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151 stories matching this filter · ← front page

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  • ‘We have what we need to grow:’ Biogen CEO happy to ease off the M&A for a while
    Biogen's business development team may have been busy in recent years, but CEO Christopher Viehbacher is easing off the acquisitions for a while.
    Fierce Biotech · 5h ago↗ source
  • Novo Nordisk fails to dismiss lawsuit over CagriSema readout
    Novo Nordisk’s attempt to dismiss a lawsuit about its CagriSema readout has failed, with the judge ruling that parts of the investors’ argument were strong enough for the case to proceed.
    Fierce Biotech · 5h ago↗ source
  • Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ Rhapsido
    Processa Pharmaceuticals has made a push into the autoimmune space via the acquisition of Vidya Therapeutics, which delivers a potential rival to Novartis’ Rhapsido.
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Fierce Biotech · 5h ago
↗ source
  • ‘Reverse mergers are increasingly popular’: Caldera hops on Synlogic’s Nasdaq listing
    Caldera Therapeutics has struck a reverse merger with the publicly traded Synlogic and inked a $278 million financing deal, continuing the meteoric rise of the inflammatory bowel disease startup.
    Fierce Biotech · 7h ago↗ source
  • Vertex’s latest autoimmune TCE play involves $28M upfront to AbCellera
    AbCellera’s T-cell engager platform has reeled in a second client this summer, with Vertex paying $28 million upfront for a collaboration that will include autoimmune conditions.
    Fierce Biotech · 8h ago↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 1d agoRegulatoryNeutral↗ source
  • Eli Lilly tops new biopharma ranking on launch success, development speed
    Flush with GLP-1 cash and pipeline success, Eli Lilly rose from 16th to first over five years in Norstella’s inaugural Pipeline-to-Patient Productivity Index, which evaluated 25 large, global bioph…
    Fierce Biotech · 1d agoNeutral↗ source
  • Incyte ditches phase 1-stage JAK inhibitor to pursue next-gen options
    Incyte has ditched a JAK2 inhibitor in phase 1 development for a rare blood cancer in favor of “next-generation” replacements.
    Fierce Biotech · 1d agoNeutral↗ source
  • Altimmune’s next-gen GLP-1 curbs heavy drinking in ‘unequivocal’ ph. 2 alcohol use disorder win
    An experimental drug targeting both GLP-1 and glucagon receptors has curbed heavy drinking in a phase 2 trial, providing hope that the ubiquitous weight loss meds can be effectively harnessed again…
    Fierce Biotech · 1d agoNeutral↗ source
  • GSK unveils 3-year cost-saving plan to fund late-stage R&D, move research HQ to AZ's backyard
    GSK has unveiled an ambitious three-year plan to divert resources to its late-stage R&D programs and shift its research headquarters—but CEO Luke Miels is being tight-lipped about the extent of any…
    Fierce Biotech · 1d agoNeutral↗ source
  • Atea’s hepatitis C asset matches Gilead’s Epclusa in phase 3 trial
    Atea Pharmaceuticals’ hepatitis C prospect has matched Gilead’s Epclusa in a phase 3 trial, keeping the biotech barreling toward a second readout for its shorter, simpler treatment regimen.
    Fierce Biotech · 1d agoNeutral↗ source
  • Acrosian debuts as AI-focused biometrics CRO
    The founders of contract research organization Quartesian have reunited to form Acrosian, a CRO designed to be purpose-built for the AI era.
    Fierce Biotech · 1d agoNeutral↗ source
  • Guardant Health taps Patrick Dempsey for emotional colorectal cancer awareness video
    Colorectal cancer blood test maker Guardant Health has teamed up with “Grey’s Anatomy” star Patrick Dempsey for a new, highly emotional video.
    Fierce Biotech · 1d agoNeutral↗ source
  • GSK partner Hansoh reports another phase 3 win for priority ADC
    Hansoh Pharmaceutical has guided its GSK-partnered, B7-H3-directed antibody-drug conjugate to another phase 3 win in China.
    Fierce Biotech · 1d agoNeutral↗ 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 · 2d 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 · 2d 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 · 2d 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 · 2d agoNegative readoutNegative↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 2d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 2d agoRegulatoryNeutral↗ source
  • RA Capital launches rare disease company Oak Hill Bio onto Nasdaq via SPAC
    Rare disease biotech Oak Hill is headed to the Nasdaq through a SPAC merger with RA Capital-sponsored Research Alliance Corporation III (RACC) to fund a rare genetic disease candidate.
    Fierce Biotech · 2d agoDealNeutral↗ source