Biopharmaceuticals

OncoBayes Advances OB-001 to Clinic After 400% Brain Exposure Gain

LONDON – – October 07, 2026 -- OncoBayes has completed preclinical work on OB-001, an oral drug candidate designed to overcome antibody-drug conjugate (ADC) resistance and boost brain penetration of tyrosine kinase inhibitors (TKIs), the privately held clinical-stage pharmaceutical company announced.

OB-001 raises osimertinib brain exposure by nearly 400% in mouse studies

In perfused-brain mouse models, pretreatment with OB-001 increased brain exposure of osimertinib by almost 400%, while plasma exposure remained broadly unchanged. The data, presented at AACR 2026, covered four gold-standard kinase inhibitors and showed systemic drug levels were largely unaffected by the efflux-pump inhibition.

LG CNS Unveils Pharma Smart Factory AI Suite at CPHI Milan 2026

Milan – October 07, 2026 -- LG CNS is showcasing a pharma-specific manufacturing automation suite at CPHI Milan 2026, the world's largest pharmaceutical and biotech trade show, as the Korean AI transformation firm expands into drug-manufacturing technology. The company is the only Korean participant in CPHI's newly created "AI & Tech" zone this year, presenting its booth under the theme "Autonomous Factory in Pharma."

CPHI Milan draws 60,000 visitors and 3,000 exhibitors from 160 countries

The Milan event is CPHI's flagship show, held annually across global venues including the United States, Europe, Asia and the Middle East, and is considered the premier gathering for pharma and biotech manufacturing technology.

Astellas to Present 21 Oncology Abstracts at ESMO 2026

Tokyo – October 06, 2026 -- Astellas Pharma Inc. (TSE: 4503) will present 21 abstracts from its oncology portfolio at the European Society for Medical Oncology Congress 2026, running October 23-27 in Madrid, Spain.

Enfortumab vedotin combination shows longest follow-up data yet in urothelial cancer

Presentations on PADCEV (enfortumab vedotin) plus pembrolizumab include the longest follow-up reported to date for patients with locally advanced or metastatic urothelial cancer, alongside subgroup and treatment-setting analyses. Additional data cover trials in progress evaluating bladder preservation strategies in muscle-invasive bladder cancer.

BioMarin, Jazz, Otsuka CEOs Join NORD Summit Rare Disease Panel

Washington, D.C. – October 06, 2026 -- CNBC's Becky Quick will moderate a rare disease leadership dialogue featuring the CEOs of BioMarin, Jazz Pharmaceuticals and Otsuka North America Pharmaceutical alongside NORD CEO Pam Gavin, the National Organization for Rare Disorders announced.

Panel convenes three biopharma chiefs at NORD's Breakthrough Summit on October 26

The session, titled "Next Decade of Rare Disease: A CEO Leadership Dialogue," takes place at 11 a.m. ET on Monday, October 26, in Washington, D.C., during the three-day NORD Rare Diseases & Orphan Products Breakthrough Summit running October 25–27. Participants include Alexander Hardy, President and CEO of BioMarin; Renee Gala, President and CEO of Jazz Pharmaceuticals; Tarek Rabah, President and CEO of Otsuka North America Pharmaceutical; and NORD CEO Pam Gavin.

Halozyme Expands argenx Deal to Eight Exclusive ENHANZE Targets

San Diego – – October 06, 2026 -- Halozyme Therapeutics (Nasdaq: HALO) has expanded its global collaboration and license agreement with argenx, adding two new exclusive targets for its ENHANZE drug-delivery platform and raising the partner's total exclusive target count from six to eight.

Halozyme adds two exclusive ENHANZE targets to argenx licensing deal

The expanded agreement builds on the companies' existing collaboration, which already delivered VYVGART Hytrulo, a subcutaneous treatment for myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Under the new terms, Halozyme is eligible for milestone payments tied to development and regulatory progress on the additional targets, plus royalties on future net sales of any resulting products using ENHANZE.

