Asthma

Regeneron and Sanofi’s Dupixent (dupilumab) Receive the US FDA’s Approval as an Add-On Maintenance Treatment to Treat Moderate-To-Severe Asthma

Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. reduction in the rate of severe asthma attacks @1yrs.; improvement in lung function by 5.32% points @ 12wks. & as early as 2wks. & sustained …

Regeneron and Sanofi’s Dupixent (dupilumab) Receive the US FDA’s Approval as an Add-On Maintenance Treatment to Treat Moderate-To-Severe Asthma Read More »

AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma

Shots: The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged ≥4yrs. in 3132 & 1001 patients with asthma Both trials met its 1EPs i.e., reductions in risk of severe exacerbations in the MANDALA trial, improvement in lung function as measured …

AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma Read More »

AstraZeneca and Amgen’s Tezepelumab Demonstrates 86% Reduction in Exacerbations in Patients with Asthma and Nasal Polyps

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO +SOC in adults (18–80yrs.old) and adolescents (12–17yrs. old) with severe, uncontrolled asthma. The study showed improvements in lung function and nasal polyp symptoms The pre-specified exploratory analysis evaluated the effect of tezepelumab in NAVIGATOR patients with/ out reported nasal polyps (NP+ or NP−) …

AstraZeneca and Amgen’s Tezepelumab Demonstrates 86% Reduction in Exacerbations in Patients with Asthma and Nasal Polyps Read More »

Amgen builds case for severe asthma drug tezepelumab

Amgen and partner AstraZeneca have said their recently filed severe asthma drug tezepelumab has shown impressive results in patients who also have nasal polyps, a common complication of the respiratory disease. Tezepelumab reduced the annualised asthma exacerbation rate (AAER) by 86% in a subgroup of people with severe, uncontrolled asthma and polyps in the NAVIGATOR …

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Sensyne, Oxford University deploy AI to find asthma targets

Oxford University and UK clinical artificial intelligence (AI) company Sensyne Health will partner on a project to find new drug targets for people with hard-to-treat asthma. It’s estimated that almost one in five people with asthma find it difficult to control symptoms using current therapies, while around 4% have particularly severe forms that puts them …

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AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma

Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS The results demonstrated superiority in 1EP …

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma Read More »

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma

Shots: CytoReason reports the initiation of a project with Sanofi by utilizing its cell-centered models and deconvolution techniques to counsel mechanistic insights for each asthma endotype The focus of the project is to drive a better understanding of heterogeneity in asthma patients and identify stable and reproducible asthma endotypes alongwith associated diagnostic features by using …

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Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021

Shots: The P-III VOYAGE trial involves assessing Dupixent (100/200mg, q2w, based on weight) + SOC asthma therapy in 408 children aged 6-11yrs. with uncontrolled mod. to-sev. asthma with evidence of type 2 inflammation Results: improvement in asthma control @24wks. (1.34/ 1.33 vs 0.88/ 1.00); improvement in ACQ-7-IA; reduction in mean FeNO levels to below the …

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021 Read More »

Hikma shares rally after US launch of Advair generic resumes

Shares in Hikma have rallied as it resumed the launch of its generic Advair Diskus in the US, after clearing up a final piece of bureaucracy with the FDA. The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market. Advair …

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Scotland opens door to Translarna for Duchenne muscular dystrophy

A disparity in UK access to a medicine for Duchenne muscular dystrophy (DMD) has been addressed, after Scotland gave a green light to use of PTC Therapeutics’ Translarna for the first time.  The Scottish Medicines Consortium (SMC) says that Translarna (ataluren) can be provided by NHS Scotland for a period of three years, once PTC …

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Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent …

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children Read More »

AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

A US court has upheld AstraZeneca’s patents on its respiratory drug Symbicort, blocking cheaper competition for the ageing blockbuster. The US District Court for the Northern District of West Virginia has decided in favour of AZ in litigation against Mylan Pharmaceuticals and Kindeva, the company said in a statement. Mylan, which is now part of …

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GSK hits trouble with Trelegy as EU regulators block asthma indication

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. It’s a blow for GSK, which hopes that Trelegy (fluticasone furoate+umeclidinium+vilanterol) will help to revive the fortunes of its respiratory diseases franchise. The company had been …

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AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma Read More »

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Shots: The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks. The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma …

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Study: Asthma Patients Maintain High Medication Adherence Using Propeller Health’s Platform

What You Should Know: – New study out from Propeller and Chicago’s NorthShore University HealthSystem shows that asthma patients maintain higher medication adherence and decrease their rescue inhaler use when using a digital health platform. – The study looked at 100 patients recruited from NorthShore practices, half of whom used Propeller to manage their condition …

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Health Innovators: David Van Sickle on digital innovation in respiratory medicine

In the first episode of our Health Innovators series, Paul Tunnah speaks to David Van Sickle, CEO of Propeller Health about how digital technologies are revolutionising the field of respiratory medicine. The post Health Innovators: David Van Sickle on digital innovation in respiratory medicine appeared first on .

