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Local Spain
3 days ago
- Business
- Local Spain
EXPLAINED: The changes to Spain's bank ATMs that start in June
Have you ever seen a cash point at a height that is accessible to people in wheelchairs? Or with headphones or audio guides? You may do in Spain in the future. From June 28th 2025, withdrawing cash in Spain will change, with modifications made to cash points intended to help the elderly, people with physical or mental disabilities or those with fewer digital skills. Unlike other, more cashless countries, paying in efectivo remains the most common form of payment in Spain, according to data from the Bank of Spain. For this reason, cajeros (ATMs or cash points in Spanish) are still very popular here, especially with older people, who tend to pay more in cash. Often, however, this can present some practical problems for them, as well as for disabled people. Fortunately, changes in line with Spain's Accessibility Law come into force from 28th June. The changes will be carried out gradually as the law distinguishes between new and existing cash points. Banks have been notifying their customers about which ATMs are already adapted and which ones are still awaiting improvements, so that customers know in advance and can avoid unnecessary trips. Changes to Spain's 'accessible ATMs' In line with Spain's accessibility legislation, the following improvements will be made to cash points in Spain. The text on screen will be larger, especially for people with visual impairments The brightness of the screen will be adjusted to ensure better visibility The icons and interface, i.e. the design of the menus and what we see on the screen, must be as intuitive as possible The buttons must be raised Headphones for voice instructions designed for blind people Accessible height for wheelchair users, including platforms if necessary Staff trained in providing assistance to people with 'functional diversity' It will be up to the banks or ATM operators such as Servired, 4B or Euro 6000 to implement the changes or face fines if they do not. All new ATMs must include these improvements, while existing ATMs have to be modified by 2030. According to Ángel Sánchez, a lawyer and partner at Golden Partners, a firm specialising in real estate and financial law, these changes "require the user to receive, before entering their PIN, clear and detailed information about the transaction: the exact amount, fees, responsible entity, and applicable conditions. "Until now, this information "was not always displayed in advance or in full," Sánchez told El Debate. It therefore "reinforces the principle of banking transparency and protects the financial consumer's right to make fully informed decisions." However, not all of the ATM are necessarily desirable. "Without a doubt, this regulation is part of a broader strategy—although not always stated—of progressively reducing the use of cash in favour of electronic payments," warns Sánchez. "The truth is that it helps normalise a completely digital banking experience, even for those who don't want it or can't afford it." In Sánchez's opinion, "the main legal and social risk lies in the erosion of the right to financial anonymity, the increasing surveillance of consumer habits, and the potential exclusion of vulnerable groups such as the elderly, people with little digital knowledge, or residents of rural areas without access to adapted banking services." ATMs and bank branches in Spain are also disappearing at an alarming rate, especially in rural areas, with 2,000 cash points being lost every year. This has also been blamed on Spanish banks shift to digital as a means of cutting costs. Around 300,000 people spread across 2,500 villages in Spain have no ATMs in their municipalities.
