Here are the biggest stories to feature on BioPharma-Reporter during April:
1. Gilead produces 97% on-spec Yescarta
The difficulties in the manufacture of CAR-T treatments have become increasingly understood as the breakthrough technology has been commercialised, but Kite’s head of medical affairs told us its process is nearly flawless.
2. Chinese biotechs moving ahead of Europe
The pace at which the Chinese biotech ecosystem is growing has been missed by Europeans, suggested one executive at BIO-Europe Spring.
3. Novo Nordisk invests $100m in Kalundborg site
The Danish company invested in the rebuild of its existing facilities and plans to add further production equipment at its site in Kalundborg.
4. Biosimilar for Soliris approved in Russia after development collaboration
The first-ever Soliris biosimilar approved in Russia, after it was produced through Selexis’ SureTechnology platform and cell line.
5. Teva’s migraine med given marketing authorization
Teva’s anti-CGRP migraine drug lines up next to its competitors, after the European Commission granted it marketing authorization.
6. BioAtla and BeiGene partner on immunotherapy
BeiGene partnered with BioAtla to develop and commercialise the latter’s CTLA-4 antibody, which will be explored for use alongside a PD-1 antibody.
7. Biogen stops developing Alzheimer’s drug
Biogen halts all clinical trial activity on its Alzheimer’s drug, aducanumab, after its failure in Phase III trials.
8. T-cell amplifier receives orphan drug designation
US FDA granted orphan drug designation for Hyleukin-7, an immuno-oncology agent that boosts T cell production and functionality, for the treatment of ICL.
9. Roche reports strong start to 2019
Despite increased competition from biosimilars in Europe, Roche announced sales of its pharmaceutical divisions are up by 10%.
10. Infant death in trial yet Novartis anticipates no threat to approval
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.
