Could a Direct-to-Consumer Sensor Improve Adherence?
In March, Adherium received 510(k) clearance from FDA for over-the-counter (OTC) sales of its Smartinhaler sensor for AstraZeneca’s Symbicort aerosol asthma inhaler and is now preparing to sell its sensor-based solution directly to patients. The sensor, which has since been rebranded as Hailie, fits around a patient’s inhaler “a bit like a jacket,” explains CEO Arik Anderson. The Bluetooth-enabled sensor can be integrated into any inhaler and pairs with an app on a smartphone (see below right) to provide “coaching support” such as dosing reminders and alerts, he told MD+DI. It can c...
Source: MDDI - July 6, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news

Budesonide-Formoterol Used As Needed Beneficial in Mild Asthma
THURSDAY, May 17, 2018 -- Inhaled combined budesonide-formoterol used as needed is beneficial for mild asthma, according to two studies published in the May 17 issue of the New England Journal of Medicine. Paul M. O'Byrne, from McMaster University... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 17, 2018 Category: Pharmaceuticals Source Type: news

AstraZeneca inks outcomes-based contract with Highmark for COPD, asthma drug
Health insurer Highmark inked an outcomes-based contract with AstraZeneca (NYSE:AZN) for Symbicort, the pharmaceutical company’s drug designed to treat asthma and chronic obstructive pulmonary disease. Highmark said its contract with AstraZeneca is one of the first outcomes-based deals involving a respiratory drug and will apply to commercial members of its national and core markets in Pennsylvania, West Virginia and Delaware. Get the full story at our sister site, Drug Delivery Business News. The post AstraZeneca inks outcomes-based contract with Highmark for COPD, asthma drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat AstraZeneca plc Source Type: news

FDA clears Adherium ’ s inhaler sensor for OTC sales
The FDA gave Adherium (ASK:ADR) the go-ahead to launch over-the-counter sales of its Smartinhaler sensor for AstraZeneca‘s (NYSE:AZN) Symbicort asthma inhaler, the company touted last week. Adherium’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and date that a patient uses their inhaler and transmits the data to an app on the user’s phone or tablet. This feature allows users and physicians to track a patient’s medication usage patterns, according to Adherium. Get the full story at our sister site, Drug Delivery Busin...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat Adherium Limited AstraZeneca plc Source Type: news

Adherium receives OTC clearance for AstraZeneca's Symbicort inhaler
Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca ’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort. (Source: mobihealthnews)
Source: mobihealthnews - April 2, 2018 Category: Information Technology Source Type: news

Adherium to expand in U.S. market with direct-to-consumer push for smart inhaler tech
Adherium Ltd. (ASK:ADR), which sells a smart inhaler technology in Europe and Australia, is reportedly looking to jump into the direct-to-consumer U.S. market in the first half of this year. The New Zealand-based company has a deal with AstraZeneca (NYSE:AZN) to combine its Smartinhaler monitoring device with the Symbicort inhaler, but CEO Arik Anderson told MobiHealthNews that he is also looking for other opportunities to penetrate the U.S. market. Get the full story at our sister site, Drug Delivery Business News. The post Adherium to expand in U.S. market with direct-to-consumer push f...
Source: Mass Device - January 25, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat Adherium Limited AstraZeneca plc Source Type: news

AstraZeneca wins FDA nod to remove boxed warning from asthma drug label
After reviewing results from trials involving more than 41,000 asthma patients, the FDA has agreed to remove the boxed warning of serious asthma-related outcomes for AstraZeneca‘s (NYSE:AZN) Symbicort product. Patients using Symbicort, which combines an inhaled corticosteroid and a long-acting beta2-adrenergic agonist in a single inhaler, did not experience a significant increase in the risk of a serious asthma-related event, according to data from four clinical trials. Get the full story at our sister site, Drug Delivery Business News. The post AstraZeneca wins FDA nod to remove boxed warning from asthma drug l...
Source: Mass Device - December 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat AstraZeneca plc Source Type: news

