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3,172 stories matching this filter · ← front page

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  • Biopharma hiring surges in Massachusetts and California, with science/R&D and clinical roles leading demand
    BioSpace data shows that biopharma job postings on its site rose 17% between January and August 2026, signaling a broad increase in employment opportunities. Massachusetts and California dominate…
    BioSpace · 1mo agoNeutral↗ source
  • EU officials outline major pharmaceutical legislative reforms at RAPS Convergence 2026
    At RAPS Convergence 2026 in Charlotte, North Carolina, officials from the European Commission and the European Medicines Agency presented a set of reforms aimed at overhauling the European Union’s…
    raps · 1mo agoRegulatoryPositive↗ source
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  • Bristol Myers ends $100M Phase 1 cancer ADC program
    Bristol Myers Squibb announced it has discontinued development of its Phase 1 antibody-drug conjugate candidate BMS-986497/ORM-6151. The decision follows a review of early clinical data, leading t…
    Endpoints · 1mo agoNegative↗ source
  • CMS offers Medicare pricing program exemptions to drugmakers who add Medicaid rebates
    The Centers for Medicare & Medicaid Services (CMS) has announced that drug manufacturers can be exempted from two Medicare pricing demonstration programs. The exemption is conditional on the compan…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cellares signs first Asian manufacturing deal with Taiwan's GenomeFrontier Therapeutics for CAR-T production
    Cellares announced a new partnership with Taiwanese biotech GenomeFrontier Therapeutics, marking the manufacturer’s first collaboration in Asia. The agreement will see Cellares evaluate and potenti…
    Endpoints · 1mo agoDealNeutral↗ source
  • Webinar Explores Manufacturing Risks and Partner Strategies for the Next Five Years
    The webinar titled "Manufacturing in Turbulent Times" is scheduled for September 17, 2026 and is designed to help biopharma sponsors understand the manufacturing challenges that lie ahead. It note…
    BioSpace · 1mo agoNeutral↗ source
  • Goa Therapeutics launches with $15.5M funding to develop fast-acting alcohol sobering drug
    Goa Therapeutics announced its launch, backed by $15.5 million raised mainly from individual industry leaders, and has filed for an initial public offering that could raise up to $75 million. The…
    Fierce Biotech · 1mo agoPositive↗ source
  • North Immunology to go public via reverse merger, targeting eczema with bispecific antibody
    North Immunology, a private biotech incubated by ADAR1 Capital Management, announced it will become a public company through a reverse merger with Nasdaq‑listed Aethlon Medical. The merged entity…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source
  • CMS launches 10-year ACCESS health-tech pilot for Medicare
    CMS recently held an event to commemorate the summer launch of the ACCESS model, a decade-long pilot aimed at integrating health-technology solutions into Medicare. The program will test new digit…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Endpoints 11 reveals 2026’s most promising biotech startups at Boston gala
    The Endpoints editorial team announced the Endpoints 11 list, highlighting the most exciting biotech startups of 2026. The selection process involved months of research, interviews with executives,…
    Endpoints · 1mo agoNeutral↗ source
  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Bavarian Nordic appoints former Sanofi, AstraZeneca and Pfizer executive Tarja Stenvall as CEO
    Bavarian Nordic announced that Tarja Stenvall will become its president and chief executive, succeeding Paul Chaplin. Stenvall brings decades of experience from senior roles at Sanofi, AstraZeneca…
    Endpoints · 1mo agoNeutral↗ source
  • Experts discuss wet AMD treatment limits and need for longer lasting therapies
    In a recent episode of the Denatured podcast, Professor Philip Jacob Rosenfeld of the University of Miami and Wesley Jackson, chief science officer at Valitor, joined host Jennifer C. Smith-Parker…
    BioSpace · 1mo agoNeutral↗ source
  • Over 15,000 Science/R&D jobs and 10,800 Clinical roles posted on BioSpace in first eight months of 2026
    BioSpace data shows seven biopharma disciplines each had at least 5,000 live postings during the first eight months of 2026. Science/R&D leads with 15,361 positions, ranging from manager roles at…
    BioSpace · 1mo agoNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • General Catalyst outlines tech collaborations with Summa Health after hospital acquisition
    General Catalyst, a venture capital firm, is now describing how it plans to integrate technology with Summa Health following its purchase of the hospital network. The firm says the focus will be o…
    Endpoints · 1mo agoNeutral↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • FDA approves Ultragenyx's gene therapy for Sanfilippo syndrome type A
    The FDA granted full approval to a rare disease gene therapy from Ultragenyx on Thursday, giving the company a much-needed boost in an otherwise difficult year. The therapy, called UX111, will be b…
    Endpoints · 1mo ago↗ source
  • Two more biotechs, Marea and North Immunology, do reverse mergers
    The reverse merger party is still buzzing. This time, it's a cardio and endocrine startup with two drugs in Phase 2 and a biotech working on a long-acting immunology and inflammation (I&I) drug. Mi…
    Endpoints · 1mo ago↗ source
  • Novartis drops $125M for Sironax’s tech to cross blood-brain barrier
    Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
    BioSpace · 1mo ago↗ source
  • Roche turns to Dualitas to find new bispecific approaches for immunology
    Roche is turning up the heat on its hunt for next-generation bispecific antibodies in a deal that will involve screening 300,000 new combinations for inflammatory and immunology conditions. The Swi…
    Endpoints · 1mo ago↗ source