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1,222 stories matching this filter · ← front page

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  • Evommune gives up hope for MRGPRX2 antagonist to treat itch after latest phase 2 fail
    Evommune’s MRGPRX2 antagonist has flunked another phase 2 trial, wiping out the biotech’s last hopes of developing the therapy for any itch-related conditions.
    Fierce Biotech · 7h agoNegative readoutNegative↗ source
  • Biopharma looks beyond China to five alternative overseas markets amid rising geopolitical tensions
    Geopolitical tensions between the United States and China are prompting biopharma companies to look beyond the Chinese market for growth. China remains the leading destination, with licensing deal…
    BioSpace · 7h agoNeutral↗ source
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fda recalls70
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Infectious Disease444
  • Biotech crossover rounds projected to exceed $4.2 billion in 2026, supporting IPO pipeline
    PitchBook forecasts that biotech crossover rounds could surpass $4.22 billion across roughly 28 rounds in 2026. The surge follows a market bottom after COVID and a rise in investor confidence, wit…
    BioSpace · 7h agoDealPositive↗ source
  • Career setbacks offer data points, not definitive verdicts, says executive coach
    Angela Justice, an executive coach, describes how a sudden layoff can feel like a verdict but is really just a data point. She warns that people often turn the specific lesson from a setback into…
    BioSpace · 4h agoNeutral↗ source
  • Solstice rises with $225M to develop next-gen CTLA-4 drug from China
    Solstice Oncology, founded in February, is emerging from stealth having already secured an investigational new drug application from the FDA for a Phase 2 trial of a CTLA-4 antibody purchased from…
    BioSpace · 31m ago↗ source
  • A new immuno-oncology play raises $225M for a next-generation drug
    Solstice Oncology is advancing a medicine from China’s Harbour BioMed that it believes is able to address the weaknesses of drugs aimed at CTLA-4, a popular but tricky cancer immunotherapy target.
    BioPharma Dive · 32m ago↗ source
  • Caspian launches with $50M, Lilly support to advance disease-modifying diabetes bet
    Kura Oncology has spun out Caspian around KO-7246, which seeks to increase the number and activity of beta cells in the pancreas, in turn boosting insulin production in patients with diabetes.
    BioSpace · 32m ago↗ source
  • Beeline flies into phase 3 as oral lupus drug soars past placebo
    A phase 2 trial of Beeline Medicines’ afimetoran has hit its primary endpoint, positioning the biotech to swarm into pivotal development in two forms of lupus.
    Fierce Biotech · 7h ago↗ source
  • Solstice rises with $225M series A to advance next-gen CTLA-4 immunotherapy into phase 2
    Solstice Oncology has secured $225 million in series A funds to advance a next-gen immunotherapy that the biotech hopes will turn “darkness to light” for cancer care.
    Fierce Biotech · 11h ago↗ source
  • Inhibrx’s OX40 agonist plus Keytruda shows 48% response rate, beating Keytruda alone in head and neck cancer Phase 2
    Inhibrx reported results from its Phase 2 HexAgon trial evaluating INBRX-106, an OX40 receptor agonist, combined with Merck’s Keytruda in patients with treatment‑naïve, PD‑L1‑positive metastatic or…
    BioSpace · 20h agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • 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 · 23h agoNegative readoutNegative↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 1d agoCRLNegative↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 16h agoPositive readoutPositive↗ source
  • Structure Therapeutics reports oral GLP-1 weight-loss results comparable to Wegovy and strong Phase 1 amylin data
    Structure Therapeutics announced that its oral GLP-1 candidate aleniglipron achieved 72-week weight-loss results that BMO Capital Markets said were in line with Novo Nordisk’s oral Wegovy. Particip…
    BioSpace · 21h agoPositive readoutPositive↗ source
  • Novo Nordisk halts two more late-stage heart failure trials, calling IL-6 an invalid target
    Novo Nordisk said it is ending two late-stage heart-failure studies, HERMES and ATHENA, that were testing its IL-6 inhibitor ziltivekimab. The company cited a recommendation from the Data Monitorin…
    BioSpace · 21h agoNegative readoutNegative↗ source
  • Novartis' del-desiran misses primary goal in late-stage myotonic dystrophy trial
    Novartis announced that its experimental RNA drug del-desiran did not achieve the primary endpoint in a late-stage study of myotonic dystrophy type 1, a rare muscle‑weakening disease. The trial me…
    BioPharma Dive · 22h 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 · 23h agoApprovalPositive↗ source
  • 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 · 1d 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 · 1d agoDealPositive↗ source
  • Spyre Therapeutics reports positive Phase 2 results for anti-IL-23 antibody SPY003 in ulcerative colitis
    Spyre Therapeutics announced that its anti‑IL‑23 antibody, SPY003, achieved its primary and secondary goals in a Phase 2 ulcerative colitis study. The trial, part A of the Skyline program, enrolled…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • BMS CAR-T therapy arlo-cel meets primary endpoint in pivotal multiple myeloma trial
    Bristol Myers Squibb reported that its GPRC5D-directed CAR-T cell therapy, arlo-cel, achieved the primary endpoint in the pivotal Quintessential trial for multiple myeloma. The study enrolled pati…
    Fierce Biotech · 1d 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 · 1d 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 · 1d agoNeutral↗ source