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1,098 stories matching this filter · ← front page

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  • FDA advisory panel debates allowing compounding pharmacies to produce seven peptides
    The FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • Webinar Explores AI-Driven Intelligence Engine for Optimizing Antibody, ADC and Peptide Candidates
    Drug discovery teams are grappling with an ever‑growing volume of data, and converting that data into actionable insight remains a key hurdle. In a recent BioSpace webinar, Patsnap’s Ben Coverdale…
    BioSpace · 4d agoNeutral↗ source
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  • Incyte drops phase-1 JAK2 inhibitor to focus on next-generation candidates
    Incyte announced it is abandoning its phase-1 JAK2V617F inhibitor, INCB160058, which was being tested in patients with myeloproliferative neoplasms. The decision was disclosed in the company's sec…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Acrosian launches AI-focused biometrics CRO targeting pharma and biotech
    Acrosian has been introduced as a new contract research organization built for the AI era. The firm is founded by Benjamin Jackson, Soumitra Chowdhury and Vladimir Mats, who previously created the…
    Fierce Biotech · 4d agoPositive↗ source
  • Guardant Health partners with Patrick Dempsey for emotional colorectal cancer screening video
    Guardant Health, maker of the Shield blood test for colorectal cancer, released a new video featuring actor Patrick Dempsey to raise awareness of the disease. In the one‑minute clip, Dempsey watch…
    Fierce Biotech · 4d agoPositive↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 5d agoDealPositive↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 5d agoApprovalPositive↗ source
  • FDA approves Freenome colorectal cancer blood test to be marketed by Abbott
    The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S.
    Fierce Biotech · 5d agoApprovalPositive↗ source
  • InnoCare’s oral TYK2 inhibitor clears phase 3 psoriasis test
    InnoCare Pharma announced Monday that its oral tyrosine kinase 2 (TYK2) inhibitor fadeucravacitinib met the primary endpoint in a phase 3 trial of adults with moderate-to-severe plaque psoriasis.
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • After missed endpoint, Gossamer and Chiesi pull the plug on PAH drug collaboration
    After signing a deal worth up to $486 million with Italian biopharma Chiesi to develop its pulmonary arterial hypertension (PAH) candidate seralutinib in 2024, Gossamer Bio has ended the collaborat…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • AstraZeneca execs ‘very confident’ in homegrown ADC pipeline despite scrapping 2 candidates
    AstraZeneca executives told Fierce they are “very confident” in the pharma’s in-house pipeline of ADCs despite scrapping two candidates that underperformed in the clinic.
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Claris Biotherapeutics raises $118M Series B to advance corneal stem-cell eye drop
    Claris Biotherapeutics announced a $118 million Series B financing round led by Novo Holdings and supported by several venture firms. The funding will be used to move its lead candidate, CSB-001, i…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Yarrow goes public while Otsuka receives FDA approval for new ADHD medication
    Yarrow Bioscience completed a merger that took the company public and will now trade under its own ticker. The firm is developing an anti-TSHR antibody aimed at treating Graves’ disease and the ass…
    Endpoints · 5d agoApprovalPositive↗ source
  • RA Capital backs Oak Hill Bio's Nasdaq debut via $175 million SPAC merger
    RA Capital announced that its SPAC, Research Alliance Corporation III, will merge with Oak Hill Bio, creating a new Nasdaq-listed rare-disease company. The combined entity will start with $175 mil…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Virginia judge orders FDA to revisit Biden-era mifepristone restrictions
    A federal judge in Virginia has ruled that the FDA must reexamine certain restrictions on the abortion medication mifepristone that were put in place during the previous administration. The judge…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Fujifilm Biotech CEO warns CDMOs must expand services ahead of looming patent cliff
    Fujifilm Biotechnologies CEO Lars Petersen said drugmakers are gearing up for a looming biopharma patent cliff in 2026, a situation that could pressure revenue streams as key patents expire. He wa…
    Endpoints · 5d agoNeutral↗ source
  • FDA questions efficacy of Capricor's Duchenne muscular dystrophy cell therapy ahead of advisory committee
    FDA reviewers have raised concerns about the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy as the agency prepares for an advisory committee meeting. The agency said it could n…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 5d agoPositive readoutNegative↗ source
  • FDA says Capricor's DMD cell therapy failed to meet Phase 3 endpoints
    The FDA briefing documents released before an advisory committee meeting state that the Phase 3 trial of Capricor's deramiocel did not achieve its pre-specified primary and secondary efficacy endpo…
    BioSpace · 5d agoRegulatoryNegative↗ source
  • MapLight's schizophrenia drug fails primary endpoint in Phase 2, sending stock down over 60%
    MapLight Therapeutics saw its shares tumble more than 60% after a mid‑stage trial showed that its once‑daily schizophrenia candidate did not meet the primary efficacy endpoint, even though the over…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 5d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie R&D chief Michael Severino as new CEO amid DMD regulatory outlook
    Sarepta Therapeutics announced that Michael Severino, who previously led Tessera Therapeutics and served as AbbVie’s head of research and development, will become the company’s chief executive. Sev…
    BioSpace · 5d agoPositive↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 5d agoNeutral↗ source
  • Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom
    Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…
    BioSpace · 5d agoNeutral↗ source
  • Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval
    Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…
    BioSpace · 5d agoPositive readoutPositive↗ source