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How close are we to oral biologic drug delivery? Will biomedical devices be essential in overcoming drug delivery challenges? Discover all this and more in this podcast with MIT's Assistant Professor Giovanni Traverso.
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
US FDA grants Enhertu Priority Review based on promising trial results in certain patients with HER2-positive breast cancer.
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.
