Company Updates

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Industry Updates

COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events

On 11th March 2021, the European Medicines Agency (EMA) announced its Pharmacovigilance Risk Assessment Committee (PRAC) will be investigating reports of blood clots in vaccine recipients. There is currently no indication that the vaccination was the cause and as the vaccine’s benefits continue to outweigh its risks, it can continue to be administered while the investigation continues.

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MHRA issues responses to the temporarily suspension of AstraZeneca vaccine

On 11th March 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a response to Danish, Norwegian, and Icelandic authorities’ action to temporarily suspend the AstraZeneca COVID-19 vaccine. A further response was issued on the 14th of March, in response to the temporarily suspension of the vaccine in the Republic of Ireland.

EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU

On 11th March 2021, the EMA announced it has recommended granting a conditional marketing authorisation for Janssen COVID-19 Vaccine in people from 18 years of age. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.

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FDA issues update on its ongoing COVID-19 response effort

On 12th March 2021, The U.S. Food and Drug Administration (FDA) announced more actions taken in its ongoing response effort to the COVID-19 pandemic.

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EMA publishes highlights from its Management Board meeting

On 12th March 2021, the EMA published highlights from its Management Board meeting. Highlights include the development of the Clinical Trial Information System (CTIS), and the minor uses / minor species (MUMS) and limited markets scheme for veterinary medicines.

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EMA issues highlights from March PRAC meeting

On 12th March 2021, the EMA published highlights from the PRAC meeting on the 8th-11th March. Highlights include the review of thalassaemia medicine Zynteglo and new safety information for healthcare professionals.

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FDA announces steps to streamline path for COVID-19 screening tools

On 16th March 2021, the FDA announced steps to streamline the path for COVID-19 screening tools. The FDA is providing information for test developers about a streamlined path to emergency use authorisation for these important screening tools as well as information to help these groups as they set up testing programs.

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Issue Number: WN0002

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