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185 stories matching this filter · ← front page

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  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 22h agoDealPositive↗ source
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 4d agoPositive↗ source
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  • Verastem reports promising early results for KRAS G12D inhibitor in pancreatic and lung cancers
    Verastem Oncology has shifted its research toward a KRAS G12D inhibitor, VS-7375, and released early data from a phase 1/2 study involving more than 200 patients with advanced KRAS G12D-mutated sol…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • Gilead signs $1.9 billion deal with Vir Biotechnology to license dual-masked T-cell engagers for oncology
    Gilead Sciences announced a licensing agreement with Vir Biotechnology to access Vir's dual-masked PRO-XTEN T-cell engager platform for oncology. Under the deal, Vir will discover, design and opti…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Paragon Labs hires former Apogee leadership after AbbVie acquisition and spins out hypertension unit
    Paragon Labs announced it has brought several former Apogee Therapeutics executives onto its senior team following AbbVie's $10.9 billion purchase of Apogee. The incoming leaders include Michael H…
    Fierce Biotech · 6d agoDealNeutral↗ source
  • Syndax halts development of Niktimvo after Phase 2 failure in IPF trial
    Syndax announced it is stopping work on its experimental drug Niktimvo for idiopathic pulmonary fibrosis (IPF) after the compound did not meet its primary endpoints in a placebo-controlled Phase 2…
    Endpoints · 6d agoNegative readoutNegative↗ source
  • BMS reports phase 3 successes in IPF drug and neuroendocrine tumor radiotherapy
    Bristol Myers Squibb announced that two of its phase 3 trials have met primary endpoints, marking important milestones as the company seeks growth beyond its patent expirations. The Aloft-IPF stud…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Bristol Myers reports two Phase 3 successes for fibrosis and RayzeBio drug
    Bristol Myers Squibb announced Monday that two of its late-stage trials have met primary endpoints. The first trial involved its fibrosis program, where the experimental therapy demonstrated the e…
    Endpoints · 7d agoPositive readoutPositive↗ source
  • Parkinson’s-focused Aspen and bispecific biotech Bambusa plan IPOs
    Parkinson’s disease cell therapy-focused Aspen Neuroscience and bispecific biotech Bambusa Therapeutics are the latest drug developers to eye up a public listing.
    Fierce Biotech · 9d ago↗ source
  • Endeavor BioMedicines reports positive phase 2b results for Hedgehog inhibitor taladegib in IPF
    Endeavor BioMedicines announced that its Hedgehog pathway inhibitor, taladegib, produced encouraging results in a phase 2b study of patients with idiopathic pulmonary fibrosis (IPF). The trial, nam…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • Endeavor BioMedicines reports mid-stage trial success for IPF drug, suggests disease reversal potential
    Endeavor BioMedicines announced that its experimental therapy for idiopathic pulmonary fibrosis has met its primary goals in a Phase 2 study. The company said the mid‑stage trial showed signs that…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 13d agoNegative readoutNegative↗ source
  • ArriVent's lead lung cancer drug firmonertinib fails Phase 3 trial, shares plunge
    ArriVent BioPharma announced that its flagship EGFR inhibitor, firmonertinib, did not meet primary endpoints in a late-stage Phase 3 study for lung cancer. The trial results were released on Octobe…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • ArriVent’s phase 3 EGFR inhibitor trial misses primary endpoint, shares plunge 57%
    ArriVent BioPharma reported results from its phase 3 Furvent trial, which evaluated firmonertinib, a brain-penetrant EGFR inhibitor, in patients with exon 20 insertion-mutated non-small cell lung c…
    Fierce Biotech · 13d agoNegative readoutNegative↗ source
  • Abbott receives FDA clearance for CardioMEMS HF System updates enabling home pressure monitoring via smartphone app
    Abbott announced that the U.S. Food and Drug Administration has cleared updated software for its CardioMEMS HF System. The changes add a patient facing component through the CardioGuide HF mobile a…
    Fierce Biotech · 13d agoApprovalPositive↗ source
  • AstraZeneca opens 570,000-sq-ft Kendall Square R&D hub to boost cancer and biotech research
    AstraZeneca inaugurated a 570,000-square-foot research and development facility in Kendall Square, Cambridge, Massachusetts. The 18-story building will host roughly 2,000 scientists working on chr…
    Fierce Biotech · 14d agoPositive↗ source
  • FDA approves first expandable pediatric pulmonary heart valve
    The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease. The device, called the Autus Size-Adjustable Valve, was developed by E…
    Fierce Biotech · 15d agoApprovalPositive↗ source
  • Genmab’s Rina-S ADC shows 9.5-month median PFS, touted as superior to AbbVie’s Elahere
    Genmab reported median progression‑free survival of 9.5 months for its FRα‑directed antibody‑drug conjugate Rina‑S in part C of the phase 1/2 Rainfol‑01 trial, which enrolled 109 patients with plat…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 18d agoApprovalPositive↗ source
  • Sanofi pays Regeneron $1 billion upfront to co-develop four early-stage immunology assets
    Sanofi has agreed to pay Regeneron an upfront fee of $1 billion to partner on four early‑stage immunology programs, a move intended to capture the success of their joint Dupixent antibody. Dupixen…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Foghorn Therapeutics cuts 40% of staff after Lilly partnership ends over weak phase-1 data
    Foghorn Therapeutics announced it will lay off 40% of its workforce after its long‑standing collaboration with Eli Lilly fell apart due to disappointing phase‑1 trial results. The partnership, lau…
    Fierce Biotech · 18d agoLayoffsNegative↗ source
  • BMS trial sees patient death, analysts say drug mechanism still viable
    Bristol Myers Squibb is running a phase 3 study of an LPA1 inhibitor, admilparant, for idiopathic and progressive pulmonary fibrosis. A patient death was reported after the trial was amended to inc…
    Fierce Biotech · 18d agoNeutral↗ source
  • Bayer names Christoph Koenen as new chief medical officer as Eric Cantor becomes PhRMA CEO
    Bayer announced that Christoph Koenen, M.D., has been appointed as its new chief medical officer. Koenen, who joined Bayer in 2022 after roles at Bristol Myers Squibb, Novo, Boehringer and GSK, wil…
    Fierce Biotech · 18d agoNeutral↗ source
  • Patient death raises safety concerns before Bristol Myers lung drug readout
    A patient died from a fatal liver injury while taking part in a trial of Bristol Myers Squibb's lung disease candidate. The company disclosed the incident in a May amendment to its trial documents…
    Endpoints · 19d agoNegative↗ source
  • Connect Biopharma's IL-4/IL-13 blocker cuts COPD exacerbations by 85% in Phase 2 trial
    Connect Biopharma reported phase 2 results for its IL-4/IL-13 inhibitor rademikibart in COPD patients. In the Seabreeze STAT study of 159 participants who had recent exacerbations, adding rademiki…
    Fierce Biotech · 19d agoPositive readoutNeutral↗ source