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From the Cancer Drug Development Forum (CDDF), John Smyth (Chairman), Axel Glasmacher (Treasurer) and Jaap Verweij (Managing Director) clarify the importance of a collaborative industry approach to cancer therapy development and highlight the most pressing challenges for discussion in their meetings and workshops.
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
BMS’s Orencia (abatacept) has been approved by the US FDA for prophylaxis of acute graft-versus-host disease (aGvHD) in patients aged two years plus.
Here, Dave Elder discusses some encouraging progress in the development of novel excipients, highlighting what this means for the industry.
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…
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
Giroctocogene fitelparvovec had a mean annualised bleeding rate (ABR) of just 1.4 percent over two years, with no bleeding events in the first year post infusion.
The global generics drug market is anticipated to grow to $574.63 billion by 2030, owing to the increasing application of robotic process automation, branded medicine patent expiries and the rising prevalence of chronic diseases.
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals for eplontersen.
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…
The US Food and Drug Administration (FDA) approves Cytalux to help identify cancerous lesions during ovarian cancer surgery.
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…
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.
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
