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  • FDA opens investigation into Novartis' Zolgensma after cancer cases reported
    The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The a…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 2d agoApprovalPositive↗ source
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Nephrology735
  • Immunocore reports early data showing 70% two-year survival with brenetafusp/Kimmtrak combo in uveal melanoma
    Immunocore presented early clinical data on its bispecific T-cell engager combination brenetafusp and Kimmtrak in patients with uveal melanoma. The analysis, based on a subset of patients, indicat…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 2d agoEarningsPositive↗ source
  • Moderna pauses norovirus vaccine trial after missing interim analysis
    Moderna announced it will not enroll a new cohort in the phase 3 trial of its mRNA-1403 norovirus vaccine. The decision follows a July interim analysis that showed the vaccine missed its predefine…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Merck ends Sutro partnership on IL-2 agonist MK-1484 amid routine pipeline prioritization
    Merck announced it is discontinuing development of MK-1484, an interleukin-2 agonist created in partnership with Sutro Biopharma. The drug entered clinical testing in 2022 as a monotherapy and in…
    Fierce Biotech · 3d agoNegative↗ source
  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 3d agoNeutral↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source
  • Seven new tumor cases reported among patients on Novartis' Zolgensma gene therapy
    Nine patients who have received Novartis' spinal muscular atrophy gene therapy Zolgensma have developed tumors following their treatment, the company confirmed Thursday. Seven of those cases were d…
    Endpoints · 3d ago↗ source
  • Boehringer Ingelheim partners with Sino Biopharma on $7 billion cancer drug deal
    Boehringer Ingelheim announced a partnership with China's Sino Biopharmaceutical to co-develop cancer therapies. The agreement targets antibody-drug conjugates and T-cell engager platforms, with a…
    Endpoints · 4d agoDealPositive↗ source
  • Boehringer Ingelheim strikes $7.4 billion deal with Sino Biopharma for preclinical ADC and TCE programs
    Boehringer Ingelheim announced a major licensing agreement with China's Sino Biopharmaceutical, paying $358 million upfront for a six‑program option covering preclinical antibody‑drug conjugates an…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Servier’s $1.55 B Edgewise muscular dystrophy trial fails to meet primary and secondary endpoints
    Servier invested roughly $1.55 billion in Edgewise Therapeutics' muscular dystrophy program and, five months after the deal, announced that the pivotal phase 2 trial in Becker muscular dystrophy di…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • AbbVie pays $100M upfront in $1.4B deal for Nxera's phase-1 IBD candidate
    AbbVie has agreed to pay $100 million upfront for the worldwide rights to Nxera's oral EP4 receptor agonist, designated NXE0033744, with the total deal value potentially reaching $1.4 billion throu…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Charles River partners with Ipsen to employ virtual control groups in toxicology studies
    Charles River Laboratories and French biopharma Ipsen announced a collaboration to use Charles River’s virtual control group (VCG) database in an upcoming toxicology study. The VCG approach aims t…
    Fierce Biotech · 4d agoDealPositive↗ source
  • Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer study
    Spyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…
    Endpoints · 4d agoNegative readoutNegative↗ source
  • Pfizer raises 2026 outlook as oncology and migraine growth balances Covid product decline
    Pfizer announced it has increased its financial guidance for 2026, citing stronger performance in its cancer and migraine divisions. The company said sales of its Covid-19 related products have fa…
    Endpoints · 5d agoEarningsPositive↗ source
  • T-Therapeutics secures $133M Series B to advance TCR-CD3 bispecifics with major pharma investors
    T-Therapeutics announced a $133 million Series B financing round backed by several of the world’s largest drug developers, including Eli Lilly, Johnson & Johnson, Merck KGaA and Sanofi, along with…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Pfizer drops phase 2 pulmonary arterial hypertension candidate amid pipeline cut
    Pfizer has discontinued its phase 2 pulmonary arterial hypertension (PAH) program, PF-07868489, citing business reasons rather than safety or efficacy concerns. The drug, which targets BMP9 inhibi…
    Fierce Biotech · 6d agoNegative↗ source
  • AbbVie commits £120 million to new Oxford R&D hub, boosting UK life‑science footprint
    AbbVie announced a £120 million ($160 million) investment to expand its research footprint in the United Kingdom. The company will open a new 12,000‑square‑foot R&D facility in Oxford, joining its…
    Fierce Biotech · 6d agoDealPositive↗ source
  • AbbVie halts development of livmoniplimab after deeming benefit limited
    AbbVie announced it is discontinuing the phase 2 development of its monoclonal antibody livmoniplimab (ABBV-151) after concluding the drug is unlikely to outperform existing therapies. The drug wa…
    Fierce Biotech · 6d agoNegative↗ source
  • Karyopharm files Chapter 11 and taps Irish biotech Ayrmid as lead bidder for merger
    Karyopharm Therapeutics, a Massachusetts-based biopharma, entered Chapter 11 bankruptcy as part of a plan to merge with Irish hematology biotech Ayrmid. The move follows a cash crisis revealed in…
    Fierce Biotech · 6d agoDealNegative↗ source
  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 6d agoDealNeutral↗ source
  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • AstraZeneca drops two early-phase prostate cancer programs
    AstraZeneca announced it is terminating development of two early-phase prostate cancer candidates, AZD9750 and AZD8359, as part of a quarterly pipeline review. AZD9750, an oral androgen-receptor d…
    Fierce Biotech · 10d agoNegative↗ source