news
New ethical guidance for paediatric clinical trials
New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
List view / Grid view
Research & Development (R&D)
video
On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
news
AbbVie Cork facility €60 million expansion
The Irish biopharmaceutical plant was given a special update for its pivotal 20th anniversary, expanding the site to offer its future workforce training in new technology.
news
Pfizer 20vPnC vaccine as safe as Prevenar 13®
The paediatric pneumococcal conjugate vaccine (20vPnC) can help protect against all 20 pneumococcal disease-causing serotypes, says Pfizer.
whitepaper
Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
news
FDA and NIH partner to understand ALS
The Critical Path for Rare Neurodegenerative Diseases (CP-RND) partnership was launched to develop breakthrough treatments for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).
webinar
Validation and implementation of a novel automated PCR technology for mycoplasma testing
22 September 2022 | By bioMérieux
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
news
First patient dosed with HIV gene therapy
According to researchers, the CRISPR-based gene therapy, EBT-101, has the potential to change the future of HIV therapeutics.
article
Using RWE in rare disease drug development: effective innovations with historical controls
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
news
First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
news
Zuranolone shows promise as episodic treatment for depression
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
webinar
Addressing analytical control challenges for different plasmid DNA products
16 September 2022 | By GenScript ProBio
Learn how to develop an analytical control strategy for different plasmid DNA product applications with GenScript ProBio, a global CDMO in cell and gene therapy industry.
news
AbbVie’s Skyrizi® shows long-term efficacy in psoriatic arthritis
Similar rates of skin improvement at week 100 indicate Skyrizi® (risankizumab) has consistent long-term efficacy in psoriatic arthritis patients.
news
Novartis’ Kisqali® provides “unparalleled survival benefit” in breast cancer
A pooled exploratory analysis shows Kisqali® plus endocrine therapy adds a year to overall survival of patients with aggressive form of breast cancer.
podcasts
EPR Podcast Episode 14 – Breast cancer drug development – Markus Kosch, Daiichi Sankyo
What unmet need remains in breast cancer and how is drug development helping tackle these challenges? Tune in to this episode with Daiichi Sankyo to find out more.
