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208 stories matching this filter · ← front page

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  • Merck KGaA to acquire Silence Therapeutics for $1.1 billion, gaining Phase 3 PV siRNA asset
    Merck KGaA announced it will buy Silence Therapeutics for about $1.1 billion, giving the German group a foothold in hematology. Silence, a UK-based RNA specialist, develops short interfering RNA m…
    BioSpace · 13h agoDealPositive↗ source
  • Merck KGaA buys Silence in $1.3B deal after siRNA drug's phase 2 blood cancer win
    Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo.
    Fierce Biotech · 19h agoDealNeutral↗ source
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Nephrology627
  • Novartis halts Phase 2 lupus nephritis trial of Fabhalta, cites strategic reasons
    Novartis has stopped a Phase 2 study of its complement blocker Fabhalta (iptacopan) in patients with lupus nephritis, a kidney involving form of the disease. The company said the decision was base…
    BioSpace · 15h agoNeutral↗ source
  • Induced pluripotent stem cells gain momentum as new methods and clinical successes drive drug development
    Induced pluripotent stem cells (iPSCs) are moving from a research curiosity to a practical tool in drug development. After years of steady progress, recent advances are bringing iPSCs into the spot…
    BioSpace · 3d agoPositive↗ source
  • Labcorp teams with Thrive Global to launch Thrive 5 home health test
    Labcorp has introduced the Thrive 5 Health Test in partnership with Arianna Huffington's company, Thrive Global. The test is sold through Labcorp's OnDemand home testing service and pairs laborato…
    Fierce Biotech · 4d agoPositive↗ source
  • FDA issues early alert for Edwards Lifesciences’ mitral valve delivery system after reported death, injury
    The FDA has issued an early alert for certain delivery systems used with Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system amid serious safety concerns.
    Fierce Biotech · 4d ago↗ source
  • AstraZeneca teams with insitro in up to $1.5 billion AI partnership to target MASH and cardiomyopathies
    AstraZeneca announced a partnership with AI-driven biotech insitro, committing up to $1.5 billion to discover new drug targets for metabolic dysfunction-associated steatohepatitis (MASH) and cardio…
    BioSpace · 4d agoDealPositive↗ source
  • AstraZeneca signs $1.5B AI partnership with insitro to discover liver and heart disease targets
    AstraZeneca announced a partnership with insitro, a biotech that uses artificial intelligence, with an upfront payment of $40 million and potential milestones up to $1.46 billion. The collaboratio…
    Fierce Biotech · 5d 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
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4d agoLayoffsNegative↗ source
  • Alnylam shares tumble to $250 after cutting full-year revenue guidance for its TTR franchise
    Alnylam Pharmaceuticals saw its share price slide to about $250 after the company lowered its full-year revenue outlook for its transthyretin (TTR) franchise. The guidance cut, announced in July, f…
    BioSpace · 5d agoEarningsNegative↗ source
  • TRexBio and Retension raise $161.7M in IPOs as biotech fundraising surge continues
    TRexBio and Retension Pharmaceuticals are slated to begin trading on Friday, together raising $161.7 million. Their offerings push the number of biotech IPOs this year to 29, underscoring a continu…
    BioSpace · 10d agoDealPositive↗ source
  • Newron reports five deaths in schizophrenia trial as FDA keeps hold on evenamide study
    Newron Pharmaceuticals disclosed that five participants have died in its late-stage schizophrenia trial, with four deaths among those receiving the investigational drug evenamide and one death amon…
    BioSpace · 11d agoRegulatoryNegative↗ source
  • Zealand Pharma’s petrelintide shows 9% weight loss in Phase 2 but fails to improve blood sugar, analysts unimpressed
    Zealand Pharma, in partnership with Roche, reported results from the Phase 2 ZUPREME-2 trial of petrelintide, a long‑acting human amylin analog, in 220 obese or overweight patients with type 2 diab…
    BioSpace · 11d agoNegative readoutNeutral↗ source
  • Venture debt becomes central financing option for late-stage European biotech
    BioSpace’s Denatured podcast recently featured Jennifer McMahon of Seroba and Joey Mason of Claret Capital discussing the growing role of venture debt in European biotech. The guests explained tha…
    BioSpace · 11d agoPositive↗ source
  • Zealand's amylin analog shows strong weight loss but weak blood-sugar control in phase 2 trial
    Zealand Pharma, in partnership with Roche, released topline results from its mid‑phase Zupreme‑2 study of petrelintide, an amylin‑based candidate aimed at patients with overweight or obesity and ty…
    Fierce Biotech · 12d agoNegative readoutNegative↗ 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 · 12d agoPositive↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 12d agoDealNegative↗ source
  • Bayer invests $2.2 billion in Ohio to build pharma manufacturing plant
    Bayer announced a $2.2 billion investment to construct a new pharmaceutical manufacturing complex in New Albany, Ohio. The plant will produce drug substances and finished products for oncology, ca…
    BioSpace · 12d agoDealNeutral↗ 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 · 13d 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
  • Viking Therapeutics jumps 24% after Phase 1 obesity data, Longeveron falls 64% on mid-stage setback
    In September biotech stocks showed wide swings, with Viking Therapeutics gaining 24% and Longeveron dropping 64% as investors reacted to clinical data and trial setbacks. Viking reported Phase 1 r…
    BioSpace · 14d agoPositive readoutNeutral↗ 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 · 15d agoApprovalPositive↗ source
  • Regeneron explores pairing its obesity drug with lipid-lowering therapy to differentiate in crowded GLP-1 market
    The pipeline of GLP-1 based medicines is delivering increasingly strong weight-loss results, prompting many companies to seek ways to stand out as the market fills. Regeneron said it is looking at…
    Endpoints · 17d agoPositive↗ source