Yahoo
26-05-2025
- Climate
- Yahoo
Cove water main break leads to Disaster Declaration
COPPERAS COVE, Texas (FOX 44) – A Declaration of Local Disaster and an Order for Stage 4B Implementation has been issued after a water main break in Copperas Cove. The city says a public notice was released on May 1, announcing a pending temporary upgrade to Stage 4 Water Conservation in support of WCID 1's construction projects. The planned construction dates were confirmed for May 26-30, and the city has been preparing and publishing public notices for customer notifications. However, the city says its water system has suffered a water main break on one of its main transmission lines prior to the scheduled WCID 1 event. This is compromising the water system's ability to meet customer demand while the line is being repaired. Copperas Cove Mayor Dan D. Yancey issued a Declaration of Local Disaster on Monday morning, in addition to an Order for Stage 4B Implementation. The order is anticipated to be in place through the WCID 1 project completion on May 30. All Copperas Cove citizens are encouraged to review and be familiar with the Stage 4B Restrictions as they are outlined in the document below, or on the city website here. Any person who knowingly or intentionally allows the use of water in violation of the order may be issued a citation for a Class C Misdemeanor, punishable by a fine of $100 to $2,000. If you have any questions or concerns, you can contact: Water Distribution Superintendent Corey Chambers at cchambers@ or (254) 547-2416. Public Relations Specialist Anna Rodriguez at arodriguez@ or (254) 547-4221, Ext. 6704. Code Compliance Supervisor Robert Henning, Jr. at rhenning@ or (254) 542-8966. You can view the documents for the Disaster Declaration and Order for Stage 4B Implementation below. Declaration-of-Local-Disaster-05-26-2025-SignedDownload Order-for-Stage-4B-Implementation-05-26-2025-SignedDownload Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
19-05-2025
- Health
- Yahoo
Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo
Nerandomilast, an investigational agent, met the primary endpoint of both phase III trials, FIBRONEER™-IPF and FIBRONEER™-ILD, significantly reducing the decline in forced vital capacity (FVC) [mL] by absolute change from baseline at week 52, compared to placebo.1,2 Nerandomilast's safety and tolerability profile was consistent across both trials, with similar rates of permanent treatment discontinuation to placebo.1,2 In both trials the composite key secondary endpoint (time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death) was not met. However, in the FIBRONEER™-ILD trial, death occurred in a numerically smaller proportion of patients treated with nerandomilast than placebo.1,2 New drug applications for nerandomilast in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) have been submitted in the US, China and the EU, with other geographies to follow. Boehringer Ingelheim announced today detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD trials. These studies evaluated nerandomilast, an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B), in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), respectively, with and without background antifibrotic therapy. Results were published in the New England Journal of Medicine and also presented as a late-breaking abstract at the American Thoracic Society (ATS) 2025 International Conference. Nerandomilast is an investigational agent and has not been approved for use; its efficacy and safety has not been established. Both trials met the primary endpoint at both doses, 9 mg and 18 mg, as measured by a reduction in the absolute change from baseline in forced vital capacity (FVC) [mL] decline at week 52 versus placebo.1,2 FVC is a measure of lung function.3 "After several challenges in the scientific community to bring forward new clinical data, IPF and PPF continue to take a devastating toll on patients,' said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. 'Having two phase III trials meet the primary endpoint is a major breakthrough for the scientific community, highlighting nerandomilast's potential to have a meaningful impact on patients' unmet needs, being studied as mono therapy or in combination with current treatments.' Across both trials, similar rates of permanent treatment discontinuation to placebo were observed: In FIBRONEER™-IPF, adverse events led to permanent discontinuation of the trial regimen in 14.0% of the nerandomilast 18 mg group, 11.7% of the nerandomilast 9 mg group, and 10.7% of the placebo group.1,2 In FIBRONEER™-ILD, adverse events led to permanent discontinuation of the trial regimen in 10.0% of the nerandomilast 18 mg group, 8.1% in the nerandomilast 9 mg group, and 10.2% in the placebo group.2 In both trials there were no imbalances between the nerandomilast and placebo groups with respect to adverse events of special interest such as vasculitis, depression, suicidality, or drug induced liver injury.1,2 'Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are devastating conditions, with one in two people dying within five years of IPF diagnosis. Despite this stark reality, ongoing research may provide new possibilities for patients, as there remains a need for additional therapies,' said Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim. 