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  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1h agoDealPositive↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1h agoDealNeutral↗ source
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  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    BioPharma Dive · 2h agoEarningsNeutral↗ source
  • FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data
    Replimune shares plummeted 40% on concerns FDA scientists are still skeptical of its melanoma drug. Elsewhere, investors had a muted reaction to a first-of-its-kind study result.
    BioPharma Dive · 2h ago↗ source
  • ‘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 · 6h 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 · 7h 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.
    Fierce Biotech · 7h 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 · 8h 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 · 9h ago↗ source
  • GSK prepares for patent cliff with $2.5B cost-cutting plan
    The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss of patents important to its HIV drug franchise.
    BioPharma Dive · 1d agoLayoffsNegative↗ 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
  • An eye drug biotech banks $118M and stocks its executive suite
    Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • The FDA was all in on AI. Will that change?
    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.
    BioPharma Dive · 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 scientists question Capricor data; Legend CEO steps down
    Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation extended a stock slide for Legend and AstraZeneca disclosed more pipe…
    BioPharma Dive · 2d 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 · 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