From a potential functional cure for Type 1 Diabetes to accelerated UK approvals – Weekly Round-up

A step closer to a functional cure for Type 1 Diabetes?

Sana Biotechnology has released first-in-human data showing that its hypoimmune-modified allogeneic islet cell therapy enabled sustained insulin production in a type 1 diabetes patient for over a year without the need for immunosuppression. The therapy is designed to evade immune detection, addressing one of the biggest challenges in allogeneic cell transplantation. This signals progress towards scalable, allogeneic approaches that reduce complexity and cost compared to autologous therapies.

Read more via European Pharmaceutical Review  and Biospace →
 

Japan conditionally approves first stem cell therapy for Parkinson’s disease

Japan has granted conditional approval to the first stem cell-derived therapy for Parkinson’s disease, marking a major milestone for regenerative medicine in neurodegenerative disorders. The therapy is currently being evaluated in clinical trials in the U.S, highlighting growing global alignment in this space. This approval reinforces Japan’s position as a global leader in accelerated regulatory pathways, it also signals increasing confidence in cell therapies for neurological conditions.

Read more via APDA →
 

Apertura and Viralgen partner on next-generation AAV capsid for CNS therapies

Apertura Gene Therapy and Viralgen have announced a strategic collaboration to manufacture TfR1 CapX, a next-generation AAV capsid designed to enable more efficient delivery of gene therapies into the central nervous system. Delivery remains one of the biggest limitations in gene therapy, particularly for CNS diseases. Advances in capsid engineering could significantly improve targeting, dosing efficiency and safety profiles while also reducing manufacturing burden. This partnership reflects a broader industry push toward novel vector design as key lever for unlocking new indications and improving commercial viability.

Read more via PR Newswire →
 

AstraZeneca builds end-to-end cell therapy manufacturing capability in China

AstraZeneca has announced plans to establish a commercial-scale therapy manufacturing and supply base in Shanghai, making it the first global pharmaceutical company with end-to-end cell therapy capabilities in China. The site will support the production and delivery of advanced therapies within the region.

Read more via Biopharma Dive and AstraZeneca →
 

UK launches joint MHRA-NICE approval pathway to accelerate patient access

The MHRA and NICE have launched a new aligned approval pathway (launching 1st April), enabling medicines to reach patients 3-6 months faster by running regulatory approval and reimbursement decision sin parallel rather than sequentially. The pathway also introduces integrated scientific advice and earlier engagement with developers, aiming to reduce delays and provide clearer guidance on evidence requirements. Faster approvals improve time-to-market, investor confidence and commercial viability, this also strengthens the UK’s position as a competitive hub for advanced therapies.

Read more via NICE →