news
Gene therapy sustains bleeding control in haemophilia A trial
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.
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Regulation & Legislation
news
Regulators recommend remote inspections for use post-pandemic
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
article
Generic drug market growth: insights to 2030
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.
whitepaper
Brochure: Simplify your compliance process
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
news
EMA recommends RoActemra in adults with severe COVID-19
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
news
FDA authorises Evusheld for COVID-19 prevention
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
whitepaper
Whitepaper: USP method modernisation
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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…
whitepaper
Application note: Catalyst screening in drug development
Learn how to design, plan, execute and analyse catalyst screening experiments in an efficient manner.
whitepaper
Application note: Impurity analysis of L-aspartic acid and glycine
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
news
EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
whitepaper
Whitepaper: Sterility testing – difficult products
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
news
MHRA approves Xevudy (sotrovimab) to treat COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) approve sotrovimab for people with mild to moderate COVID-19 infection and at least one risk factor for developing severe illness.
video
On-demand webinar: AstraZeneca’s fully automated nitrosamine analysis
This on-demand webinar details a qualified automated approach to nitrosamine testing in products, which simultaneously prepares samples for LC-MS and GC-MS.
