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  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 2d agoDealNeutral↗ 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 · 3d agoDealNeutral↗ source
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Nephrology735
  • Alethio Therapeutics secures $90 million to develop treatments for rare blood cancers
    Alethio Therapeutics, a UK based biotechnology startup, announced it has raised $90 million in new financing. The capital will be used to advance its pipeline targeting myeloproliferative neoplasm…
    BioPharma Dive · 4d agoDealPositive↗ source
  • MDCG issues guidance on clinical evidence for orphan in-vitro diagnostics
    The Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
    raps · 4d agoRegulatoryNeutral↗ 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 · 4d agoLayoffsNegative↗ source
  • Novo Nordisk lifts 2026 profit outlook after Wegovy obesity pill beats forecasts
    Novo Nordisk announced on Wednesday that it is raising its full-year profit and sales guidance after the third-quarter results for its Wegovy obesity pill came in above analysts' expectations. The…
    BioPharma Dive · 4d agoEarningsPositive↗ 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 · 5d 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 · 5d 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 · 4d agoDealPositive↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 5d agoRegulatoryNeutral↗ 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 · 6d agoDealNegative↗ source
  • Vertex, ahead of FDA decision, calms fears surrounding kidney drug
    On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
    BioPharma Dive · 5d agoEarningsNeutral↗ source
  • FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliff
    The U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…
    BioPharma Dive · 6d agoRegulatoryNeutral↗ 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 · 7d agoNegative readoutNegative↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 9d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 9d agoDealPositive↗ source
  • Sanofi eyes 'moonshot' drug acquisitions to offset upcoming Dupixent patent loss
    Sanofi's CFO Francois-Xavier Roger told Fierce that the company is looking at 'moonshot' treatments as potential acquisition targets to rebuild its pipeline. The push comes as the U.S. patent on D…
    Fierce Biotech · 10d agoDealNeutral↗ source
  • Aspen Neuroscience raises $140M IPO to advance Parkinson’s cell therapy
    Aspen Neuroscience, a San Diego biotechnology company, completed an initial public offering, selling roughly 9.4 million shares at $15 each and raising about $140.6 million. The capital will be di…
    BioPharma Dive · 10d agoDealPositive↗ source
  • Roche launches VENTANA BAP1 test to improve mesothelioma diagnosis
    Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated ready‑to‑use immunohistochemistry assay designed for differential diagnosis of mesothelioma. The assay targets the…
    Fierce Biotech · 10d agoPositive↗ source
  • Third Rock partner’s brain cancer diagnosis highlights personal impact of biotech drug development
    Jigar Raythatha, a partner at Third Rock Ventures, was diagnosed with a rare form of brain cancer in 2023 after a routine MRI. On the same day his diagnosis was confirmed, Servier announced posit…
    Fierce Biotech · 10d agoPositive↗ source
  • Setara Biosciences raises $90M Series A to advance neuroscience pipeline after Jazz's $820M Actio acquisition
    Jazz Pharmaceuticals completed an $820 million purchase of Actio Biosciences in September, creating a new spinout called Setara Biosciences to house the remaining drug programs. Setara has secured…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 10d agoNeutral↗ source
  • FDA releases draft guidance to streamline approval of personalized gene therapies
    The FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
    BioPharma Dive · 11d agoRegulatoryPositive↗ source
  • FDA proposes new rare disease framework to accelerate therapy development
    During a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…
    Fierce Biotech · 11d agoRegulatoryPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 11d agoNeutral↗ source