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall …

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Aptar Pharma Acquires the Assets of Respiratory Startup Cohero Health

What You Should Know: – Apstar Pharma acquires the assets of respiratory health company Cohero Health to expands its digital portfolio with a focus on respiratory disease management. – Cohero Health develops digital tools and technologies to improve respiratory care, reduce avoidable costs, and optimize medication utilization. AptarGroup, Inc., a global leader in consumer dispensing, …

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AstraZenca Reports Results of Fasenra (benralizumab) in P-lllb PONENTE Trial for Asthma

Shots: It is based on P-lllb PONENTE trial assessing Fasenra (benralizumab, 30mg) in adult patients with severe Asthma on high-dose ICS + LABA and long-term use of OCS therapy with or without additional asthma controller. This study included approx. 600 patients in EU, North America, South America, and Taiwan Results: 62% of patients achieved complete …

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What White Blood Cell Count Should We Shoot for?

At the start of my video What Does a Low White Blood Cell Count Mean?, you can see what it looks like when you take a drop of blood, smear it between two pieces of glass, and view at it under a microscope: a whole bunch of little, round, red blood cells and a few …

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CareLinx, Doctor on Demand Partner to Bring In-Home Virtual Care to Seniors

What You Should Know:  – Doctor On Demand and CareLinx, one of the largest professional networks for in-home care, have announced a collaboration to bring in-home virtual care services to CareLinx clients.  – At a time when seniors have been encouraged to stay home to avoid exposure to COVID, Doctor On Demand’s partnership with CareLinx …

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Innovaccer, CareSignal Partner to Enable Deviceless Remote Patient Monitoring

What You Should Know: – Innovaccer has recently partnered with CareSignal to address healthcare’s urgent need amidst the COVID-19 pandemic: to create and maintain solid, clinically actionable relationships with patients in a new set of predominantly virtual care. – CareSignal offers evidence-based end-to-end support services for chronic medical conditions such as asthma, CHF, COPD, diabetes, …

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Lemonaid Health Raises $33M to Expand On-Demand Consumer Telehealth Platform

– Lemonaid Health, a direct to consumer telehealth company raises $33M in Series B funding to expand the company’s medical team and number of services being offered to patients. – To date, the company has treated more than a million patients online for a variety of medical conditions ranging from erectile dysfunction to sinus infections to …

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Combating Air Pollution Effects with Food

There is a food that offers the best of both worlds—significantly improving our ability to detox carcinogens like diesel fumes and decreasing inflammation in our airways—all while improving our respiratory defenses against infections. Outdoor air pollution may be the ninth leading cause of death and disability in the world, responsible for millions of deaths from …

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Teva launches digital asthma and COPD rescue inhaler in US

Teva has launched new digital inhaler and drug combination in the US, containing built-in sensors that connect to a phone to help manage asthma and COPD symptoms.  Israel-based Teva said the system conveys information to patients, who can use the product branded as ProAir Digihaler (albuterol sulfate) for patients with asthma and chronic obstructive pulmonary disease (COPD).  Teva noted …

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Philips and BioIntelliSense Integrate to Enhance Remote Patient Monitoring

What You Should Know: – Philips integrates the BioIntelliSense FDA-cleared BioSticker™ sensor as part of its remote patient monitoring solutions for patients outside the hospital. – Multi-parameter sensors aid monitoring across multiple chronic conditions with medical-grade vital signs for physicians to remotely track core symptoms, including COVID-19. – Healthcare Highways is the first to leverage …

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Propeller Health, Novartis Co-Package Asthma Medication in Europe for Prescription

What You Should Know: – Propeller Health announced it will co-package a new asthma medication from Novartis, which was approved by the European Commission this week for use in the EU. – Enerzair® Breezhaler® plus Propeller Health sensor is the first asthma medication to be co-packaged and co-prescribed with a digital health platform. – Propeller’s …

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One Way to Treat Asthma and Autoimmune Diseases with Diet

Cutting two teaspoons of salt’s worth of sodium from one’s daily diet can significantly improve lung function in asthmatics In the 1960s and 1970s, a mystery was emerging. Why were childhood asthma rates between 2 to 5 percent in the developed world but as low as 0.007 percent in the developing world? For example, in …

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The Benefits of Slow Breathing

There are all manner of purported hiccup “cures,” which include everything from chewing on a lemon, inhaling pepper, or, our dog’s favorite, eating a spoonful of peanut butter. In my video How to Strengthen the Mind-Body Connection, I talk about the technique I’m excited to try the next time I get hiccups: “supra-supramaximal inspiration,” where …

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