Atzumi (dihydroergotamine) / Shin Nippon Biomedical Labs - LARVOL DELTA

Demand starter data kit: Selected socio-economic and technical energy system demand modelling data for all 47 counties in Kenya. (PubMed, Data Brief) - "As a demonstration, these data were used to calibrate a demand model for Kilifi County using the Model for the Analysis of Energy Demand (MAED) for a baseline scenario from 2019 to 2070. The assumptions used and results gained are illustrated in the appendix of the article as a demonstration of what can be achieved through application of this dataset."

Journal

Transitioning to healthy and sustainable diets has higher environmental and affordability trade-offs for emerging and developing economies. (PubMed, Nat Commun) - "In this study, we project changes in water use, dietary quality, and food affordability under four dietary scenarios (including Mediterranean diet, the EAT-Lancet diet, the Healthy US-Style diet, and Vegetarian diet), assessing the potential implications at the country level from 2020 to 2070...However, in the initial phases, increased food demand escalated water use and worsened food affordability, especially in emerging and developing economies, with the maximum average deterioration being 2.62% and 13.06%, respectively. These highlight the need for long-term planning and financial support to ensure successful global transitions."

Journal

Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine (PRNewswire) - "Satsuma Pharmaceuticals...and its corporate parent, Shin Nippon Biomedical Laboratories...announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101....The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine."

FDA approval • Migraine • Pain

How Long Will You Be a Widow? Determinants, Trends, and Income Gradient in Widowhood Duration. (PubMed, Demography) - "Using French life tables from 1962 to 2070 and simulations based on the Gompertz law and a bivariate Gaussian copula, we assess each determinant's relative influence...Despite converging gender life expectancies, our projections suggest that widowhood duration will remain high until 2070, at 9.2 years for females and 6.2 years for males. Notably, we identify a negative gradient in widowhood duration along the standard-of-living distribution."

Journal

Predicted impact of HPV vaccination and primary HPV screening on precancer treatment rates and adverse pregnancy outcomes in Australia 2010-2070: Modelling in a high income, high vaccination coverage country with HPV-based cervical screening. (PubMed, Vaccine) - "This analysis demonstrates that the benefits of HPV vaccination programs extend beyond prevention of HPV-related disease. HPV vaccination will reduce PTBs and LBW infants, with a further reduction with future twice-lifetime screening for HPV9 cohorts."

Adverse events • Journal • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Obstetrics • Oncology

COMPRESSED VR EXPOSURE THERAPY HABITUATES PTSD SYMPTOMS IN A CRITICAL ILLNESS SURVIVOR (SCCM 2025) - "Her physical activity IPAQ scores improved from 1130 to 2070 but declined to 546 at 3 months after a rheumatoid disease diagnosis...Her outcomes suggest C-VRET may be useful for habituating trauma symptoms in adult critical illness survivors. Further testing with a large, diverse sample is needed."

Cardiovascular • CNS Disorders • Congestive Heart Failure • Depression • Heart Failure • Immunology • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Development of national post-fire restoration system to assess net GHG impacts and salvage biomass availability. (PubMed, MethodsX) - "For 2024 to 2070, we assessed the changes in ecosystem carbon, emissions from harvested wood products, and substitution benefits from avoided emissions-intensive materials, relative to a forward-looking baseline. Our prototype system provides a comprehensive framework, configuration files, links to datasets to quantify the net GHG of post-fire restoration, and sample results for validation.•Developed spatially explicit forest carbon modeling system for all of Canada's forests.•Assessed the net GHG reduction from post-fire restoration.•Used system approach to consider forests, wood products and substitution benefits."

Journal

Development and Validation of a Literature Screening Tool: Few-Shot Learning Approach in Systematic Reviews. (PubMed, J Med Internet Res) - "Our FSL framework demonstrates the potential for reducing workload in SR screening by over 50%. However, the model did not achieve 100% recall at this threshold, highlighting the potential for omitting eligible studies. Future work should focus on developing a web application to implement the FSL framework, making it accessible to researchers."

Journal

Relationship of dihydroergotamine pharmacokinetics, clinical efficacy, and nausea-A narrative review. (PubMed, Headache) - "The maximum concentration and AUC over the first 30 min following DHE administration were associated with increasing rates of 2hPR and a Cmax below ~2500 pg/mL was associated with low incidences of nausea. We suggest that this may be an optimal profile for a DHE delivery form. Further research to test this hypothesis is warranted."

