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EMA launches the Regulatory Science Research Needs initiative
The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development.
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Regulation & Legislation
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Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
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Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
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Case study: Results from bridging data management gaps
How CMC software helped a major pharmaceutical company improve process development and regulatory submissions.
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Technical note: The content of nevirapine and related impurities
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
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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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.
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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.
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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.
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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.
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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.
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Whitepaper: USP method modernisation
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
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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.
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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…
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Application note: Catalyst screening in drug development
Learn how to design, plan, execute and analyse catalyst screening experiments in an efficient manner.