'The latest efficacy, safety and tolerability data on nerandomilast points to its potential in addressing the needs of those impacted by IPF and PPF.' FIBRONEER™-IPF (NCT05321069) was a Phase III, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 52 weeks in patients with IPF. A total of 1,177 patients across 36 countries were randomly assigned 1:1:1 to receive nerandomilast 9 mg twice-daily (n=392), nerandomilast 18 mg twice-daily (n=392), or placebo twice-daily (n=393). Randomization was stratified by use of background antifibrotic therapy, with 77.7% receiving nintedanib or pirfenidone at enrollment. Key efficacy results at 52 weeks, as published in the New England Journal of Medicine, include: Placebo Nerandomilast 9 mg twice-daily Nerandomilast 18 mg twice-daily Primary Endpoint (adjusted mean change from baseline in FVC) All patients −183.5 mL (n=391) (95% confidence interval [CI]: -210.9 to -156.1) −138.6 mL (n=390) (95% CI: -165.6 to -111.6) −114.7 mL (n=392) (95% CI: -141.8 to - 87.5) Subgroups of Primary Endpoint (adjusted mean change from baseline in FVC)* *Trial was not powered to show a difference for these subgroups No background antifibrotic therapy −148.7 mL (n=87) −70.4 mL (n=86) −79.2 mL (n=87) Background nintedanib −191.6 mL (n=172) −130.7 mL (n=184) −118.5 mL (n=178) Background pirfenidone −197.0 mL (n=132) −201.8 mL (n=120) −133.7 mL (n=127)The composite key secondary endpoint (time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death) was not met. The most frequent adverse event was diarrhea, reported in 16.0% of the placebo group, 31.1% of the nerandomilast 9 mg group, and 41.3% of the nerandomilast 18 mg group. The adverse event that most frequently led to discontinuation of the trial regimen was diarrhea, with 1.8% in the nerandomilast 9 mg group, 6.1%, in the nerandomilast 18 mg group, and in 0.5% in the placebo group discontinuing treatment. Other adverse events were balanced across treatment groups, specifically showing no imbalances between the nerandomilast and placebo groups in adverse events of special interest such as vasculitis, depression, suicidality, or drug-induced liver injury. Adverse events led to treatment discontinuation more frequently among patients taking background antifibrotic therapy across treatment groups. Serious adverse events occurred in 33%, 31%, and 30% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. Adverse events were fatal in 5%, 4%, and 2% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. FIBRONEER™-ILD (NCT05321082) was a Phase III, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 52 weeks in patients with PPF. A total of 1,176 patients across 44 countries were randomly assigned 1:1:1 to receive nerandomilast 9 mg twice-daily (n=393), nerandomilast 18 mg twice-daily (n=391), or placebo twice-daily (n=392). Randomization was stratified by use of background antifibrotic therapy, with 43.5% receiving nintedanib. Key efficacy results at 52 weeks, as published in the New England Journal of Medicine, include: Placebo Nerandomilast 9 mg twice-daily Nerandomilast 18 mg twice-daily Primary Endpoint (adjusted mean change from baseline in FVC) All patients −165.8 mL (n=391) (95% CI: -190.5 to -141.0) −84.6 mL (n=390) (95% CI: -109.6 to -59.7) −98.6 mL (n=390) (95% CI: -123.7 to -73.4) Subgroups of Primary Endpoint (adjusted mean change from baseline in FVC)* *Trial was not powered to show a difference for these subgroups No background −154.1 mL (n=222) (95% CI: -187.1 to -121.2) −82.3 mL (n=217) (95% CI: -115.9 to -48.8) −95.2 mL (n=220) (95% CI: -128.6 to -61.9) Background nintedanib† −180.9 mL (n=169) (95% CI: -218.6 to -143.2) −87.8 mL (n=173) (95% CI: -125.4 to -50.2) −102.9 mL (n=170) (95% CI: -141.2 to -64.5) †2 patients in this group took pirfenidone rather than nintedanib. These were classified as protocol deviations, but the data from these patients were analyzed as part of the background nintedanib group. Nerandomilast was not statistically significant for the composite key secondary endpoint (time to first acute exacerbation, hospitalization for a respiratory cause, or death), but there were numerically fewer deaths in both treatment groups: 9 mg group (n=33/8.4%), 18 mg group (n=24/6.1%), versus placebo (n=50/12.8%). The safety and tolerability