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1,487 stories matching this filter · ← front page

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  • Enanta cuts 37 jobs as it pivots toward immunology and awaits key antiviral trial readouts
    Enanta Pharmaceuticals announced it is laying off 37 employees as it refocuses resources ahead of upcoming trial readouts. The company said the decision was part of a fiscal year‑end review to rig…
    Fierce Biotech · 22d agoLayoffsNegative↗ source
  • Biotech firms must align operating models with their unique DNA, not rely on generic SMID templates
    The article points out that two biotech firms with similar head counts, pipelines and growth plans can operate very differently. One may build extensive internal development infrastructure, while t…
    Fierce Biotech · 22d agoNeutral↗ source
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  • UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
    The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2…
    BioSpace · 22d ago↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 23d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 23d agoDealPositive↗ source
  • Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC
    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not…
    BioSpace · 23d agoRegulatoryNegative↗ 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
  • Ultragenyx gains FDA approval for Fayuvi, a Sanfilippo syndrome A therapy, easing impact of recent Angelman setback
    Ultragenyx announced that the FDA has approved its drug Fayuvi for treating Sanfilippo syndrome type A, a rare neurodegenerative condition affecting children. The approval marks the company's first…
    BioSpace · 23d agoApprovalPositive↗ 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
  • Biopharma chases new immunology targets as Humira and Dupixent set high bar
    Johnson & Johnson, Pfizer, Argenx and several other companies are expanding their immunology pipelines, seeking new targets and improvements to capture part of the market driven by AbbVie’s Humira…
    BioSpace · 23d agoPositive↗ 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
  • Regenerative medicine requires diagnostics and product characterization beyond stem cell basics
    Stem cell therapies are often portrayed as a single treatment, but they actually vary widely in tissue source, cell passage, viability and delivery methods. Experts say a credible regenerative app…
    BioSpace · 23d agoNeutral↗ source
  • BioSpace report examines factors driving employee engagement in life sciences firms
    BioSpace released a new report titled "What Powers Employee Engagement" that looks at what influences staff morale in the life‑science sector. The study draws on data from the 2027 Best Places to…
    BioSpace · 23d agoNeutral↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 23d agoNegative↗ source
  • Mezzetta voluntarily recalls 32-oz Golden Greek Peperoncini after pest contaminant found in jar
    G. L. Mezzetta Inc. announced a voluntary recall of its 32‑oz Golden Greek Peperoncini after a video showed a pest contaminant in a jar. The recall is limited to lot 720106 (SKU 10106328). The com…
    fda recalls · 24d agoRegulatoryNeutral↗ source