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  • 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 · 21d agoPositive readoutPositive↗ 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    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan.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 · 21d agoRegulatoryNegative↗ source
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  • 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 · 21d agoPositive↗ 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 · 21d agoNegative↗ source
  • Merck's Welireg receives FDA nod for expanded use with Lenvima in kidney cancer
    Merck announced that its drug Welireg has received FDA approval for use together with Eisai's Lenvima in patients with advanced renal cell carcinoma. The clearance broadens the indication, allowin…
    Endpoints · 24d agoApprovalPositive↗ 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 · 24d agoPositive readoutPositive↗ source
  • Genentech signs $55M upfront deal with AI firm Earendil Labs to develop bispecific cancer antibodies, potential total value over $1.5B
    Genentech announced a partnership with AI‑driven Earendil Labs that includes a $55 million upfront payment and could exceed $1.5 billion when development, regulatory and sales milestones are met. T…
    BioSpace · 24d 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 · 25d 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 · 24d 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 · 24d agoDealPositive↗ source
  • NIH deputy director Nicole Kleinstreuer leads push to cut animal testing with new policies
    NIH has spent the past 18 months accelerating policies aimed at reducing the use of animals in research. The effort is being directed by Dr. Nicole Kleinstreuer, the agency’s deputy director for p…
    Fierce Biotech · 24d agoRegulatoryPositive↗ source
  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 25d agoDealPositive↗ source
  • Roche signs $2 billion deal with Atavistik to discover allosteric cardiovascular-renal-metabolic drugs
    Roche announced a partnership with Cambridge-based biotech Atavistik Bio to develop allosteric small-molecule therapies for cardiovascular, renal and metabolic diseases. The agreement includes an u…
    Fierce Biotech · 25d agoDealPositive↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 25d agoDealNeutral↗ source
  • Travere appoints former Amicus CEO Bradley Campbell as new chief executive
    Travere Therapeutics CEO Eric Dube is stepping down after overseeing the launch of the rare kidney disease drug Filspari. Bradley Campbell will assume the role on Dec 1, bringing experience from l…
    Fierce Biotech · 25d agoNeutral↗ source
  • Roche and Ionis report Phase 3 success for RNA therapy sefaxersen in IgA nephropathy
    A late‑stage Phase 3 trial of the Roche‑Ionis RNA‑targeted drug sefaxersen met its primary endpoint, showing a statistically significant reduction in proteinuria for patients with primary IgA nephr…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Ionis and Otsuka's RNA therapy Ulefnersen shows functional and survival gains in rare FUS-ALS in Phase 3 trial
    Ionis Pharmaceuticals and Otsuka Pharmaceutical reported that their antisense oligonucleotide drug Ulefnersen improved both functional impairment scores and overall survival in a Phase 3 study of p…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Roche reports phase 3 success for sefaxersen in IgA nephropathy, eyes accelerated approval
    Roche announced that its experimental drug sefaxersen met the primary endpoint in a phase 3 trial for IgA nephropathy, showing reduced proteinuria versus placebo. The interim analysis at week 37 d…
    Fierce Biotech · 26d agoPositive readoutPositive↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 26d agoPositive readoutPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 26d agoPositive readoutPositive↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 26d agoRegulatoryNegative↗ source
  • Four biotech firms file for IPOs as 2026 biotech listing surge continues
    2026 has seen more than 25 biotech companies debut on public markets, marking the highest number of IPOs since 2021. The wave of listings has helped the sector recover from a slowdown in 2025. Fou…
    BioSpace · 27d agoDealPositive↗ source
  • Vertex reports positive Phase 2b results for inaxaplin in APOL1-mediated kidney disease
    Vertex Pharmaceuticals announced positive Phase 2b data for its kidney disease candidate inaxaplin, which targets APOL1-mediated kidney disease (AMKD). The Amplified trial enrolled two cohorts: 2…
    Fierce Biotech · 27d agoPositive readoutPositive↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 27d agoPositive readoutPositive↗ source
  • John Gaitanis appointed chair of federal autism committee amid disclosed leucovorin ties
    The Interagency Autism Coordinating Committee (IACC) has named pediatric neurologist John Gaitanis as its new chair. Gaitanis, who has spent his career treating children with neurological disorder…
    STAT · 27d agoNegative↗ source