COVID-19 - October 26, 2020
FDA authorises restart of the AZD1222 vaccine US Phase III trial
Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so. The Food and Drug Administration (FDA) authorised the restart in the US, following the resumption of trials in other countries in recent […]
Pharma Business - October 23, 2020
AstraZeneca’s Forxiga recommended for approval in the EU by CHMP for heart failure
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its […]
Pharma Business - October 22, 2020
AstraZeneca’s Trixeo Aerosphere recommended for approval in the EU by CHMP
AstraZeneca’sTrixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting […]
Pharma Business - October 7, 2020
AstraZeneca’s Farxiga granted Breakthrough Therapy Designation
Farxiga (dapagliflozin) has been granted Breakthrough Therapy Designation (BTD) in the US for patients with chronic kidney disease (CKD), with and without type-2 diabetes (T2D). The Food and Drug Administration (FDA)’s BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address […]
Pharma Business - September 21, 2020
Lynparza recommended for approval in EU for BRCA-mutated metastatic castration-resistant prostate cancer
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its […]
Clinical Trials - September 14, 2020
AstraZeneca announces results from Fasenra trial
Results from the OSTRO Phase III trial showed AstraZeneca’s Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra demonstrated a statistically significant improvement in the endoscopic total nasal polyp score (NPS) and the nasal blockage […]
