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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

On Tuesday, the EMA said it had accepted a request from AZ and withdrawn the company’s marketing authorization for its COVID-19 shot Vaxzevria.

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GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic.

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EC grants marketing authorisation for GSK’s RSV vaccine Arexvy

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.

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EC grants marketing authorisation for Takeda’s dengue vaccine

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. According to the results, the trial met the primary endpoint of overall vaccine efficacy by averting 80.2%

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EMA grants full marketing authorisation for AstraZeneca’s Covid-19 vaccine

Pharmaceutical Technology

The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU).

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Pfizer RSV vaccine gets off to fast start on market

Bio Pharma Dive

The pharma’s shot Abrysvo made over $300 million in sales during the first few months of its launch, and will be an important product to help offset declining COVID vaccine sales.

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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.