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2,083 stories matching this filter · ← front page

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  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 2h agoNegative readoutNegative↗ source
  • FDA approves AstraZeneca's oral SERD Etcamah for HR+/HER2-negative advanced breast cancer
    FDA granted approval to AstraZeneca's camizestrant, marketed as Etcamah, an oral selective estrogen receptor degrader (SERD) for a specific subset of advanced breast cancer patients. The indicatio…
    BioSpace · 2h agoApprovalPositive↗ source
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fda recalls67
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Infectious Disease444
  • BrainChild Bio secures $119M Series A to advance CAR-T therapy for deadly pediatric brain tumor
    BrainChild Bio announced a $119 million Series A financing round aimed at moving its CAR‑T programs for central nervous system cancers in children forward. The company’s lead candidate, BCB-276, w…
    BioSpace · 3h agoDealPositive↗ source
  • BrainChild secures $116M to advance CAR-T therapies for rare pediatric brain tumors
    BrainChild Bio, a Seattle‑based biotech spun out of Seattle Children’s Hospital, announced it has raised $116 million in venture financing. The capital will fund the development of its CAR‑T cell t…
    BioPharma Dive · 3h agoDealPositive↗ source
  • Roivant's inhaled drug mosliciguat achieves positive Phase 2 results in interstitial lung disease
    Roivant Sciences reported that its inhaled candidate mosliciguat has successfully completed a Phase 2 trial in patients with interstitial lung disease. The study met its primary endpoint, showing a…
    Endpoints · 4h agoPositive readoutPositive↗ source
  • Moderna and Merck’s personalized mRNA cancer vaccine success spurs industry shift to faster, smaller-scale production
    After mastering large‑scale mRNA manufacturing during the COVID‑19 pandemic, the sector is now turning its attention to delivering individualized vaccines to patients quickly. The recent clinical…
    BioSpace · 10h agoPositive↗ source
  • Parkinson's drug pipeline diversifies as firms seek disease-modifying therapies
    Several pharmaceutical companies are shifting away from the traditional alpha-synuclein antibody strategy and exploring alternative mechanisms to treat Parkinson's disease. AC Immune is highlighted…
    BioSpace · 10h agoNeutral↗ source
  • Moonwalk Biosciences raises $70M to move RNAi obesity drug MW101 toward first-in-human trials in 2027
    Moonwalk Biosciences, an obesity drug developer backed by Eli Lilly, announced a $70 million Series B financing. The funding will support its lead RNAi candidate, MW101, which in mouse studies pro…
    BioSpace · 2h agoDealPositive↗ source
  • Novartis' pelacarsen fails Phase 3, casting doubt on Lp(a) lowering strategy
    Novartis announced that its antisense drug pelacarsen failed to meet the primary endpoint in the Phase 3 Lp(a)HORIZON trial. The study was intended to determine whether the drug’s ability to lower…
    BioSpace · 2h agoNegative readoutNegative↗ source
  • Inhibrx reports promising mid-stage data for OX40 agonist and plans vaccine combos early next year
    Inhibrx Biosciences announced that its OX40 agonist showed encouraging activity in a mid-stage trial involving immunogenic cancers. The data suggest the agent may also enhance responses when paire…
    Endpoints · 3h agoPositive readoutPositive↗ source
  • BrainChild Bio raises $116 million to fund pivotal pediatric brain tumor CAR-T trial
    BrainChild Bio, a Seattle-based biotech, announced it has secured $116 million in financing to support a pivotal clinical trial of its CAR-T therapy aimed at pediatric brain tumors. The funding ro…
    Endpoints · 3h agoDealPositive↗ source
  • Diabetes cell-therapy firms Sernova and Seraxis announce merger
    Two diabetes-focused cell-therapy companies, Sernova and Seraxis, have agreed to merge after decades of developing treatments for the disease. The combined company aims to pool resources and exper…
    Endpoints · 3h agoDealNeutral↗ source