profile of nerandomilast was largely consistent with FIBRONEER™-IPF. The most frequent adverse event was diarrhea, reported in 24.7% of the placebo group, 29.5% of the nerandomilast 9 mg twice daily group, and 36.6% of the nerandomilast 18 mg twice daily group over 52 weeks. There were no imbalances between the nerandomilast and placebo groups in adverse events of special interest such as vasculitis, depression, or suicidality. The adverse events that most frequently led to treatment discontinuation were 'condition aggravated' (i.e., worsening of pulmonary fibrosis) which led to discontinuation in 1.5% in the nerandomilast 9 mg group, 1.0%, in the nerandomilast 18 mg group, and in 3.1% in the placebo group, and diarrhea, which led to discontinuation in 1.3%, 2.6%, and 0.5% of these treatment groups, respectively. The incidence of adverse events that led to treatment discontinuation was generally similar among patients taking background nintedanib therapy and patients not taking background nintedanib therapy. Serious adverse events occurred in 35.2%, 31.8%, and 33.2% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. Adverse events were fatal in 5.1%, 3.6%, and 2.0% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. Nerandomilast (BI 1015550) is an investigational orally administered preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF and PPF.1,2 Nerandomilast was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF in February 2022 and for the treatment of PPF in April 2025. The U.S. FDA recently granted priority review to the New Drug Application (NDA) for nerandomilast in IPF, with an anticipated action date in the fourth quarter of 2025. An NDA for nerandomilast in PPF has also been filed with the FDA. Regulatory submissions for nerandomilast in IPF and PPF are also under review in China and the EU, with filings in other geographies to follow. IPF is one of the more common progressive fibrosing interstitial lung diseases (ILDs).4 In IPF, the root cause of pulmonary fibrosis is not known. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, fatigue and weakness.5 The disease primarily affects patients over the age of 50 and affects more men than women.5 Patients with certain types of non-IPF fibrosing ILD may also develop a progressive phenotype known as PPF. In PPF, there is often a known underlying disease (e.g. rheumatoid arthritis or systemic sclerosis) cause for the ILD.6 In ILDs other than IPF, PPF is defined by worsening respiratory symptoms, physiological evidence of disease progression and radiological evidence of disease progression.6 The prevalence of IPF and PPF varies by region. It is estimated that up to 3.6 million people could be affected by IPF worldwide and up to 5.6 million by PPF.7,8 Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at (UK) or (rest of world). 1Richeldi L, et al. (2025) Nerandomilast in patients with idiopathic pulmonary fibrosis. In: NEJM. 2025. 2Maher TM, et al. (2025) Nerandomilast in patients with progressive pulmonary fibrosis. In: NEJM. 2025. 3Twisk JWR et al. (1998). Tracking of lung function parameters and the longitudinal relationship with lifestyle. European Respiratory Journal. 12(3):627–634. 4Sauleda J, et al. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Basel). 2018 Nov 29;6(4):110. doi: 10.3390/medsci6040110. PMID: 30501130; PMCID: PMC6313500. 5European Lung Foundation (2023) IPF - Idiopathic Pulmonary Fibrosis. Accessed April 2025. Available at: 6Podolanczuk AJ, Fernández Peréz ER. Identification, course, and management of progressive pulmonary fibrosis. Am J Manag Care. 2024 Oct;30(7 Suppl):S122-S130. doi: 10.37765/ajmc.2024.89634. PMID: 39495032. 7Maher TM, Bendstrup E, Dron L, Langley J, Smith G, Khalid JM, Patel H, Kreuter M. Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res. 2021 Jul 7;22(1):197. doi: 10.1186/s12931-021-01791-z. PMID: 34233665; PMCID: PMC8261998. 8Cottin V, Teague R, Nicholson L, Langham S, Baldwin M. The Burden of Progressive-Fibrosing Interstitial Lung Diseases. Front Med (Lausanne). 2022 Feb 1;9:799912. Doi: 10.3389/fmed.2022.799912. PMID: 35178411; PMCID: PMC8843847. Assuming a world population of 8bn
Yahoo
19-05-2025
- Health
- Yahoo
Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo
