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Moderna COVID-19 vaccine approved by MHRA for use in adolescents, MHRA
This extension to the current UK approval of the Moderna (Spikevax) vaccine covers use in 12- to 17-year-olds. The vaccine was authorised for use in 12-17 year olds in Northern Ireland on 23 July via the approval from the European Medicines Agency. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - August 19, 2021 Category: Consumer Health News Source Type: news

Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies' COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. (Source: World Pharma News)
Source: World Pharma News - August 16, 2021 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

EMA investigating link between Pfizer and Moderna vaccines and three new conditions
THE PFIZER and Moderna Covid vaccines have been integral to turning the tide on the pandemic in the UK and beyond. The efficacy of the vaccines far outweigh the vanishingly small risk of developing a complication, but three new conditions have been linked to the Covid vaccines. The European Medicines Agency is actively investigating the link. (Source: Daily Express - Health)
Source: Daily Express - Health - August 15, 2021 Category: Consumer Health News Source Type: news

ECDC and EMA update on COVID-19, EMA
Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant. With the increasing circulation of the Delta variant of SARS-CoV-2 in EU/EEA countries, the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) strongly encourage those who are eligible for vaccination but have not yet been vaccinated to start and complete the recommended COVID-19 vaccination schedule in a timely manner. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - August 9, 2021 Category: Consumer Health News Source Type: news

FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) ...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news