Journal • PK/PD data • Review • CNS Disorders • Migraine • Pain

Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura (PRNewswire) - "Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), are pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted for review a resubmission to original new drug application (NDA) for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura as a complete response to their January 2024 action letter. The Prescription Drug User Fee Act (PDUFA) date is set as April 30, 2025."

FDA filing • PDUFA • CNS Disorders • Migraine

Spatial model of groundwater contamination risks from pit-latrines in a low-income country. (PubMed, Water Res) - "National survey data of over 100,000 water-points and 260,000 pit-latrines in Malawi was used to generate a novel, high-resolution model of pit-latrines from 2020 to 2070 under five population scenarios...The model predicts 8.2 mega-tonnes of faecal nitrogen will be disposed of into subsequently abandoned pit-latrines between 2020 and 2070. Change is necessary to prevent SDG6's push for sanitation undermining its goal of clean water."

Journal

The Impact of Dynamic Mortality on the Cost-Effectiveness of Axicabtagene Ciloleucel Versus Standard of Care As Second-Line Therapy in Patients With Large B-Cell Lymphoma in France (ISPOR-EU 2024) - P3 | "General population mortality from INSEE was simulated in two ways: 1) a static approach where age- and sex-specific mortality data from a single year (2020) was used; and 2) a dynamic approach where year-specific projected mortality for the years 2021 to 2070 was used. Compared to the static approach, using dynamic background mortality resulted in a meaningful reduction in the ICER for axi-cel for 2L LBCL in France. The dynamic approach to modelling should be considered appropriate for French HTA submissions to ensure the impacts of future improvements in health are reflected in estimates of cost-effectiveness."

Clinical • Cost effectiveness • HEOR • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura (PRNewswire) - "Satsuma Pharmaceuticals...announced the resubmission of the new drug application (NDA) for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura...After a Type A meeting to discuss the contents of the CRL, Satsuma and SNBL believe the NDA resubmission addresses all findings in the CRL....In the prior CRL, the FDA noted no concerns related with the clinical trial results, including the safety of STS101, and did not request additional clinical trials. However, the Agency provided additional comments primarily related to formulation (Chemistry, Manufacturing, and Control - CMC)."

FDA filing • CNS Disorders • Migraine • Pain

Satsuma Pharmaceuticals and SNBL Announce Publication of STS101 (Dihydroergotamine Nasal Powder) Pivotal Phase 3 ASCEND Study in CNS Drugs (PRNewswire) - P3 | N=482 | ASCEND (NCT04406649) | Sponsor: Satsuma Pharmaceuticals, Inc | "Study shows the repeated long-term, as-needed use of STS101 for the acute treatment of a migraine attack demonstrated a favorable safety profile and was well tolerated. Exploratory Efficacy Endpoints showed that STS101provided rapid freedom from pain (37% of attacks), and rapid freedom from most bothersome symptoms (54% of attacks) at 2 hours and sustained treatment benefits over 48 hours after dosing....Satsuma Pharmaceuticals, Inc...today announced publication the STS101 ASCEND Phase 3 long-term, open-label safety trial in CNS Drugs. STS101 is the only product to combine Satsuma's proprietary SMART (Simple MucoAdhesive Release Technology) with an easy-to-use, easy-to carry nasal delivery device."

P3 data • CNS Disorders • Migraine • Pain

Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study. (PubMed, CNS Drugs) - P3 | "The repeated long-term, as-needed use of STS101 was well tolerated, demonstrating a favorable safety profile in the acute treatment of migraine attacks in appropriately indicated adults. Exploratory efficacy evaluations indicated beneficial effects, which warrant further evaluation."

Journal • P3 data • Cardiovascular • CNS Disorders • Migraine • Pain • Vascular Neurology

Preference of home delivery of oral PrEP versus clinic pick-up among postpartum South African women (HIVR4P 2024) - "Choices regarding HIV test type; n=169, self-tests:101 (60%) and 68 (40%) rapid clinic tests. Early results demonstrate home delivery of PrEP was often selected among postpartum women. These preferences, along with positive associations between home delivery and reported PrEP adherence suggest it may be a viable option for differentiated PrEP service delivery among this key population."

Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Rising Obesity-Associated Mortality in Men: Exploration of Gender Disparity from the Global Burden of Disease Study, 1990-2019. (PubMed, J Gen Intern Med) - "Overweight/obesity-related morbidity and mortality are higher among male sex. Identifying differences in pathogenesis, complications and treatment response is crucial to develop targeted interventions and equitable public health policies to combat this global burden."