FDA clears Adherium's third inhaler sensor, for AstraZeneca's Symbicort inhaler
Melbourne, Australia-based Adherium, a digital health company that focuses in improving medication adherence and patient outcomes, has just received FDA clearance for a new inhaler monitoring device for AstraZeneca ’s Symbicort aerosol inhaler, dubbed the SmartTouch for Symbicort.   (Source: mobihealthnews)
Source: mobihealthnews - September 1, 2017 Category: Information Technology Source Type: news

Adherium wins 510(k) clearance for smart inhaler monitoring device
Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler. The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. Get the full story at our sister site, Drug Delivery Business News. The post Adherium wins 510(k) clearance for smart inhaler monitoring device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 1, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat Adherium Limited AstraZeneca plc Source Type: news

AstraZeneca gets marketing nod for asthma drug Symbicort
Results from AstraZeneca's two clinical studies have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbation. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 20, 2017 Category: Pharmaceuticals Source Type: news

Symbicort (budesonide and formoterol) for the Treatment of Asthma
Symbicort (budesonide and formoterol) is an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) indicated for the treatment of asthma in paediatric patients aged between six and 12 years. The drug was discovered and developed by AstraZe … (Source: Drug Development Technology)
Source: Drug Development Technology - February 17, 2017 Category: Pharmaceuticals Source Type: news

FDA OKs Symbicort for Uncontrolled Asthma in Kids 6 to 12 FDA OKs Symbicort for Uncontrolled Asthma in Kids 6 to 12
Symbicort (budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg) has a safety profile in children 6 to 12 similar to that in older children and adults.FDA Approvals (Source: Medscape Med Students Headlines)
Source: Medscape Med Students Headlines - January 30, 2017 Category: Universities & Medical Training Tags: Pulmonary Medicine News Alert Source Type: news

Symbicort Approved for the Treatment of Asthma in Patients 6 to 12 Years of Age
26 January 2017 -- AstraZeneca today announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol. The FDA’s decision was based... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 26, 2017 Category: Drugs & Pharmacology Source Type: news

Symbicort granted paediatric exclusivity in the US
AstraZeneca today announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol. The FDA's decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (Source: World Pharma News)
Source: World Pharma News - January 26, 2017 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

GSK, Innoviva seek EU nod for triple combo inhaled therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S. The triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatm...
Source: Mass Device - December 5, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Respiratory AstraZeneca plc GlaxoSmithKline plc Innoviva Source Type: news

GlaxoSmithKline ’ s triple combo with Innoviva tops Symbicort Turbohaler in COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) yesterday touted results from a Phase III study investigating the triple-combination therapy fluticasone furoate/umeclidnium/vilanterol for patients with chronic obstructive pulmonary disease. The 1,810-patient Fulfil study is a randomized, double-blinded trial comparing once-daily FF/UMEC/VI against AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler, a twice-daily combination of budesonide and formoterol. Patients in the FF/UMEC/VI arm showed improved lung function and fewer of the exacerbations normally seen in COPD patients. After 24 weeks...
Source: Mass Device - September 7, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Research & Development AstraZeneca plc GlaxoSmithKline plc Innoviva Source Type: news

No Increase in Serious Asthma Events Seen With Symbicort (CME/CE)
(MedPage Today) -- Safety study of LABA/ICS therapy was requested by FDA (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - September 1, 2016 Category: Pediatrics Source Type: news

AstraZeneca reports positive top-line results from two trials of symbicort
AstraZeneca has reported positive top-line results from two international, multicentre studies of symbicort to treat chronic obstructive pulmonary disease (COPD) and asthma. (Source: Drug Development Technology)
Source: Drug Development Technology - August 11, 2016 Category: Pharmaceuticals Source Type: news

