International Space Station, March 2009. Backlit view of the ISS with solar array. Artist . (Photo by Heritage Space/Heritage Images via Getty Images)
Heritage Images via Getty Images
Vast, a startup trying to build the world’s first commercial…
Author: admin
-
Journal of Medical Internet Research
Introduction
Abundant evidence has demonstrated that regular physical activity (PA) benefits patients with cancer by improving quality of life, enhancing aerobic fitness, supporting mental health, and reducing common treatment-related side effects…
Continue Reading
-
Why a mild brain injury can trigger Alzheimer’s
New research from the University of Virginia School of Medicine is revealing why traumatic brain injury increases the chance of developing Alzheimer’s disease – and the discovery is pointing to a potential strategy to prevent…
Continue Reading
-
James And Ricks Honored For Saint Francis Women’s Basketball As NEC Prime Performers
Women’s Basketball | 12/15/2025 3:32:00 PM
Aleah James and Shelby Ricks, members of the Saint…
Continue Reading
-
Funeral and visitation plans set for former Houston news anchor Dave Ward – Houston Public Media
Longtime Houston news anchor Dave Ward in the Houston Matters studio in 2019. Dave Ward, a longtime former television news anchor for ABC13, died over the weekend, the Houston station announced. His funeral services are planned for later…
Continue Reading
-
Exdensur (depemokimab) approved in the UK for treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps
GSK plc (LSE/NYSE: GSK) today announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Exdensur is now approved in two indications:
- as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on maximum moderate-dose or high-dose inhaled corticosteroids (ICS) plus another asthma controller;
- as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.
The approval is based on data from the SWIFT and ANCHOR phase III trials which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab. Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.1,2
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: “Today’s UK approval of Exdensur, the first in the world, has the potential to redefine care for millions of patients. This ultra-long-acting biologic delivers sustained efficacy to reduce asthma exacerbations, keep patients out of hospital and help prevent cumulative lung damage in just two doses a year. This is a step change in respiratory treatment, and we look forward to additional regulatory decisions expected in the US, Japan, EU and China.”
Asthma affects more than 260 million people globally3 and about 7 million people in the UK,4 a portion of whom have type 2 inflammation characterised by an eosinophilic phenotype.5 Approximately half continue to experience symptoms and exacerbations despite treatment.6 Asthma exacerbations place a significant resource burden on healthcare systems due to emergency department visits and hospitalisations, with an estimated 22% increase in NHS costs by 2031.7 With the potential to reduce asthma exacerbations, including those leading to hospitalisations, and alleviate the debilitating symptoms associated with CRSwNP, Exdensur could improve patient outcomes while contributing to a reduction in health system burden.
The pooled results from the SWIFT trials showed a 54% reduction in clinically significant exacerbations (asthma attacks) over 52 weeks [rate ratio 0.46, 95% confidence interval (0.36, 0.59), nominal p<0.001] (AER depemokimab = 0.51 exacerbations per year versus placebo = 1.11).1 Additionally, this pooled analysis showed a 72% reduction [RR 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER: depemokimab = 0.02 versus placebo = 0.09) in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or emergency department visit compared to placebo.1 In AGILE, an open-label 12-month extension study, depemokimab maintained the results seen in SWIFT-1 and SWIFT-2, confirming the sustained safety and efficacy of a twice-yearly dose of depemokimab over the course of two years.
Pooled results from the ANCHOR trials showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference -0.7, 95% CI (-0.9, -0.4), nominal p<0.001] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [treatment difference -0.24, 95% CI (-0.39, -0.08), nominal p=0.003].2
Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.1,2
Depemokimab recently received a positive CHMP opinion in the EU and it is currently under regulatory review in other countries, including in the US, Japan and China. Decisions on these approvals are expected starting in December 2025 and continuing through H1 2026.
About asthma with type 2 inflammation
Asthma affects more than 260 million people globally, many of whom continue to experience symptoms and exacerbations despite treatment.8,9 Severe asthma is defined as asthma that requires treatment with medium- to high-dose inhaled corticosteroids plus a second therapy (i.e., systemic corticosteroid or biologic) to prevent it from becoming uncontrolled, or which remains uncontrolled despite therapy.10 Type 2 inflammation is the underlying cause of pathology in more than 80% of patients with severe asthma, in which patients exhibit elevated levels of eosinophils (a type of white blood cell).11
About CRSwNP
CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.12,13 People with CRSwNP experience debilitating symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.12,13 Similar to asthma, the majority of cases of CRSwNP (85%) are driven by chronic type 2 inflammation, which is strongly associated with comorbidities, more severe disease, recurring symptoms and tissue remodelling.14
About Exdensur (depemokimab)
Exdensur is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation, such as severe asthma. It combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life to enable twice-yearly dosing.1 IL-5 is a key cytokine in type 2 inflammation.
More information can be found in the Exdensur Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
About the SWIFT phase III trials
Results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.
The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care (SOC) treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.1
About the ANCHOR phase III trials
Results from the ANCHOR trials were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.
ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.
All 528 patients had inadequately controlled CRSwNP, including nasal polyps in both nasal cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous surgery for CRSwNP, had received previous treatment with SCS or were intolerant to SCS. Patients received depemokimab or placebo at six-monthly intervals (26 weeks) in addition to SOC (maintenance intranasal corticosteroids).2
About the depemokimab development programme
Depemokimab is currently being evaluated in phase III trials for the treatment of other diseases with underlying type 2 inflammation, including OCEAN for eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome (HES). GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III trials assessing the efficacy and safety of depemokimab as an add-on therapy in patients with uncontrolled moderate to severe COPD with type 2 inflammation.