  • Novartis shares tumble after late-stage failure of Avidity-acquired drug
    Novartis announced that its late-stage trial of a drug it acquired from Avidity did not meet its primary endpoints. The setback follows a recent disappointment in a heart disease study, adding pres…
    Endpoints · 6h agoNegative readoutNegative↗ source
  • Benelux’s strong science base eyed for biotech scaling despite funding gaps
    Belgium and the Netherlands have built some of Europe’s strongest life‑science ecosystems, anchored by leading research institutions and a growing pool of biotech talent. Early‑stage capital remai…
    BioSpace · 7h agoPositive↗ source
  • AI can transform drug discovery only when its strengths are properly leveraged
    The article notes a split narrative in the industry, with some headlines promising AI will speed drugs to market while others warn it could waste resources. Thomas M. Kaiser, a medicinal chemist,…
    BioSpace · 9h agoNeutral↗ source
  • Novartis' del-desiran fails primary endpoint in phase 3 Harbor trial for myotonic dystrophy type 1
    Novartis announced that its experimental therapy del-desiran did not meet the primary endpoint in the phase 3 Harbor trial, which evaluated improvement in video hand opening time in patients with m…
    Fierce Biotech · 11h agoNegative readoutNegative↗ source
  • Moonwalk Biosciences raises $70M to advance siRNA obesity therapy
    Moonwalk Biosciences announced it has secured $70 million in financing to move its obesity program into clinical testing. The funding will support development of a small interfering RNA (siRNA) th…
    Endpoints · 2h agoDealPositive↗ source
  • Beam Therapeutics reports one-year data from early-stage AATD gene therapy trial
    Beam Therapeutics released new results from its early-stage gene-editing program targeting alpha-1 antitrypsin deficiency (AATD), a rare condition that can damage the lungs and liver. The data com…
    Endpoints · 6h agoPositive readoutPositive↗ source
  • Four CDMOs to watch as biopharma outsourcing grows
    The article lists four contract development and manufacturing organizations (CDMOs) that biopharma companies can partner with as demand for external development and manufacturing rises. Lonza, bas…
    BioSpace · 10h agoNeutral↗ source
  • Consumer apps are turning to patient health records to expand services
    A few years ago patients had to remember every provider they visited and log into each portal separately to collect their full medical history. Gathering records was a fragmented and time‑consuming…
    Endpoints · 1h agoNeutral↗ source
  • Roivant's pulmonary hypertension drug shines with ‘blowout’ Phase 2 data
    Mosliciguat, being developed by the Roivant Sciences subsidiary Pulmovant, 'significantly exceeded expectations' in reducing pulmonary vascular resistance, according to analysts, and is progressing…
    BioSpace · 16m ago↗ source
  • Sandoz unveils plan for biosimilar expansion and new $300M factory in Slovenia
    LONDON — Sandoz is betting big on its newly formed biosimilar unit, as it reveals plans to grow its pipeline there by more than sevenfold and also invests $300 million in a new biosimilar manufactu…
    Endpoints · 23m ago↗ source
  • Bristol Myers claims Phase 2 success for GPRC5D-directed CAR-T
    CAR-T therapy has revolutionized blood cancer treatment, particularly in multiple myeloma. But an ongoing concern remains: If patients’ cancers progress after receiving CAR-T, what other options do…
    Endpoints · 29m ago↗ source
  • Pharvaris' latest phase 3 win builds case for HAE drug with FDA verdict pending
    Pharvaris’ deucrictibant has tasted success in a second phase 3 study, strengthening the case for the therapy to treat hereditary angioedema patients as the Swiss biotech awaits an FDA approval dec…
    Fierce Biotech · 5h ago↗ source
  • Bristol Myers’ pivotal CAR-T multiple myeloma trial hits primary endpoint
    A pivotal trial of Bristol Myers Squibb’s GPRC5D-directed CAR-T cell therapy has hit its primary endpoint, furthering the drugmaker’s efforts to challenge Johnson & Johnson for the post-BCMA multip…
    Fierce Biotech · 5h ago↗ source