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  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
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  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genom…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Foods Alive recalls organic moringa leaf powder over possible Salmonella contamination
    Foods Alive Inc. of Angola, Indiana announced a recall of its 8‑ounce organic moringa leaf powder because of a potential Salmonella contamination. The product was shipped nationwide between Jan 27…
    fda recalls · 2mo agoCRLNeutral↗ source
  • AbbVie’s bispecific T‑cell engager etentamig shows positive phase 3 results in relapsed/refractory multiple myeloma
    AbbVie reported that its bispecific T‑cell engager etentamig met its primary goals in the phase 3 Cervino trial for patients with relapsed or refractory multiple myeloma. The trial demonstrated hi…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Pfizer sells Seagen-derived ADC to Medicus Pharma for $12 million upfront, potential $1 billion milestones
    Pfizer has transferred rights to an antibody‑drug conjugate it acquired in its Seagen purchase to Medicus Pharma. Medicus will pay $12 million upfront and $15 million a year later, and Pfizer coul…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Ultragenyx's Angelman gene therapy fails Phase 3, company to cut expenses
    Ultragenyx reported that its late‑stage Aspire trial of apazunersen in Angelman syndrome did not meet its primary or secondary endpoints. The primary goal of improving the Bayley‑4 cognitive raw sc…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • CBER official overturns Replimune melanoma drug rejection; AbbVie reports phase 3 success in multiple myeloma
    A CBER regulator has reversed a prior decision to reject Replimune's experimental melanoma therapy, allowing the program to move forward. AbbVie announced that its multiple myeloma candidate achie…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…
    raps · 2mo agoRegulatoryNeutral↗ source
  • American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
    FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) mult…
    fda recalls · 2mo agoRegulatoryNeutral↗ source
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Fi recalls dog supplements over possible Salmonella contamination
    Fi, a New York-based company, announced a recall of its dog supplement products due to potential Salmonella contamination linked to an ingredient supplied to its manufacturer. The manufacturer has…
    fda recalls · 2mo agoCRLNegative↗ source
  • SUPPLX.com recalls two male sexual-enhancement supplements after FDA finds undeclared yohimbine
    SUPPLX.com announced a voluntary recall of its Business Pill and Branch Manager for Men supplements after FDA laboratory analysis detected undeclared yohimbine in both products. Yohimbine is a pre…
    fda recalls · 2mo agoCRLNegative↗ source
  • Psilocybin prevents chemotherapy-induced neuropathy in mouse study, effects last up to eight months
    Researchers at MD Anderson reported that a single dose of psilocybin given before chemotherapy blocked the development of pain hypersensitivity in mice. The protective effect persisted for up to ei…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • UK government proposes legal amendments to modernize medicines and medical device regulations
    The UK government has introduced a set of legal amendments aimed at updating the framework that governs medicines and medical devices. The changes are intended to streamline approval processes, in…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Novartis signs up to $3.2 billion deal with Korea's Alteogen for subcutaneous drug delivery technology
    Novartis has entered an option and license agreement with Korean biotech Alteogen to use its ALT-B4 subcutaneous delivery platform, a partnership that could be worth up to $3.2 billion if all optio…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • H1 partners with Novo Nordisk to build AI-driven data foundation for clinical development
    Clinical trials are becoming more complex and data‑heavy, but decision‑making processes have not kept pace. H1 and Novo Nordisk are collaborating to address this gap. Novo Nordisk’s StudyHub links…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Fortrea acquires Worldwide Clinical Trials' early-phase division for $45 million
    Fortrea announced it will purchase the early-phase services division of Worldwide Clinical Trials for $45 million. The transaction gives Fortrea control of Worldwide's clinical pharmacology unit,…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Novartis to cut about 130 jobs in Switzerland as it reshapes biologics production in Basel
    Novartis announced it will eliminate roughly 130 positions in Switzerland as part of a reorganization of its biologics technical development and manufacturing footprint in Basel. The company plans…
    Fierce Biotech · 2mo agoLayoffsNegative↗ source
  • Teva's anti-IL-15 antibody meets primary endpoint in phase 2a celiac disease trial
    Teva Pharmaceuticals reported that its anti‑interleukin‑15 antibody, TEV‑408, achieved the primary endpoint in a phase 2a study of 50 adults with celiac disease. Participants received a single dose…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • SEC and FDA sign three-year info-sharing pact to boost market integrity and public-health oversight
    The U.S. Securities and Exchange Commission and the Food and Drug Administration have entered into a three-year memorandum of understanding to expand cooperation and share information. The MOU is…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ source
  • TScan Therapeutics cuts 75% of staff to focus on preclinical solid tumor programs
    TScan Therapeutics said it will cut about three quarters of its workforce after pausing its hematological and autoimmune programs. The company will shift resources to its preclinical solid tumor p…
    Fierce Biotech · 2mo agoLayoffsNegative↗ source
  • EMA starts voluntary data-sharing pilot to boost confidence in new approach methods and cut animal testing
    The European Medicines Agency announced a voluntary data submission pilot that allows drug developers to upload data generated by new approach methodologies (NAMs). The pilot is designed to build…
    raps · 2mo agoRegulatoryPositive↗ source
  • Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
    On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
    fda recalls · 2mo agoCRLNegative↗ source