Advanced Therapies

A lower asking price from BMS and more insight into the benefits Breyanzi offers have convinced the health technology assessment institute, NICE, to reverse its rejection of the one-off treatment for large B-cell lymphoma.

Nonprofits are finding new ways to address market gaps and develop treatments for rare diseases with little commercial attraction.

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

Gingko Bioworks has released a large language model designed to improve mRNA stability.

Beyond the cost savings of biosimilars, the true evolution in wet AMD treatment is happening by companies developing next-generation therapies that aim to reduce injection burden, introduce novel mechanisms, and potentially alter disease progression.

Any tariff headwinds should be counterbalanced by currency tailwinds, predicts German imaging and diagnostics company Siemens Healthineers.

China has granted its first approval for a stem cell therapy, to domestic firm Platinum Life Biotech’s umbilical cord-derived mesenchymal stem cell product for corticosteroid-failed acute graft-versus-host disease with gut involvement.

CARsgen's anti-Claudin 18.2 CAR-T therapy satricabtagene autoleucel has met its endpoint in a pivotal Phase II trial in later-stage gastric/gastroesophageal junction adenocarcinoma, paving the way for a China NDA filing.

The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.

The HTA Co-ordination Group will explain how developers can request joint scientific consultations.