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26 April 2021 | 07:22am StockMarketWire.com - Drugmakers AstraZeneca and MSD said their drug to treat neurofibromatosis type I had been recommended for approval in the EU. Neurofibromatosis type I is a genetic disorder of the nervous system that causes tumours to grow on nerves. The recommendation for approval was based on trial of selumetinib that demonstrated an objective response rate of 66% in paediatric patients with neurofibromatosis type 1 inoperable plexiform neurofibromas. Safety and efficacy data from the trial with longer follow up would be provided to the The Committee for Medicinal Products for Human Use as a condition of the recommendation for approval, the company said. ....
26 April 2021 | 07:31am StockMarketWire.com - Pharma giant AstraZeneca said its lung cancer drug had been recommended for marketing authorisation in the European Union. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the Adaura phase III trial evaluating Tagrisso to treat adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer. In the trial, Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with Stage II and IIIA early-stage epidermal growth factor receptor-mutated non-small cell lung cancer, and in the overall trial population of patients with Stage IB-IIIA disease, the company said. ....
14 April 2021 | 08:18am StockMarketWire.com - UK stocks eked out modest gains in early trading on Wednesday after a reasonably tame US inflation reading eased concerns about rising bond yields, offsetting a disappointing earnings release from Tesco. At 0816, the benchmark FTSE 100 index was up 8.28 points, or 0.1%, at 6,898.77. Supermarket group Tesco fell 3.6% to 223.75 as it reported a 20% drop in annual profit after rising grocery sales were offset by lower fuel sales, costs associated with adapting to the pandemic and a writedown at its banking operation. Tesco held its annual dividend steady at 9.15p per share, while forecasting a strong improvement in profitability in the current financial year. ....
14 April 2021 | 07:18am StockMarketWire.com - Pharmaceutical company AstraZeneca said its lung cancer drug had been approved in China after a late-stage study showed the treatment had cut the risk of disease recurrence or death by 80%. In the trial, Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with stage II and IIIA early-stage epidermal growth factor receptor-mutated, or EGFRm, non-small cell lung cancer. The drug also showed a statistically significant and clinically meaningful improvement in disease-free survival in the overall trial population of patients with stage IB-IIIA disease, a key secondary endpoint, the company said. ....
12 April 2021 | 07:49am StockMarketWire.com - Pharmaceutical maker AstraZeneca and Saint Luke s Mid America Heart Institute said high-level results from a phase 3 trial assessing the potential of Farxiga to treat patients hospitalised with COVID-19 failed to meet its primary goal. The trial failed to achieve statistical significance for the primary goal of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days, the company said. The full trial results would be presented at the American College of Cardiology Scientific Sessions in May 2021. Story provided by StockMarketWire.com ....