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Spine BioPharma, Inc. Announces Completion of Enrollment for Phase 3 Clinical Trial of SB-01 to Address Chronic Low Back Pain NEW YORK--(BUSINESS WIRE)--Spine BioPharma, Inc., a development stage company committed to non-opiate, non-surgical therapies for Degenerative Disc Disease (DDD), today announced the completion of enrollment of its U.S. Phase 3 clinical trial of SB-01 For Injection (SB-01). The Phase 3 MODEL trial (MOderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year period. SB-01 is the first intradiscal pha via Business Wire Health: Medical Devices News

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Imagine not being able to breathe? 1 out of every 10 children has asthma. Have questions about asthma? Did you know it’s the number one cause of absenteeism in schools? Join the American Lung Association for Asthma Education What does the U.S. Department of Education say about #school environments for #children with asthma? Schools should be, “Ensuring the educational environment is free of a student’s asthma triggers.” Let’s learn more about asthma in educational environments. Did you know the common cold is the number one trigger for an #asthma episode? How can we help prevent this and other triggers in indoor environments? SAFE Indoors Campaign and the ASAP Council and Indoor Air Care Advocates

Exciting News in Cardiovascular Research! Today marks a significant milestone as a groundbreaking small molecule drug, CardiolRx™ currently in Phase II trials for recurrent pericarditis, receives Orphan Drug Designation from the FDA. This achievement underscores its potential to transform the lives of patients. Kudos to the team at Cardiol Therapeutics Inc. for their dedication. 👇Learn more about this groundbreaking development and the ongoing MAvERIC-Pilot study in the comments below. #MedicalInnovation #healthcareadvancements #cardiovascularresearch

We are thrilled to announce that Cadrenal Therapeutics, Inc. has received FDA Orphan Drug Designation (ODD) for tecarfarin, our novel blood thinner, aimed at preventing thromboembolism and thrombosis in patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts.    This designation not only provides potential market exclusivity for up to seven years after approval, but also opens up expanded partnering opportunities for tecarfarin.    At Cadrenal, we are deeply committed to addressing unmet needs in anticoagulation therapy. With this second FDA ODD, we're one step closer to making a meaningful difference in the lives of patients with rare cardiovascular conditions who require chronic anticoagulation.    Read more about this milestone: https://lnkd.in/gkdCV25y   #CadrenalTherapeutics #FDAODD #OrphanDrugDesignation #novelbloodthinner #Tecarfarin #HealthcareInnovation #CVKD Quang Pham

We are thrilled to announce that Cadrenal Therapeutics, Inc. has received FDA Orphan Drug Designation (ODD) for tecarfarin, our novel blood thinner, aimed at preventing thromboembolism and thrombosis in patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts.    This designation not only provides potential market exclusivity for up to seven years after approval, but also opens up expanded partnering opportunities for tecarfarin.    At Cadrenal, we are deeply committed to addressing unmet needs in anticoagulation therapy. With this second FDA ODD, we're one step closer to making a meaningful difference in the lives of patients with rare cardiovascular conditions who require chronic anticoagulation.    Read more about this milestone: https://lnkd.in/gkdCV25y   #CadrenalTherapeutics #FDAODD #OrphanDrugDesignation #novelbloodthinner #Tecarfarin #HealthcareInnovation #CVKD Quang Pham

CREATION.co's medicine launch tracker provides a monthly glimpse into the views of HCPs on new treatments, from our analysis of the social media conversations of millions of physicians, pharmacists and nurses. And it's still free of charge - just follow CREATION.co to get this and our other updates in your feed.

I am thrilled to share an exciting announcement from our Pharmaceutical Diagnostics business - the FDA has approved GE HealthCare's Flyrcado™ (flurpiridaz F 18) injection in the US, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD) – the most common type of heart disease. This milestone achievement has the potential to expand clinician and patient access to PET MPI. It is an important moment in molecular imaging as we continue our journey to address unmet patient needs and advance more precise, personalized care. Learn more about this announcement in our press release: https://lnkd.in/eah2zxyk. Select Important Safety Information Adverse Reactions • Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Find here the full prescribing information: https://lnkd.in/esE7VVKX #GEHealthCare #radiopharma #precisioncare

Listen in from a PBM's perspective! Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, touches on the recent FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar.

Discounts for the Neuromodulation Summit 2024 expire this Friday! 📢 Check out the full event guide now: https://ter.li/rw1ht3 This exclusive conference is industry’s must-attend meeting to join the community of 80+ experts in neuromodulation to share crucial insights into: ✅ How the CDRH is accelerating patient access to innovation ✅ How to overcome regulatory and clinical challenges to receive funding ✅ How the adoption of invasive and non-invasive devices differs ✅ How to choose which submission type is the best first step Joined by the likes of FDA, LivaNova, Axonics, Inc., Cognito Therapeutics, Inc., Neuspera Medical Inc., ClearPoint Neuro, Inc. and many more - this is not one to miss! Save up to $400 on your pass and join them in Boston this June: https://ter.li/wummg3