Symbicort (Budesonide and Formoterol Fumarate Dihydrate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 6, 2016 Category: Drugs & Pharmacology Source Type: news

BF Spiromax Compared to BF Turbuhaler for Persistent AsthmaBF Spiromax Compared to BF Turbuhaler for Persistent Asthma
A new study compares the use of two inhalers for delivering budesonide and formoterol in patients with persistent asthma. How do they stack up? BMC Pulmonary Medicine (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - April 25, 2016 Category: Allergy & Immunology Tags: Pulmonary Medicine Journal Article Source Type: news

budesonide/formoterol hfa inhaler (Symbicort)
Title: budesonide/formoterol hfa inhaler (Symbicort)Category: MedicationsCreated: 3/2/2005 12:00:00 AMLast Editorial Review: 10/20/2015 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - October 20, 2015 Category: Respiratory Medicine Source Type: news

budesonide/formoterol hfa inhaler (Symbicort)
Title: budesonide/formoterol hfa inhaler (Symbicort)Category: MedicationsCreated: 3/2/2005 12:00:00 AMLast Editorial Review: 10/20/2015 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - October 20, 2015 Category: Drugs & Pharmacology Source Type: news

Regular vs As-Needed Budesonide/Formoterol in Stable AsthmaRegular vs As-Needed Budesonide/Formoterol in Stable Asthma
In patients with moderate stable asthma, as-needed budesonide and formoterol therapy is less effective than the regular budesonide and formoterol treatment that's recommended by the 2014 revision of the Global Initiative for Asthma guidelines. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 29, 2014 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

Budesonide - Formoterol Used As Needed Beneficial in Mild Asthma
Superior to terbutaline with respect to asthma control, non - inferior to budesonide for exacerbations (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - November 11, 2014 Category: Respiratory Medicine Tags: Family Medicine, Internal Medicine, Emergency Medicine, Nursing, Pediatrics, Pharmacy, Pulmonology, Journal, Source Type: news

EC's CHMP Recommends Combo Inhalers for COPD, AsthmaEC's CHMP Recommends Combo Inhalers for COPD, Asthma
The committee has endorsed the combination of aclidinium bromide/formoterol fumarate for COPD, and a budesonide/formoterol combination for COPD and asthma. International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 26, 2014 Category: Consumer Health News Tags: Pulmonary Medicine News Alert Source Type: news

Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety...
LifeScienceIndustryResearch.com adds “Symbicort (Asthma) - Forecast and Market Analysis to 2023” to its store. Report provides Sales information covered for the US, France, Germany, Italy, Spain, the...(PRWeb September 20, 2014)Read the full story at http://www.prweb.com/releases/symbicort-asthma-forecast/market-analysis-to-2023/prweb12184403.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - September 20, 2014 Category: Pharmaceuticals Source Type: news

CHMP Issues Positive Opinion for Teva's DuoResp Spiromax
Teva Pharmaceuticals announced it has received opinion from theEuropean Medicines Agency's(EMA)Committee for Medicinal Products for Human Use(CHMP) for marketing authorization of its treatment DuoResp®Spiromax®(budesonide & formoterol fumarate dihydrate) inhalation powder. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - February 26, 2014 Category: Pharmaceuticals Source Type: news

Budesonide/Formoterol Therapy in AsthmaBudesonide/Formoterol Therapy in Asthma
Asthma sufferers in Asia and beyond may benefit from this one-two punch combo. Find out why. BMC Pulmonary Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 9, 2013 Category: Consumer Health News Tags: Pulmonary Medicine Journal Article Source Type: news

AstraZeneca - Fourth Quarter and Full Year Results 2012
LONDON, Jan. 31, 2013 - Financial performance for the full year reflects the loss of exclusivity on several brands. At constant exchange rates (CER), revenue declined by 15 percent and Core EPS declined by 9 percent Brilinta/Brilique, Symbicort,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 31, 2013 Category: Pharmaceuticals Source Type: news