Macro
Revised EU/Pfizer/BioNTech Covid-19 vaccine deal may lead to a Comirnaty monopoly
The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the…
Catalent CEO drops FY2023 revenue forecast by $450m after “disappointing” quarter
Catalent’s (Somerset, NJ, US) CEO has admitted to the company’s “disappointing” and “poor performance” over the past quarter, and dropped…
SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine,…
Medsenic amends licence agreement with Phebra for arsenic trioxide
Biotechnology company BioSenic’s affiliate Medsenic has amended its licence agreement with Australia-based pharmaceutical company Phebra for the oral formulation of…
Novavax receives positive opinion from CHMP for full MA of Covid vaccine
Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full…
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WuXi Biologics and InflaRx to jointly manufacture Covid-19 therapy Gohibic
WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients.…
Singapore’s HSA extends interim authorisation for Novavax’s Covid-19 vaccine
The Singapore Health Sciences Authority (HSA) has extended interim authorisation for Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in individuals…
WHO declares end of Covid-19 public health emergency
The World Health Organization (WHO) announced the end of the public health emergency for Covid-19, marking the end of a…
FDA revokes EUAs of Pfizer/BioNTech’s and Moderna’s original Covid-19 vaccines
The FDA recently announced the expansion of the emergency use authorizations (EUAs) of both Pfizer/BioNTech’s and Moderna's bivalent original/Omicron BA.4/5…
Atea secures Fast Track designation for Covid-19 drug bemnifosbuvir
The US Food and Drug Administration (FDA) has granted Atea Pharmaceuticals’ bemnifosbuvir a Fast Track designation for Covid-19 as the…