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584 stories matching this filter · ← front page

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  • Hengrui secures $15.2 billion Bristol Myers deal and pivots to co-development with Western partners
    Hengrui Pharmaceuticals has become a leading source of innovative drugs in China, outpacing many peers in the current licensing boom. In May the company signed a $15.2 billion licensing pact with…
    Fierce Biotech · 14d agoDealPositive↗ 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 · 15d agoPositive readoutPositive↗ source
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  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda recalls · 14d agoRegulatoryNegative↗ 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 · 14d agoPositive readoutPositive↗ source
  • Rare disease biotech firms expand teams as FDA approvals boost pipelines
    Several biotech companies focused on rare diseases are actively hiring, offering opportunities for professionals interested in this niche therapeutic area. The article highlights four firms that ar…
    BioSpace · 15d agoPositive↗ source
  • ArriVent BioPharma's Phase 3 lung cancer trial misses primary endpoint, shares tumble
    ArriVent BioPharma reported that its investigational EGFR tyrosine kinase inhibitor firmonertinib did not achieve a statistically significant improvement in progression-free survival in the Phase 3…
    BioSpace · 15d agoNegative readoutNegative↗ 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 · 16d agoNegative readoutNegative↗ source
  • ArriVent shares tumble as lung cancer trial of furmonertinib misses primary goal
    ArriVent BioPharma reported that its late-stage study of furmonertinib in patients with EGFR exon 20 insertion-mutated non-small cell lung cancer did not achieve its primary endpoint. The trial, w…
    BioPharma Dive · 16d 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 · 16d agoNegative readoutNegative↗ source
  • AstraZeneca launches $1 billion R&D hub in Boston’s Kendall Square
    AstraZeneca opened a new research and development site in Kendall Square, Boston, marking a $1 billion investment in the U.S. biotech corridor. The Boston location underscores the company’s commit…
    STAT · 16d agoNeutral↗ 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 · 16d agoNegative readoutNegative↗ source
  • Experts warn FDA against approving Grail’s ineffective multicancer blood test
    Physician and cancer‑screening researcher H. Gilbert Welch argues that the FDA should not greenlight Grail’s multicancer blood test, noting the company’s trial of 140,000 participants used a weak s…
    STAT · 17d agoRegulatoryNegative↗ 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 · 17d 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 · 17d agoPositive↗ source
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 16d agoNeutral↗ source
  • Infectious disease expert urges calm over mysterious pneumonia case in Siberia
    A 28‑year‑old laboratory worker at a Siberian institute that studies plague died after developing severe pneumonia, prompting a quarantine of a nearby hospital and monitoring of roughly 200 contact…
    STAT · 16d agoNeutral↗ 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 · 18d agoApprovalPositive↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 17d agoDealPositive↗ 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 · 18d agoPositive readoutPositive↗ source
  • Roivant Sciences launches first solo drug, Lisraya, after FDA approval for dermatomyositis
    Roivant Sciences, which operates a hub-and-spoke subsidiary model, is stepping into the commercial arena with its inaugural solo product launch. The FDA has granted approval to the oral TYK2/JAK i…
    BioSpace · 18d agoApprovalPositive↗ source
  • CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
    CSL will co-develop and co-promote Alentis Therapeutics' anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune diseas…
    BioSpace · 17d agoDealNeutral↗ source
  • Diagnostic-driven therapies face patient loss due to workflow gaps, new commercialization model proposed
    The sponsored article from Diaceutics highlights that while diagnostic-driven therapies are being developed faster than ever, many patients who could benefit never receive them. The authors attribu…
    BioPharma Dive · 18d agoNeutral↗ source
  • Kodiak Sciences' Zenkuda shows non-inferior six-month dosing vs Eylea, shares double
    Four years ago Kodiak Sciences saw its share price plunge about 80% after its lead eye-disease candidate failed a head-to-head trial against Regeneron's Eylea, wiping out roughly $2 billion in mark…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source
  • BMO sees Merck better positioned than BMS to handle looming patent cliffs
    BMO Capital Markets says Merck has a stronger plan than Bristol Myers Squibb to replace revenue lost to upcoming patent expirations. The firm highlights Merck's pipeline as more derisked and sizabl…
    BioSpace · 20d agoNeutral↗ source
  • Varda Space Industries secures $251 million to produce drugs in microgravity
    Varda Space Industries, a startup partnered with United Therapeutics, announced a $251 million Series D financing round. The funding, led by Lux Capital and Natural Capital, brings total capital r…
    BioSpace · 20d agoDealPositive↗ source