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1,341 stories matching this filter · ← front page

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  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 22d agoApprovalPositive↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 23d agoPositive readoutPositive↗ source
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  • Merck, Daiichi end plans to seek speedy approval of lung cancer ADC
    The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.
    BioPharma Dive · 23d agoApprovalPositive↗ source
  • Adicet's off-the-shelf CAR-T shows 50% kidney response in early lupus trial
    An early-stage study of Adicet Bio's off-the-shelf gamma-delta CAR-T cell therapy reported encouraging results in patients with lupus nephritis. After a year of follow-up, half of the evaluable pa…
    BioPharma Dive · 23d agoPositive readoutPositive↗ source
  • Scynexis secures $214 million BARDA contract to advance oral and IV antifungal SCY-247
    BARDA awarded Scynexis a $214 million contract to develop a treatment for invasive fungal infections, including an upfront payment of about $18.5 million. The funding will support moving SCY-247,…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Tolerance Bio signs up to $560M deal for anti-IL-33 drug from Tanabe
    Tolerance Bio has licensed the rights to an anti‑IL‑33 monoclonal antibody from Mitsubishi Tanabe Pharma for use outside Japan. The antibody, previously known as MT‑2990 and to be renamed TLB‑33, w…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Precision Neuroscience raises $250M in Series D to expand brain-computer interface program
    Precision Neurosciences announced a $250 million Series D financing round that was oversubscribed. The capital injection follows previous rounds that have brought the company’s total funding to $43…
    Fierce Biotech · 23d agoDealPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 22d agoRegulatoryNeutral↗ source
  • Genentech CEO Ashley Magargee reflects on biotech origins and future amid growing startup ecosystem
    Genentech’s founder story was revisited in a recent interview with CEO Ashley Magargee. She recalled how co‑founder Herbert Boyer was initially skeptical of a brief meeting with venture capitalist…
    Fierce Biotech · 23d agoPositive↗ source
  • ai3Bio raises $48 million to develop T-cell targeting therapy for autoimmune disease
    ai3Bio announced its emergence from stealth mode after securing $48 million in Series A funding. The round was led by UPMC Enterprises and Ziff Capital Partners and combines technology from Corner…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Roche halts obesity antibody emugrobart after negative phase 2 interim readout
    Roche has stopped development of its obesity antibody emugrobart after an interim analysis of a phase 2 trial indicated a low chance of meeting the study endpoints. The antibody, designed to block…
    Fierce Biotech · 23d agoNegative readoutNegative↗ source
  • Mirum's Phase 3 Trial Shows Brelovitug Achieves Primary Endpoint in Hepatitis D Study
    Mirum Pharmaceuticals reported that its phase 3 Azure-1 trial in chronic hepatitis delta met its primary efficacy goal, marking a significant step toward market entry in a field dominated by Gilead…
    Fierce Biotech · 23d agoPositive readoutPositive↗ source
  • Kodiak Sciences' eye disease drug matches Eylea in Phase 3, sending stock soaring
    Kodiak Sciences reported that two of its eye‑disease candidates performed on par with aflibercept (Eylea) in a pivotal Phase 3 trial. The data suggest comparable efficacy in treating the targeted r…
    Fierce Biotech · 23d agoPositive readoutPositive↗ source
  • Merck signs $400 million deal with China’s SciBrunch for KRAS G12D preclinical candidate
    Merck & Co. announced a new partnership with Chinese biotech SciBrunch. The agreement includes a $400 million payment for a preclinical candidate that targets the KRAS G12D mutation. The KRAS G12D…
    Fierce Biotech · 23d agoDealNeutral↗ source
  • Sofinnova Partners raises €82 million to expand medtech creation strategy in Europe and U.S.
    Sofinnova Partners announced that it has secured €82 million ($93.3 million) in an oversubscribed financing round. The capital will be used to broaden the firm’s medtech creation strategy across Eu…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficient
    Merck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer. The FDA indicated that…
    Fierce Biotech · 23d agoRegulatoryNegative↗ source
  • Operational talent, not just science, will drive next biopharma breakthroughs
    The piece points out that while breakthrough science, founders and venture funding are typical markers of progress, the real test is moving a promising therapy through GMP production, quality syste…
    BioPharma Dive · 23d agoNeutral↗ source
  • Azurity urges simpler medicines for children to reduce daily burdens on families
    Azurity Pharmaceuticals published a sponsored article that looks at how chronic medicines can shape a child's daily routine. The piece points out that while clinical trials test drugs under strict…
    BioPharma Dive · 23d agoPositive↗ source
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 26d agoPositive readoutPositive↗ source
  • Novo’s stock tumbles after two-year GLP-1 boom as AI drug-discovery startups land huge funding rounds
    Novo’s shares, which peaked above $140 in June 2024 during a surge in demand for its GLP-1 drugs Ozempic and Wegovy, have fallen sharply over the past two years. The decline reflects a broader mark…
    BioPharma Dive · 26d agoNegative↗ source
  • Novo signs $1.3 billion deal with Nanexa to add long-acting injectables for obesity and diabetes
    Novo has entered a licensing agreement with Nanexa, valued at about 1.17 billion euros, to use Nanexa’s PharmaShell platform for its obesity and type‑2 diabetes medicines. The PharmaShell technolo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Genentech signs $1.5 billion bispecific antibody deal with Earendil Labs
    Genentech, Roche's US subsidiary, announced a licensing agreement with Earendil Labs to discover and develop multiple bispecific antibodies aimed at oncology. The agreement provides a $55 million…
    Fierce Biotech · 26d agoDealPositive↗ source
  • RNAi biotech ADARx raises $446 million in IPO, secures $89 million from AbbVie
    ADARx Pharmaceuticals priced its initial public offering at $17 per share, selling more than 26 million shares to raise about $446.3 million. The company also received an additional $89 million th…
    BioPharma Dive · 26d agoDealPositive↗ source
  • Novo signs €1.2 bn deal with Nanexa for long-acting injectables as Acadia’s Alzheimer trial misses target
    Novo has agreed to pay Nanexa up to about €1.165 bn for its PharmaShell delivery platform, which enables long-acting injectable medicines. The partnership will apply the technology to up to five c…
    BioPharma Dive · 26d agoDealNeutral↗ source
  • ADARx upsizes Nasdaq IPO to $446M as City Therapeutics eyes public listing
    ADARx Pharmaceuticals, a San Diego-based RNA biotech, completed a Nasdaq initial public offering this morning, selling 26.3 million shares at $17 each. The offering generated gross proceeds of abo…
    Fierce Biotech · 26d agoDealPositive↗ source