Enliven Secures FDA Alignment on Phase 3 CML Trial Design

Burlingame, Calif. – October 06, 2026 -- Enliven Therapeutics, Inc. (Nasdaq: ELVN) has reached alignment with the U.S. Food and Drug Administration on the final design of ENABLE-2, a pivotal Phase 3 trial testing relcobatinib against standard second-generation therapies in previously treated chronic myeloid leukemia (CML). The company remains on track to initiate the trial before year-end 2026.

FDA clears path for 450-patient head-to-head comparison

ENABLE-2 is designed to enroll approximately 450 adults with CML who have already received one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib at 80 mg once daily or an investigator-selected second-generation TKI -- dasatinib, nilotinib, or bosutinib. The primary endpoint is major molecular response (MMR) at Week 24, with MMR at Week 96 as a key secondary measure.

CMS Grants NTAP Reimbursement for icotec's CMORE CT Spine Implant

Altstätten, Switzerland and Boston – October 06, 2026 -- The Centers for Medicare & Medicaid Services has approved a New Technology Add-On Payment for icotec's CMORE® CT spine implant system, effective October 1, 2026, opening expanded reimbursement access for eligible hospitals treating Medicare patients.

CMS reimbursement decision follows April 2025 Break-Through Device Designation

icotec's CMORE® Cervicothoracic System received FDA Break-Through Device Designation in April 2025, a status that preceded the latest NTAP approval. The NTAP program provides eligible hospitals additional payment for qualifying technologies used in traditional Medicare procedures, applying here to specified spinal conditions and surgeries.

C5 Biomedical CEO Named AATB '50 at 50' Honoree

Boca Raton, Fla. – October 06, 2026 -- C5 Biomedical LLC CEO Tim Maye, CTBS, is being honored tonight in San Francisco as one of 50 individuals named to the Association for Advancing Tissue and Biologics' (AATB) one-time "50 at 50" list, marking the organization's 50th anniversary.

Maye's 28-year tissue banking career includes six years chairing AATB's Standards Committee

Maye has held his Certified Tissue Bank Specialist (CTBS) credential since 1999 and spent six years chairing AATB's Standards Committee, the body responsible for the tissue banking standards the industry operates under today. He founded C5 Biomedical in 2021 and remains on the Standards Committee.

Luminous Mind Wins Patent for Non-Hallucinogenic Psychedelic Mushrooms

Boston – October 06, 2026 -- Luminous Mind, Inc. (LMI) has secured U.S. Patent No. 12,697,362, covering technology that produces non-hallucinogenic psychedelic fungi, targeting a functional mushroom market Grand View Research values at $38.2 billion for 2025.

Patent strips psilocybin while preserving secondary metabolites

The patent isolates beneficial compounds found in psilocybin-containing mushrooms -- secondary metabolites and active fungal molecules typically overshadowed by the hallucinogen. By removing psilocybin, LMI says the resulting products retain potential nutraceutical benefits without triggering hallucinations, opening a path to mass-market commercialization that psychedelic-based products cannot access under current regulatory frameworks.

ARUP Labs Wins Redtail AI Supercomputer Access for Cancer Diagnostics

Salt Lake City – October 06, 2026 -- ARUP Laboratories has secured a spot in the second cohort of challenge projects on Utah's Redtail AI Factory, gaining access to a supercomputer ranked No. 159 globally to accelerate a proprietary diagnostic AI model for blood cancer detection.

ARUP's EventHorizon model targets faster, more accurate blood cancer diagnosis

The project, titled "Scaling EventHorizon with Redtail: A Foundation Model for Clinical Flow Cytometry," aims to build a foundation model that helps pathologists interpret complex flow cytometry data used to diagnose blood cancers and other hematologic diseases. The tool is being developed by a team at the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine, including David Ng, MD, FCAP, and research data scientists Muir Morrison and Mattia Medina Grespan.