1. Cosentyx® fails to show statistically significant benefits in giant cell arteritis: On Jul 03, 2025, Norvatis announced results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA). Cosentyx® selectively blocks IL-17A, which is an important cytokine involved multiple inflammatory diseases. In the study, Cosentyx® was combined with a steroid taper for 26 weeks and compared to the group treated with placebo and a 52-week steroid taper. The combination of Cosentyx® and steroid taper did not show statistically significant improvement in sustained remission over the placebo combination. But there is a numerically but not statistically improved cumulative steroid dose and steroid-related toxicity superiority in the Cosentyx® combination group.
Link: https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-gcaptain-study-cosentyx-giant-cell-arteritis-gca
2. Imfinzi-based therapy approved in the E.U. for resectable bladder cancer: On Jul 03, 2025, AstraZeneca announced that Imfinzi (durvalumab) has been approved in the EU for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy.
The Imfinzi-based regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 32% versus chemotherapy plus surgery. Median event-free survival was not reached for the Imfinzi arm versus 46.1 months for the comparator arm. At two years, 67.8% were event-free and 82.2% were alive, compared to 59.8% and 75.2% in the control group. The key secondary endpoint of overall survival was improved, with a 25% reduction in the risk of death.
Link: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-eu-for-bladder-cancer.html
3. Bemarituzumab plus chemotherapy improves overall survival in FGFR2b+ gastric cancer patients: On Jun 30, 2025, Amgen announced results from the Phase 3 FORTITUDE-101 study evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) in fibroblast growth factor receptor 2b (FGFR2b) positive gastric cancer patients. FGFR2b protein is a biomarker associated with tumor cell proliferation. Results showed bemarituzumab plus chemotherapy significantly and clinically improved overall survival (OS) as compared to placebo plus chemotherapy.
Link: https://www.amgen.com/newsroom/press-releases/2025/06/amgen-announces-positive-topline-phase-3-results-for-bemarituzumab-in-fibroblast-growth-factor-receptor-2b-fgfr2b-positive-firstline-gastric-cancer
4. mRNA-1010 flu vaccine shows superior efficacy over standard-dose vaccine in adults aged 50 plus: On Jun 30, 2025, Moderna announced positive results from a Phase 3 P304 study evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010 compared to a standard-dose seasonal influenza vaccine in adults aged 50 years and older. mRNA-1010 achieved the superiority criterion prespecified in the protocol, with an rVE of 26.6% in the overall study population. Additionally, strong efficacy was observed for specific influenza strains contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%).
Link: https://investors.modernatx.com/news/news-details/2025/Moderna-Announces-Positive-Phase-3-Results-for-Seasonal-Influenza-Vaccine/default.aspx
5. FDA approves low-IgA GAMMAGARD LIQUID ERC for patients lack of IgA: On June 30, 2025, Takeda announced that the U.S. FDA has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution as replacement therapy for people two years of age and older with primary immunodeficiency (PI) with low IgA content. In parallel to this approval, Takeda has decided to discontinue GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution.
Link: https://www.takeda.com/newsroom/newsreleases/2025/gammagard-immunoglobulin/
6. FDA grants accelerated approval to Lynozyfic™ for heavily pretreated relapsed or refractory multiple myeloma: On July 2, 2025, Regeneron Pharmaceuticals announced that the U.S. FDA has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy. Lynozyfic is an FDA-approved BCMAxCD3 bispecific antibody dosed every two weeks starting at week 14. Lynozyfic was granted accelerated approval and the approval was based on results from the Phase 1/2 LINKER-MM1 trial. The objective response rate (ORR) was 70%, with 45% achieving a complete response (CR) or better. It takes an average of 0.95 months to reach the first response. The estimated duration of response (DoR) was 89% at 9 months and 72% at 12 months among responders who had a median follow-up of 13 months.
Link: https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval
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