Markets & Regulations

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Asia-Pacific attracts 50% of global clinical trials

By Jane Byrne

The Asia-Pacific (APAC) region was the largest contributor to the global clinical trial landscape from 2017 to 2021, accounting for more than 50% of conducted trials during the analysis period, found research by GlobalData.


AstraZeneca gains first approval for Evusheld as COVID-19 treatment

By Rachel Arthur

AstraZeneca's long-acting antibody combination Evusheld has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection: marking the first global marketing approval of...


Philadelphia’s CGT sector highlights future talent needs

By Rachel Arthur

Employment in Greater Philadelphia among cell and gene therapy companies has more that doubled since 2019, while employees at contract manufacturing organizations have grown by nearly 40%. Continuing to build the workforce will be crucial as the area...


WHO recommends two mAbs in fight against Ebola

By Rachel Arthur

The World Health Organization (WHO) has published its first guidelines for Ebola virus disease therapeutics, issuing ‘strong recommendations’ for the use of two monoclonal antibodies.


Pfizer and BioNTech submit Omicron booster EUA application to US FDA

By Rachel Arthur

Pfizer and BioNTech have completed their application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine: saying they stand ready to start shipping...

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EMA evaluating Skycovion COVID-19 vaccine

By Jane Byrne

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.


GSK ups sales guidance on back of Shingrix strength

By Ben Hargreaves

GSK’s first quarter following the demerger of its consumer health business sees the company raise its 2022 sales guidance to between 6-8%, up from 5-7% on its previous estimation.

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FDA reviewing higher dose Hyrimoz biosimilar

By Jane Byrne

The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.


Vertex to acquire ViaCyte, targeting type 1 diabetes

By Rachel Arthur

Vertex Pharmaceuticals will acquire ViaCyte, a privately held biotech focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320m.