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235 stories matching this filter · ← front page

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  • Argenx CEO Karen Massey drives $3.4 billion of acquisitions to expand beyond Vyvgart
    Argenx, a rare‑disease biotech, announced that under its new CEO Karen Massey it has pursued two acquisitions. The deals together have a potential value of about $3.4 billion and are intended to b…
    Endpoints · 1d agoDealPositive↗ source
  • AstraZeneca withdraws EU filing for monoclonal antibody targeting amyloidosis subset
    AstraZeneca has announced that it is pulling its European marketing application for a monoclonal antibody intended for a specific subgroup of amyloidosis patients. The decision follows earlier fail…
    Endpoints · 1d agoRegulatoryNegative↗ source
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Nephrology764
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Dual targeting of GPCRs and mutated Gαq/11 shows promise for uveal melanoma
    Researchers at Thomas Jefferson University reported a new strategy to disrupt signaling in uveal melanoma, a rare eye cancer. The study found that simultaneously inhibiting the G protein-coupled r…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Merck KGaA receives FDA approval for Abbisko-licensed joint tumor therapy
    Merck KGaA announced that the U.S. Food and Drug Administration has granted approval to a drug it licensed from Chinese biotech Abbisko. The approval covers treatment of rare non-cancerous tumors t…
    Endpoints · 3d agoApprovalPositive↗ source
  • Start Center for Cancer Research launches Italy’s first early-phase oncology trial site with IFO
    Start Center for Cancer Research has opened its first early-phase cancer clinical trial site in Italy, partnering with the public research hospital group Istituti Fisioterapici Ospitalieri (IFO).…
    Fierce Biotech · 4d agoDealPositive↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 5d agoRegulatoryNegative↗ source
  • FDA orders label warnings for GLP-1 drugs over rare eye-loss risk
    The U.S. Food and Drug Administration has issued a safety communication that requires all glucagon-like peptide-1 receptor agonist (GLP-1 RA) products to add new warnings to their labeling. The ad…
    fda medwatch · 5d agoRegulatoryNegative↗ source
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Harvard scientist George Church quits AI startup Radical, alleging partner stole his credit
    George Church, a prominent Harvard researcher known for advising biotech and synthetic biology ventures, has stepped down from his role at the artificial‑intelligence startup Radical. In a public…
    Endpoints · 8d agoNegative↗ source
  • Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys gene therapy for Duchenne muscular dystrophy
    Sarepta Therapeutics announced it will no longer enroll additional patients in the Phase 3 confirmatory study of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial was intended t…
    Endpoints · 8d agoCRLNegative↗ source
  • Onchilles reports that direct tumor injection of N17350 clears distant lesions in solid tumor models
    Onchilles, a San Diego biotech, presented data on its therapeutic elastase N17350, a vaccine‑like agent injected directly into solid tumors. In preclinical studies the intratumoral injection not o…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • AstraZeneca proposes $10 billion purchase of Rhythm Pharmaceuticals, sparking possible bidding war
    AstraZeneca has reportedly made an offer of about $10 billion to buy Rhythm Pharmaceuticals, a company focused on rare obesity disorders. Analysts from at least three research groups say the propo…
    Fierce Biotech · 9d agoDealNeutral↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 9d agoDealPositive↗ source
  • Agios to cut over 202 R&D positions as it awaits FDA decision on sickle cell drug
    Agios Pharmaceuticals said it will eliminate more than 100 research and development positions by the end of 2026, cutting its R&D workforce by roughly 35% from 2025 levels. The company entered the…
    Fierce Biotech · 9d agoLayoffsNegative↗ source
  • Servier’s $1.55 B Edgewise muscular dystrophy trial fails to meet primary and secondary endpoints
    Servier invested roughly $1.55 billion in Edgewise Therapeutics' muscular dystrophy program and, five months after the deal, announced that the pivotal phase 2 trial in Becker muscular dystrophy di…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Ultragenyx to cut 20% of staff and halve R&D budget as it pivots to commercial sales
    Ultragenyx announced it will reduce its workforce by about 20%, bringing headcount down to roughly 1,000 employees. The cuts follow an earlier 10% reduction announced in February and are part of a…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • Charles River partners with Ipsen to employ virtual control groups in toxicology studies
    Charles River Laboratories and French biopharma Ipsen announced a collaboration to use Charles River’s virtual control group (VCG) database in an upcoming toxicology study. The VCG approach aims t…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Compact Medical issues recall and updated instructions for ButterflyBVM bag-valve-mask resuscitators due to bellows holes
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk problem with certain Compact Medical ButterflyBVM bag‑valve‑mask devices. Compact Medical…
    fda medwatch · 11d agoCRLNegative↗ source
  • Ultragenyx cuts 20% of workforce and abandons Wilson disease gene therapy after mixed Q3 results
    Ultragenyx said it will cut about 20% of its workforce, marking a second round of layoffs this year. The reductions will affect roughly a fifth of the company's employees. At the same time, the fi…
    Endpoints · 11d agoLayoffsNegative↗ source
  • Novartis ends $800M neuroscience partnership with BioArctic after 14 months
    Novartis signed an $800 million neuroscience partnership with BioArctic in August 2025, providing $30 million upfront to merge BioArctic’s BrainTransporter technology with a Novartis antibody targe…
    Fierce Biotech · 11d agoDealNegative↗ source
  • Advanced analytics enable up to 12% cut in control animal use while keeping study rigor
    The control group is a cornerstone of nonclinical safety studies, providing the baseline needed to separate a drug’s effects from normal biological variation. Researchers are now applying virtual…
    Fierce Biotech · 11d agoPositive↗ source
  • Teva halts phase 2 trial of emrusolmin for multiple system atrophy after futility analysis
    Teva Pharmaceuticals announced it is stopping a phase 2 study of its experimental small‑molecule drug emrusolmin, which was being tested in patients with the rare neurodegenerative condition multip…
    Fierce Biotech · 12d agoNegative readoutNegative↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 12d agoRegulatoryNeutral↗ source