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1,193 stories matching this filter · ← front page

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  • Biopharma leader urged to prioritize own job search after team layoffs
    A biopharma executive recently had to announce a downsizing of her team, and she described feeling guilt and grief for the impact on her direct reports. She said she would wait until every person…
    BioSpace · 13d agoLayoffsNeutral↗ source
  • Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
    Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
    BioSpace · 12d ago↗ source
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Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
BioSpace · 13d ago↗ source
  • Incyte's KRAS G12D inhibitor shows 89% response rate in early pancreatic cancer trial
    In a Phase 1 study, Incyte tested its KRAS G12D inhibitor together with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma carrying the G12D mutation. The combinati…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Novartis takes $1.9B write-down after Avidity's del-desiran fails Phase 3 but reaffirms confidence in $12B acquisition
    Novartis announced a $1.9 billion partial impairment after the Phase 3 HARBOR study of del-desiran, an antibody‑oligonucleotide conjugate from its Avidity Biosciences acquisition, did not meet its…
    BioSpace · 14d agoNegative readoutNeutral↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 14d agoRegulatoryNeutral↗ source
  • Alphabet’s GV tops biotech corporate investors with $5.23 billion in deals since 2025
    Alphabet’s venture arm GV has become the largest corporate spender in biotech, investing a cumulative $5.23 billion across 20 deals since the start of 2025. The total outlay exceeds the combined v…
    BioSpace · 14d agoNeutral↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 14d agoCRLNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 14d agoRegulatoryNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 14d agoRegulatoryNeutral↗ source
  • After 2 patient deaths and cell therapy durability concerns, Artiva cuts 94% of workforce
    Artiva Biotherapeutics, which had been evaluating cell therapy AlloNK for the treatment of rheumatoid arthritis and other autoimmune diseases, is exploring strategic options that could include diss…
    BioSpace · 13d ago↗ source
  • Amgen’s Imdelltra plus AstraZeneca’s Imfinzi cuts death risk by ~60% in extensive-stage small cell lung cancer
    Amgen presented Phase 3 data at ESMO 2026 showing that its bispecific T‑cell engager Imdelltra, when added to AstraZeneca’s checkpoint inhibitor Imfinzi, significantly reduced mortality in extensiv…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Genmab’s Rina-S ADC cuts risk of progression and death in Phase 3 ovarian cancer trial
    Genmab reported results from its Phase 3 RAINFOL-02 trial of the FRα‑directed antibody‑drug conjugate Rina‑S (rinatabart sesutecan) in patients with platinum‑resistant ovarian cancer. In the inten…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Biotech IPOs Pull in $7.5B Across 22 Deals in 2026, While Market Gains Stall in Q3
    Biopharma companies raised about $7.5 billion from 22 initial public offerings in the first three quarters of 2026, according to J.P. Morgan data. This level of financing far exceeds the eight offe…
    BioSpace · 15d agoDealNeutral↗ source
  • Merck and Moderna's mRNA melanoma vaccine shows 42% risk reduction in Phase 3 trial, easing analyst concerns
    At the European Society of Medical Oncology meeting, Merck and Moderna presented data from their Phase 3 INTerpath-001 trial of a personalized mRNA vaccine combined with Keytruda in resected melano…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Taysha and Neurogene close in on first Rett syndrome gene therapy as 2027 readouts loom
    Two companies, Taysha Gene Therapies and Neurogene, are nearing the final stage of development for gene therapies targeting Rett syndrome, a rare neurodevelopmental disorder with limited treatment…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • U.S. biotechs capture 68% of global VC funding since 2025, led by Bay Area and Boston
    Since the start of 2025, U.S. biopharma firms have secured $37.2 billion in venture capital, representing about 68 % of the $54.5 billion raised worldwide. The San Francisco Bay Area and Boston do…
    BioSpace · 14d agoDealNeutral↗ source
  • J&J's Halda-derived prostate cancer drug shows 75% response in early Phase 1 trial
    Johnson & Johnson's recent $3 billion purchase of Halda Therapeutics added an oral prostate cancer candidate, JNJ-6143, to its pipeline. The drug targets a cancer-specific protein to trigger cell d…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Australian clinical trials attract more U.S. sponsors amid regulatory uncertainty
    CROs are reporting faster startup timelines, predictable regulation, and tax incentives as reasons for increasing interest in conducting clinical trials in Australia. State-level incentives in Que…
    BioSpace · 15d agoNeutral↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 15d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 15d agoApprovalNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 15d agoRegulatoryNeutral↗ source
  • ESMO 2026: Merck’s Kelun-partnered ADC cuts death risk by over 30% in endometrial cancer
    Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first…
    BioSpace · 14d ago↗ source
  • Roche warns Germany faces last chance to regain pharma investment confidence
    Roche has said that recent German healthcare reforms threaten the country's attractiveness for pharmaceutical investment. The company paused its own German investment plans after the reforms were a…
    BioSpace · 17d agoRegulatoryNegative↗ source
  • Marengo's bispecific antibody invikafusp alfa shows tumor shrinkage in 8 cancer types in Phase 2
    Marengo Therapeutics presented Phase 2 data for its bispecific antibody invikafusp alfa at the European Society for Medical Oncology meeting in Madrid. The study, part of the Start-001 first‑in‑hum…
    BioSpace · 18d agoPositive readoutPositive↗ source