About GSK in respiratory
GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression.
Continue Reading
-
U.S. Legislation Subjects Directors and Officers of Foreign Private Issuers to Section 16(a) Reporting Obligations | Insights
On December 10, 2025, the U.S. House of Representatives passed the National Defense Authorization Act for Fiscal Year 2026 (the NDAA). The NDAA is a broad policy bill that authorizes spending levels, policies, and authorities for key military and national security activities for the upcoming fiscal year. However, buried within the sweeping legislation is Section 8103, Disclosures by Directors, Officers, and Principal Stockholders, or the Holding Foreign Insiders Accountable Act (the HFIAA). Under the HFIAA, Section 16(a) of the Securities Exchange Act of 1934 (the Exchange Act) will be amended to subject directors and officers of foreign private issuers (FPIs) to the Securities and Exchange Commission (SEC) reporting requirements on Forms 3, 4, and 5.
The NDAA is now headed to the Senate for approval, which is expected to happen prior to the upcoming holiday break. The amendments under the NDAA will take effect 90 days after it is signed into law.
Key Requirements of Section 16(a) of the Exchange Act
Section 16(a) of the Exchange Act requires directors, officers, and 10% beneficial owners (collectively, insiders) of a public company’s listed equity securities to publicly report their ownership and transactions in such public company’s securities. These insiders are required to report their initial ownership in the public company’s equity securities on SEC Form 3 in connection with an initial public offering by the date the registration statement becomes effective or, for already public companies, within 10 calendar days of becoming a reporting person under Section 16. In addition, these insiders are required to report subsequent transactions in the public company’s equity securities (e.g., purchases and sales, gifts, and compensation-related transactions, including equity compensation grants and other transactions in connection with such equity compensation grants) on SEC Form 4 within two business days of the relevant transaction. They must also report annually certain other transactions that were not reported on either SEC Forms 3 or 4, on SEC Form 5 within 45 days of the public company’s fiscal year end.
Violations of Section 16(a)
Late or missing filings of Section 16 reports constitute a violation of the securities laws by the individual responsible for making the filing and can draw SEC scrutiny to the FPI, particularly in cases where there are multiple or frequent violations. The SEC has recently focused on untimely filings of Section 16 reports, announcing last year several enforcement actions against individuals – and the affiliated public companies that had undertaken to file on their behalf – for failure to timely file Section 16 reports. The SEC ultimately has broad authority to enforce the securities laws and is permitted to seek “any equitable relief that may be appropriate or necessary for the benefit of investors.”
Impact on FPIs: Additional Transparency for Equity Ownership and Compensation
Historically, insiders of FPIs were exempt from the Section 16(a) reporting requirements, the Section 16(b) short-swing disgorgement rules, and the Section 16(c) short-sale restrictions, each of which apply to insiders of U.S. domestic public companies. While the NDAA does not go so far as to subject FPIs to Section 16(b) (for short-swing profit liability) or 16(c) (for short-sale restrictions), directors and officers of FPIs will soon be required to report changes in their individual beneficial ownership, including any equity compensation awards received. The NDAA does not, however, extend Section 16(a) reporting requirements to 10% beneficial owners of FPIs.
More broadly, FPIs have historically not been required to report the individual compensation of their directors and officers unless such disclosure was required to be made in their home country, and an individual’s equity ownership in the FPI was not required to be disclosed unless it exceeded 1% of the FPI’s total outstanding class of shares. In many cases, equity compensation represents a significant portion of an officer’s overall compensation from a company, and, via Section 16 reporting, such compensation will now be made publicly available. For many insiders, this will represent the first time they need to publicly disclose their individual shareholdings.
The HFIAA does include a new provision that allows the SEC the authority to exempt any person, security, or transaction from Section 16 reporting obligations if the SEC determines that the laws of a foreign jurisdiction apply “substantially similar requirements” to such person, security, or transaction. However, it is not clear what “substantially similar” means or how likely it will be that the SEC grants such an exemption.
Key Considerations
These changes represent a significant departure for the way FPIs report director and officer compensation and will create new filing obligations for directors and officers of FPIs. Below are a few key points to consider in connection with the implementation of the HFIAA:
- FPIs should revisit who they have designated as “executive officers” in their disclosure and in connection with the adoption of their clawback policies as those same officers will now be subject to the above Section 16 reporting requirements.
- FPIs should start to prepare for the implementation of these reporting requirements by enrolling their directors and officers in EDGAR Next, to the extent they are not already enrolled for purposes of electronically filing Forms 144, to ensure each director and officer is appropriately set up to make filings with the SEC.
Continue Reading
-
Wrestling Wraps Up 2025 Calendar With Wednesday Dual at Duke
BOONE, N.C. — App State Wrestling’s final competition before the new year is a Wednesday evening…
Continue Reading
-
Tickets Available for Lion Baseball Auction Presented by WiseGuys Daiquiris
HAMMOND, La. – The Southeastern Louisiana University baseball program is set to host the annual Lion Baseball Auction presented by…
Continue Reading
-
Soil bacteria and fungi emerge as a top predictor of childhood allergic disease
Growing evidence suggests that getting cozy with soil microbes, especially as kids, can guard against allergic disease. Credit: Jenna Stensland
Researcher contact:
Joshua Ladau, Arva Intelligence, [email protected] (UTC-8 hours)AGU press…
Continue Reading