugate HMPL-A830, paying $110 million upfront in a deal worth up to $1.295 billion, excluding Mainland China, Hong Kong, Macau and Taiwan. The candidate delivers a KRAS inhibitor to EGFR-expressing tumors and is slated to enter trials later this year, initially in colorectal, pancreatic and lung cancer. Hutchmed will run Phase 1 trials, after which GSK takes over R&D and commercialization outside select Asian territories.

    Why it matters: GSK is paying up to $1.295 billion for a preclinical first-in-class KRAS-EGFR candidate, a notable early-stage oncology licensing deal.

Aug 29Sat
  1. N Engl J Med55

    Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event.

    Adding milvexian, an oral factor XIa inhibitor, to standard antiplatelet therapy within 7 days after an acute coronary syndrome did not reduce recurrent ischemic events. In 14,194 patients followed for a median of 12.2 months, the composite of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 5.4% with milvexian versus 5.1% with placebo (hazard ratio, 1.05; 95% CI, 0.91 to 1.21). The trial was stopped for futility at a planned interim analysis; major bleeding rates were 0.3% in both groups.

    Why it matters: A large phase 3 trial shows factor XIa inhibition with milvexian failed to improve outcomes after acute coronary syndrome.

Aug 25Tue
  1. JAMA75

    Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial.

    Adjuvant nivolumab after upfront surgery did not improve disease-free survival in resected non-small cell lung cancer. Median disease-free survival was 71.3 months with nivolumab vs 68.8 months with observation (hazard ratio, 0.97; 1-sided P = .39), and the trial was stopped for futility. This contrasts with the established benefit of preoperative and perioperative nivolumab in this setting.

    Why it matters: A negative phase 3 trial clarifies that adjuvant nivolumab adds no benefit after upfront surgery in resected NSCLC.

Aug 21Fri
  1. Nature66

    Biomarkers of nivolumab benefit in resectable non-small cell lung cancer.

    Pre-surgical ctDNA clearance identifies patients most likely to benefit from perioperative nivolumab in resectable NSCLC: 66% of nivolumab-treated patients with evaluable ctDNA cleared it before surgery, and half of those had pathologic complete response, versus 38% clearance and 12% pCR on placebo. Nivolumab also prolonged EFS in patients with alterations in KEAP1, STK11, CDKN2A and/or SMARCA4 (HR 0.48, 95% CI 0.28-0.83). A machine-learning model ranked ctDNA clearance among top predictors of longer EFS.

    Why it matters: Defines ctDNA-based markers that predict benefit from perioperative nivolumab in resectable NSCLC.

  2. fiercepharma.com47

    Xspray's Dasynoc approval bid foiled again by FDA's manufacturer concerns

    The FDA has issued Xspray Pharma a third Complete Response Letter for Dasynoc, its optimized version of Bristol Myers Squibb's Sprycel (dasatinib) for chronic myeloid leukemia and acute lymphoblastic leukemia. The letter cites manufacturing observations at third-party producer NerPharMa in Italy and requests additional commercial-scale batch data; the FDA has yet to decide whether a reinspection is needed. Xspray plans to resubmit the application before the end of the year and continues U.S. launch preparations.

Aug 14Fri
  1. STAT News81

    STAT+: FDA approves Bristol multiple myeloma treatment, marking debut of novel drug class

    The FDA approved Bristol Myers Squibb's oral drug iberdomide, branded Zenbexus, for advanced multiple myeloma in patients who have received at least one prior line of therapy. It is the first drug in a new class of medicines for the blood cancer and the first cleared using a more sensitive measure of remission. Zenbexus will be used in combination with Darzalex and dexamethasone, and Bristol sees the class opening possibilities for more combinations.

    Why it matters: First approval of a novel drug class for multiple myeloma, with a new remission standard used by FDA.

  2. FiercePharma48

    It's BMS vs. Celgene investors once more after US appeals court revives lawsuit

    A U.S. appeals court in Manhattan has revived a lawsuit by Celgene shareholders who accuse Bristol Myers Squibb of deliberately slowing the FDA approval of Breyanzi to avoid paying more than $6 billion under a contingent value rights deal tied to its $74 billion acquisition of Celgene in 2019. The 3-0 ruling overturned Judge Jesse Furman's 2024 dismissal and found that trustee UMB Bank can maintain the suit because BMS accepted its appointment. A related breach-of-contract case was allowed to proceed in part in December, and it is uncertain how the decision affects it.

  3. FiercePharma82

    BMS bags first FDA approval for CELMoD franchise with Zenbexus multiple myeloma nod

    The FDA has granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide), the first cleared CELMoD therapy, in combination with Johnson & Johnson's Darzalex and dexamethasone for adults with previously treated multiple myeloma. The approval rests on the phase 3 Excaliber-RRMM trial, where the regimen achieved an MRD-negative complete response rate of 41% versus 21% for Darzalex, Velcade and dexamethasone at a median follow-up of 16 months. BMS must provide confirmatory PFS data expected this year, and its second CELMoD, mezigdomide, faces an FDA decision date of May 13, 2027.

    Why it matters: First approval for a CELMoD drug and first new myeloma drug cleared directly on MRD as an endpoint.

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