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Thomas' Biotech Briefing
BIO coverage tracks FDA language, biotech dealmaking, and AltruBio’s PSGL-1 antibody as clinical and partnership talks advance.
The top 10 stories from Thu Jun 25, 2026 06:55 AM to Fri Jun 26, 2026 06:56 AM
Generated June 26, 2026 at 6:56 AM
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#1 BIO 2026: FDA’s IND initiative is a step toward normalization after slipshod year Published 2026-06-25 The FDA under the Trump administration has launched an investigational new drug (IND) pilot program, which former regulators cite as a move toward normalcy in policymaking. Covered by: biospace.com |
#2 Two Claudin 18.2 ADCs Enter Final Stretch Of Global Race With China NDA Published 2026-06-25 Two anti-Claudin 18.2 antibody-drug conjugates are approaching potential world-first approvals in China, with final regulatory steps underway. Covered by: insights.citeline.com |
#3 Labs see rising demand for nitrosamine, topical performance and microbiome testing Published 2026-06-25 BioSpace conference discussions indicate sponsors are seeking earlier safety, quality, and performance data, driving increased demand for nitrosamine analysis, IVRT/IVPT testing, and microbiome database capabilities. Covered by: biospace.com |
#4 Automating Clinical Decisions For Healthcare System Efficiencies Published 2026-06-26 A persistent gap remains between computer science research and clinical practice, limiting the translation of research advances into routine healthcare decision-making. Covered by: insights.citeline.com |
#5 BIO 2026: AltruBio believes that its PSGL-1, a T-cell checkpoint targeting antibody, could be a "ceiling raiser" in the I&I space Published 2026-06-25 AltruBio CEO Judy Chou said the company’s second-generation PSGL-1 antibody targets a T-cell checkpoint and discussed its ongoing UC clinical program and potential collaboration talks in I&I. Covered by: biotechtv.com |
#6 BIO Notebook: More US FDA Wordplay, Big Pharma Helps Entrances, Biotech M&A Offers Exits Published 2026-06-25 The final day of the BIO International Convention featured discussions on US FDA-related regulatory language, Big Pharma’s role in supporting biotech events, and biotech M&A activity. Covered by: insights.citeline.com |
#7 BIO 2026: FDA Leadership Confront Workforce Losses, China Competition in Drug Development Published 2026-06-25 At a BIO 2026 town hall in San Diego, FDA acting leaders discussed workforce stabilization after staffing losses and departures, alongside regulatory reform priorities for rare diseases amid U.S.-China biotech competition. Covered by: genengnews.com |
#8 CStone Pharmaceuticals Enters into Exclusive Commercialization Agreement with Arrotex for Sugemalimab across Australia and New Zealand Published 2026-06-25 CStone Pharmaceuticals appointed Arrotex to handle registration, market access, and commercialization of sugemalimab in Australia and New Zealand under an exclusive agreement. Covered by: prnewswire.com |
#9 FDA’s uniQure, REGENXBIO reversals could bolster other near-term rare disease applications Published 2026-06-25 The FDA’s revised evidence expectations for approving rare disease drugs may accelerate near-term approvals for companies including Skyhawk Therapeutics, Capricor Therapeutics, and Biohaven. Covered by: biospace.com |
#10 AFRRI/NIAID Designs Proprietary PBI-BM2.5 Protocol to Evaluate Valion Bio's (NASDAQ: VBIO) Entolimod as the First and Only Treatment for GI-ARS Published 2026-06-25 AFRRI and NIAID designed a proprietary PBI-BM2.5 protocol to evaluate Valion Bio’s entolimod for GI-ARS using validated animal models. Covered by: prnewswire.com |
