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The cessation of manufacturing activities follows a Sun Pharma recall and reports that regulators found fault with the company’s quality system.

In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after the higher dose failed to deliver the same benefit.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

Sail Biomedicine’s $925 million deal with Johnson & Johnson helped boost the cell and gene therapy sector over biologics in terms of venture capital fundraising in the third quarter.

Bioscience employment rose in 41 states, though not in California, according to a new report from the Biotechnology Innovation Organization and the Council of State Bioscience Associations.

After a year of controversial regulatory reversals, the FDA has accepted uniQure’s application for ifezuntirgene inilparvovec for priority review, with a May 1 action date. If approved, the therapy—also called AMT-130—would be the first disease-modifying treatment for Huntington’s disease.

A fresh FDA review for Biohaven’s embattled ataxia drug lifted the biotech’s shares, while a late-stage lung cancer miss battered ArriVent, which failed to rebound even after encouraging early ADC data.

With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ Akeso-partnered PD-1xVEGF antibody, one analyst calls the asset “the next major backbone” of cancer treatment.

Former biologics boss Peter Marks had a vision. With the FDA’s latest draft guidance, it’s coming to fruition. Speaking with BioSpace, current CBER leader Karim Mikhail said the “adapted pathway” is designed to develop personalized gene therapies more quickly.

Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ecosystem, despite regional political instability. Whether it can produce sustainable biotech companies and a resilient manufacturing base for global production remains an open question, but the future looks bright.

Two-year agreement and approximately US$198,000 in potential purchases while opening established UK first-aid, medical-supply, workplace and education channels Highlights • Definitive agreement signed October 28, 2026 appoints Poole Bay Holdings Ltd. as exclusive UK distributor of VIVI Epi™ for an initial 24-month term, subject to UK regulatory requirements. • Contractual minimum purchase to maintain exclusivity. The initial two-year minimum volumes represent approximately US$198,000 in potential purchases. • Poole Bay Holdings reports 20 specialist e-commerce sites and more than 30,000 products, spanning first-aid, medical, health and safety, and workplace supplies. • Poole Bay has a network of 15,000 schools across the UK, and will be providing VIVI Epi to these locations • UK Food Standards Agency research estimates approximately 2.4 million adults have a clinically confirmed food allergy, highlighting the scale of allergy-management needs [1]. • The agreement provides for launch sampling, planned promotional activity and a framework to pursue institutional and consumer channels, subject to registrations and market adoption.