Nitric oxide

Mallinckrodt plc Reports First Quarter 2024 Financial Results and Reaffirms Full Year Guidance

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木曜日, 5月 9, 2024

DUBLIN, May 9, 2024 /PRNewswire/ -- Mallinckrodt plc  ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the first quarter ended March 29, 2024.1

Key Points: 
  • Mallinckrodt's net sales in the first quarter of 2024 were $467.8 million, as compared to $424.6 million in the first quarter of 2023.
  • Acthar Gel reported net sales of $102.8 million for the first quarter of 2024, representing an increase of 25.4% versus the prior year quarter.
  • Terlivaz reported net sales of $6.0 million in the first quarter of 2024, reflecting Mallinckrodt's successful ongoing launch of the product.
  • Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the first quarter.

Nicox Provides First Quarter 2024 Update and Full Year 2023 Financial Results

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月曜日, 4月 22, 2024

“Nicox made good progress in 2023 as we move towards topline results of the Denali Phase 3 trial which we expect in H2 2025.

Key Points: 
  • “Nicox made good progress in 2023 as we move towards topline results of the Denali Phase 3 trial which we expect in H2 2025.
  • The Nicox Board of Directors has co-opted Dr Gavin Spencer, CEO of Nicox, as a Board member with effect from April 8, 2024.
  • The debt restructuring amendment which was agreed in principle between Nicox and BlackRock and announced on February 28, 2024 was signed.
  • The audit procedures on the 2023 statutory financial statements of Nicox SA have been completed and the certification report is in the process of being issued.

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

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月曜日, 4月 8, 2024

These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.

Key Points: 
  • These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.
  • The beneficial effects of a high intensity statin and EPA on endothelial dysfunction may contribute to reduced atherothrombotic risk in outcome trials.
  • Elevated Lp(a) levels are an independent and causal risk factor for cardiovascular (CV) disease with limited treatments available.
  • The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including among those subjects with elevated Lp(a).

Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides 2024 Guidance

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火曜日, 3月 26, 2024

Adjusted gross profit as a percentage of sales was 62.3% for the fourth quarter of 2023, as compared to 65.9% for the fourth quarter of 2022.

Key Points: 
  • Adjusted gross profit as a percentage of sales was 62.3% for the fourth quarter of 2023, as compared to 65.9% for the fourth quarter of 2022.
  • Mallinckrodt expects fiscal 2024 Acthar Gel net revenue to decline in the low single digits, compared with fiscal 2023.
  • Mallinckrodt received FDA clearance of the INOmax EVOLVE DS Delivery System in the fourth quarter of 2023.
  • Please see the "Reconciliation of Non-GAAP Financial Guidance" included in this release for a reconciliation of GAAP and non-GAAP financial measures for the fourth quarter of 2023 and fiscal 2023.

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

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金曜日, 3月 22, 2024

RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

Health Direct Introduces AminoMind, The First-Of-Its-Kind Nootropic Collagen

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木曜日, 3月 14, 2024

IRVINE, Calif., March 14, 2024 /PRNewswire/ -- Health Direct, makers of AminoSculpt Liquid Collagen, has released the first-ever nootropic collagen, AminoMind. This new form of liquid collagen contains the clinically documented dosage of Brain-derived Neurotropic Factor (BDNF) building nutrients. BDNF creates new brain cells (neurogenesis) and supports new neural pathways and adaptation (neuroplasticity.)

Key Points: 
  • IRVINE, Calif., March 14, 2024 /PRNewswire/ -- Health Direct, makers of AminoSculpt Liquid Collagen, has released the first-ever nootropic collagen, AminoMind.
  • This new form of liquid collagen contains the clinically documented dosage of Brain-derived Neurotropic Factor (BDNF) building nutrients.
  • CollaBrain's dipeptides are the only collagen clinically shown to improve brain health and support BDNF production.
  • It's about supporting your brain's structure," says Jim Caras, founder of Health Direct, "Imagine pouring very expensive water into a bucket with holes.

TikTok claims ‘tongue scrapers’ can cure bad breath – here’s what the evidence actually says

Retrieved on: 
水曜日, 3月 13, 2024

Tongue scraping has long been part of daily hygiene routines in many parts of the world.

Key Points: 
  • Tongue scraping has long been part of daily hygiene routines in many parts of the world.
  • But while there’s some evidence to back these claims, the practise could also come with risks.
  • Poor oral health can lead to a build-up of biofilms containing certain bacterial species which cause dental decay (cavities), gum disease and bad breath.
  • But there’s less evidence showing whether these techniques are also effective for preventing tongue biofilms and bad breath.

Tongue scraping

  • However, these reviews did find that the benefits of tongue scraping were shortlived and needed to be done using a specific technique to be effective.
  • There are other caveats when it comes to tongue scraping.
  • In these instances, tongue scraping will do little to solve bad breath.
  • One study has suggested that tongue scraping may actually enrich the amount of nitrate-reducing bacteria on the tongue.
  • It will be important for further research to be done with more participants to better determine both the potential benefits and harms of tongue scraping.

Should I use a tongue scraper?

  • It’s also likely that the benefits and downsides of using a tongue scraper would differ for each person.
  • Good oral hygiene will probably be enough to fix bad breath – and aggressive tongue scraping may actually risk making your tongue bleed.
  • We also don’t yet fully know how tongue scraping will affect good bacteria on you tongue.
  • Scrape your tongue, or clean your tongue with a toothbrush, with care, if you must.


Zoe Brookes does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

GCANRx Announces Completion of Preclinical Study for Neuropsychiatric Cannabinoid Therapy

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火曜日, 2月 27, 2024

Professor Tal Burstyn-Cohen, Ph.D. of the Hebrew University, through the Yissum Research Development Company, led the preclinical study.

Key Points: 
  • Professor Tal Burstyn-Cohen, Ph.D. of the Hebrew University, through the Yissum Research Development Company, led the preclinical study.
  • The preclinical study aimed to assess the impact of various combinations of the neuroprotective therapeutic in a preclinical model.
  • “We are excited to finally receive the positive results from our preclinical study, which was our first step in validating our novel, cannabinoid based therapeutic,” said Aitan Zacharin, GCANRx CEO.
  • To receive the latest information about GCANRx sign up to the investor email at https://bit.ly/2ZNlBoj or follow @GCANRX on Twitter.

Third Pole Therapeutics Announces Successful Completion of Feasibility Study with eNOfit™ Portable Inhaled Nitric Oxide Delivery System

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火曜日, 2月 27, 2024

This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).

Key Points: 
  • This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).
  • “The successful completion of our EFS which validated the safe and practical use of our eNOfit™ system, enables us to confidently move into larger randomized placebo-controlled safety and efficacy studies.
  • Importantly, this value creating milestone will trigger the final funding of Third Pole’s Series B investment round.” said Bill Athenson, CEO of Third Pole.
  • Inhaled nitric oxide relaxes smooth muscle within the pulmonary vasculature, increasing the diameter of pulmonary arteries and decreasing their resistance to blood flow.

Vivacelle Bio and University of Missouri-Kansas City School of Medicine Announce Groundbreaking Results from Phase 2a Clinical Trial of VBI-S for Refractory Hypotension in Severe Septic Shock Patients

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木曜日, 2月 29, 2024

This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.

Key Points: 
  • This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.
  • Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide.
  • These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients."
  • This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide.