CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
Phase IIb study results show evidence of sustained, durable complete responses beyond one year with an intravesical gemcitabine delivery system for a high-risk bladder cancer.
Topline results from a Phase III study in NSCLC suggest that Rybrevant® and lazertinib could advance treatment beyond tyrosine kinase inhibitor (TKI) monotherapy.
Johnson & Johnson has updated the branding for its Janssen division, enabling its pharmaceutical and medtech segments to modernise and be more connected to its J&J brand.
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
Winners of ISPE's Facility of the Year Awards (FOYA) 2022 include Janssen, Takeda, CRISPR Therapeutics, Catalent and Iovance Biotherapeutics.
Janssen has announced plans to initiate a large-scale study into the impact of psoriasis among black, Hispanic, Asian, indigenous and other people of colour.
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
Why are precision medicines important? What challenges face their development and manufacture? Where could they be in 10 years? Discover all this and more in this podcast with Janssen!
Tremfya inhibited radiographic progression and provided durable improvements in symptoms of axial involvement in psoriatic arthritis patients.
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
The investigational respiratory syncytial virus (RSV) vaccine candidate demonstrated 80 percent efficacy in adults aged 65 and older.
In this article, European Pharmaceutical Review’s Hannah Balfour explores some of big pharma’s latest developments in HIV treatment, with commentary from ViiV Healthcare’s Head of Research and Development, Kimberly Smith.
Erleada achieved an 86 percent reduction in PSA at 12 months in the majority of patients, shows post-hoc analysis of Phase III study.