Shares of AstraZeneca plc (ADR) (NYSE:AZN) ended Thursday session in red amid volatile trading. The shares closed down -0.21 points or -0.64% at $32.60 with 6.53 million shares getting traded. Post opening the session at $32.37, the shares hit an intraday low of $32.36 and an intraday high of $32.69 and the price vacillated in this range throughout the day. The company has a market cap of $169.19 billion and the numbers of outstanding shares have been calculated to be 1.26 billion shares.
AstraZeneca plc (ADR) (AZN) on September 1, 2016 announced results from the SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol LABA (long-acting beta2-adrenergic agonist) safety study showing patients with controlled and uncontrolled asthma had a comparable risk of serious asthma-related events and a lower risk of asthma exacerbations when formoterol was combined with budesonide versus budesonide alone.
The study compared the safety of formoterol, a LABA, used in combination with budesonide, an inhaled corticosteroid (ICS)–the two active therapies in SYMBICORT pressurized metered dose inhaler (pMDI)–against budesonide (pMDI) to evaluate the risk of serious asthma-related events. These events are defined as a composite endpoint of asthma related events including asthma-related deaths, intubations, and hospitalizations, with time to first serious asthma-related event as the primary endpoint.
The results showed a comparable risk of serious asthma-related events when formoterol was combined with budesonide versus budesonide alone. Based on a predefined non-inferiority margin, the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) of the primary safety endpoint needed to be less than two. As a result, the findings demonstrated statistical non-inferiority of SYMBICORT to budesonide for time to first serious asthma-related event (HR [1.073], 95% CI, [0.698-1.650]). Furthermore, SYMBICORT therapy resulted in a 16.5% lower risk of asthma exacerbations than budesonide (HR, 0.835; 95% CI, 0.745 to 0.937; P = 0.002).
Full study results are now available in The New England Journal of Medicine. The study began in 2011 as a post-marketing requirement by the U.S. Food and Drug Administration (FDA) and all manufacturers of LABA-containing products indicated for the treatment of asthma in the U.S. were required to conduct similar studies evaluating the safety of LABAs when used in combination with an ICS.
Gregory Keenan, Vice President and Head Medical Officer, US Medical Affairs, said: “These findings reconfirm the well-established safety profile of SYMBICORT as demonstrated in our robust clinical program and extensive post-marketing surveillance from around the world. We are pleased to see the importance of ICS/LABA combination therapy in the management of asthma further validated through this study’s findings and its publication in The New England Journal of Medicine.”
Shares of Medtronic PLC (NYSE:MDT) ended Thursday session in red amid volatile trading. The shares closed down -0.05 points or -0.06% at $86.98 with 3.12 million shares getting traded. Post opening the session at $87.09, the shares hit an intraday low of $86.32 and an intraday high of $87.21 and the price vacillated in this range throughout the day. The company has a market cap of $121.21 billion and the numbers of outstanding shares have been calculated to be 1.39 billion shares.
Medtronic PLC (MDT) announced that it will participate in the Wells Fargo Global Healthcare Conference on Thursday, September 8, 2016, in Boston.
Geoff Martha, executive vice president and president of the Medtronic Restorative Therapies Group (RTG), will answer questions about the company beginning at 8:45 a.m. Eastern Daylight Time.
A live audio webcast of the presentation will be available on September 8, 2016, by clicking on the Investor Events link at http://investorrelations.medtronic.com, and an archive of the session will be available on the same webpage later in the day.