HEOR • Journal • Genetic Disorders • Obesity

Decomposing high uncertainty in greenhouse gas mitigation pathways in emerging regions: An approach to evaluate risks toward carbon neutrality. (PubMed, Sci Total Environ) - "This uncertainty results in a cumulative projection error of 2.1 billion tons of CO2e from 2020 to 2070...In our uncertainty flow analysis, the energy transformation sector is identified as the principal contributor to total uncertainty, driven significantly by economic and energy-related factors. These results underscore the critical need for policymakers in emerging regions to incorporate uncertainty decomposition analysis into their strategic planning to mitigate risks in GHG reduction efforts."

Journal

Evaluation of farmland production potential in key agricultural production areas on the Qinghai-Tibet Plateau under multi-scenario simulation. (PubMed, Sci Total Environ) - "On the basis of the predictions of land use changes from 2020 to 2070, the trade-offs in grain production resulting from bivariate changes in farmland and FPP under future scenarios are analyzed...Furthermore, the compensated farmland quantities and average FPPs under all the scenarios are significantly lower than the amount of occupied farmland. The results provide a theoretical foundation and data support for farmland protection decision-making and layout optimization in the Qinghai-Tibet Plateau."

Journal

Modelling the potential impact of global hepatitis B vaccination on the burden of chronic hepatitis B in the United States. (PubMed, J Viral Hepat) - "We simulated immigrants with HBV infection arriving to the United States from 2000 to 2070 using models of the 10 countries from which the largest numbers of individuals with HBV infection were born...Global hepatitis B vaccination since 2000 reduced prevalence of HBV infection in the United States. Achieving the WHO 2030 infant vaccination goals globally could lead to over one hundred million dollars in additional savings."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Subjects view use of STS101 favorably: subject impression data from the phase 3 open-label ASCEND study (AHS 2024) - P3 | "Subject impression data through 3-, 6-, and 12-months of treatment in the open-label ASCEND study indicate STS101 is viewed very favorably by subjects on multiple attributes. Most subjects considered STS101 easy to use and indicated they would be likely to use the product if it were available. In comparison to their usual migraine medications, subjects indicated that STS101 worked faster and more consistently, and enabled them to more rapidly return to normal."

Clinical • P3 data • CNS Disorders • Migraine • Pain

STS101 (dihydroergotamine nasal powder) shows pain relief in difficult to treat migraine attacks: Results from the phase 3 double-blind, randomized, placebo-controlled summit study (AHS 2024) - P3 | "The results of the SUMMIT study show that STS101 demonstrated significant anti-migraine effects versus placebo on headache pain relief, including in difficult to treat migraine attacks such as migraine with allodynia, menstrually-related migraine, and migraine with severe impact."

Clinical • P3 data • CNS Disorders • Migraine • Pain

STS101 (dihydroergotamine nasal powder) shows long duration anti-migraine benefit on baseline photophobia, phonophobia, and nausea: Results from the phase 3 double-blind, randomized, placebo-controlled SUMMIT study (AHS 2024) - P3 | "The results of the SUMMIT study show that, similar to its effects on migraine headache pain and most bothersome headache-associated symptom, STS101 showed significant anti-migraine effects versus placebo on baseline photophobia, phonophobia, and nausea from 3 through 48 h post-dose."

Clinical • P3 data • CNS Disorders • Migraine • Pain

Long-Term Safety and Tolerability Data of STS101 From the Phase 3 Open-Label ASCEND Study (AHS 2024) - P3 | "The results of the ASCEND study show that STS101 was well tolerated by subjects with migraine when used long-term and as needed. TEAEs were mostly local, mild, and transient with a low discontinuation rate. Table 1: Most Common TEAEs (PTs Reported by ≥5% of Subjects)"

Clinical • P3 data • CNS Disorders • Migraine • Pain

STS101 demonstrated long-term clinical benefit in the phase 3 open-label ASCEND study (AHS 2024) - P3 | "Exploratory efficacy analyses in this long-term safety study show high rates of freedom from pain and MBS through 48 h post dose for STS101. These effects were consistent throughout 12 months of study showing that STS101 is a reliable and effective treatment of acute migraine headache attacks."

Clinical • P3 data • CNS Disorders • Migraine • Pain