International – Pfizer doses first patients with mRNA-based influenza vaccine

Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically offer only 40% to 60% protection, with...

International – Generic industry group wants clarity on ICH bioequivalence guideline

The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...

International – Report predicts a biosimilar « turning point » in 2022

Though last year saw fewer market entrants in the biosimilar space than years past, Cardinal Health still called it one of the “most eventful”...

International – WHO launches R&D efforts to identify pathogens that could cause future pandemics

Disease X represents an unknown pathogen that could have the potential to cause the next global pandemic. Discussions began on Friday 18 November and WHO...

International – International regulators and WHO: support healthcare professionals to enhance public confidence in...

EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed...

International – ICH adopts Q9 guidelines on quality risk management

The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM)...

International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out

Emphasising that the global pandemic is ‘not over’, the ACT-Accelerator’s Council Tracking and Accelerating Progress Working Group – co-chaired by Indonesia and the US...

International – ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products –...

The objective of this guideline is to provide harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products....

International – How will war in Ukraine affect global biopharma industry?

As Russian tanks rumbled into Ukraine early on the morning of February 24, the world knew that there was war. The turmoil has rippled...

International – Biosimilars, are they comparable to their reference counterparts?

Biologicals such as rituximab and trastuzumab have improved treatment outcomes for many cancers. However, due to their high economic burden, ‘highly similar’ products known...

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