news
AstraZeneca and Ionis to develop and commercialise eplontersen
AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals for eplontersen.
List view / Grid view
US Food and Drug Administration (FDA)
article
Five marketing strategies for novel therapeutics
Long before the advent of Coronavirus, next-generation therapies were making headlines, but the successful development of COVID-19 vaccines, including mRNA vaccines, has now shone a spotlight on next-generation therapies. This offers a boost to the long-term growth projections for the advanced therapy medicinal products (ATMPs) sector. But although ATMPs hold…
news
FDA approves new imaging drug to identify ovarian cancer lesions
The US Food and Drug Administration (FDA) approves Cytalux to help identify cancerous lesions during ovarian cancer surgery.
article
Technologies and tactics for accelerating end-to-end biologic drug development
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
news
FDA approves first drug to treat common form of dwarfism in children
The US Food and Drug Administration (FDA) approves vosoritide injection to improve growth in children at least five years of age with achondroplasia and open epiphyses.
news
European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
article
Social media is transforming our understanding of drug safety
Here, Daniel Ghinn of CREATION.co discusses the growing role social media analysis is playing in helping to provide pharmaceutical companies and health regulators with real-world evidence on drug safety.
article
Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
news
FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
news
IV suramin may be a promising autism treatment, shows Phase II study
PaxMedica's intravenous (IV) suramin known as PAX-101 had mixed results in Phase II study, but shows potential to reduce autism symptoms.
news
FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
article
Continuous biomanufacturing – where are we now?
The biopharmaceutical industry is driven by the need to increase production and reduce costs, while maintaining product quality – and has increasingly been focused on intensification of processes to accomplish this goal. In this article, European Pharmaceutical Review’s Hannah Balfour summarises the potential benefits of implementing continuous bioprocessing and manufacturing…
article
Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
news
FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
news
Comirnaty® booster dose displays high efficacy in Phase III study
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