Nerandomilast, an investigational agent, met the primary endpoint of both phase III trials, FIBRONEER™-IPF and FIBRONEER™-ILD, significantly reducing the decline in forced vital capacity (FVC) [mL] by absolute change from baseline at week 52, compared to placebo.1,2 Nerandomilast's safety and tolerability profile was consistent across both trials, with similar rates of permanent treatment discontinuation to placebo.1,2 In both trials the composite key secondary endpoint (time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death) was not met. However, in the FIBRONEER™-ILD trial, death occurred in a numerically smaller proportion of patients treated with nerandomilast than placebo.1,2 New drug applications for nerandomilast in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) have been submitted in the US, China and the EU, with other geographies to follow. Boehringer Ingelheim announced today detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD trials. These studies evaluated nerandomilast, an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B), in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), respectively, with and without background antifibrotic therapy. Results were published in the New England Journal of Medicine and also presented as a late-breaking abstract at the American Thoracic Society (ATS) 2025 International Conference. Nerandomilast is an investigational agent and has not been approved for use; its efficacy and safety has not been established. Both trials met the primary endpoint at both doses, 9 mg and 18 mg, as measured by a reduction in the absolute change from baseline in forced vital capacity (FVC) [mL] decline at week 52 versus placebo.1,2 FVC is a measure of lung function.3 "After several challenges in the scientific community to bring forward new clinical data, IPF and PPF continue to take a devastating toll on patients,' said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. 'Having two phase III trials meet the primary endpoint is a major breakthrough for the scientific community, highlighting nerandomilast's potential to have a meaningful impact on patients' unmet needs, being studied as mono therapy or in combination with current treatments.' Across both trials, similar rates of permanent treatment discontinuation to placebo were observed: In FIBRONEER™-IPF, adverse events led to permanent discontinuation of the trial regimen in 14.0% of the nerandomilast 18 mg group, 11.7% of the nerandomilast 9 mg group, and 10.7% of the placebo group.1,2 In FIBRONEER™-ILD, adverse events led to permanent discontinuation of the trial regimen in 10.0% of the nerandomilast 18 mg group, 8.1% in the nerandomilast 9 mg group, and 10.2% in the placebo group.2 In both trials there were no imbalances between the nerandomilast and placebo groups with respect to adverse events of special interest such as vasculitis, depression, suicidality, or drug induced liver injury.1,2 'Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are devastating conditions, with one in two people dying within five years of IPF diagnosis. Despite this stark reality, ongoing research may provide new possibilities for patients, as there remains a need for additional therapies,' said Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim. 'The latest efficacy, safety and tolerability data on nerandomilast points to its potential in addressing the needs of those impacted by IPF and PPF.' FIBRONEER™-IPF (NCT05321069) was a Phase III, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 52 weeks in patients with IPF. A total of 1,177 patients across 36 countries were randomly assigned 1:1:1 to receive nerandomilast 9 mg twice-daily (n=392), nerandomilast 18 mg twice-daily (n=392), or placebo twice-daily (n=393). Randomization was stratified by use of background antifibrotic therapy, with 77.7% receiving nintedanib or pirfenidone at enrollment. Key efficacy results at 52 weeks, as published in the New England Journal of Medicine, include: Placebo Nerandomilast 9 mg twice-daily Nerandomilast 18 mg twice-daily Primary Endpoint (adjusted mean change from baseline in FVC) All patients −183.5 mL (n=391) (95% confidence interval [CI]: -210.9 to -156.1) −138.6 mL (n=390) (95% CI: -165.6 to -111.6) −114.7 mL (n=392) (95% CI: -141.8 to - 87.5) Subgroups of Primary Endpoint (adjusted mean change from baseline in FVC)* *Trial was not powered to show a difference for these subgroups No background antifibrotic therapy −148.7 mL (n=87) −70.4 mL (n=86) −79.2 mL (n=87) Background nintedanib −191.6 mL (n=172) −130.7 mL (n=184) −118.5 mL (n=178) Background pirfenidone −197.0 mL (n=132) −201.8 mL (n=120) −133.7 mL (n=127)The composite key secondary endpoint (time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death) was not met. The most frequent adverse event was diarrhea, reported in 16.0% of the placebo group, 31.1% of the nerandomilast 9 mg group, and 41.3% of the nerandomilast 18 mg group. The adverse event that most frequently led to discontinuation of the trial regimen was diarrhea, with 1.8% in the nerandomilast 9 mg group, 6.1%, in the nerandomilast 18 mg group, and in 0.5% in the placebo group discontinuing treatment. Other adverse events were balanced across treatment groups, specifically showing no imbalances between the nerandomilast and placebo groups in adverse events of special interest such as vasculitis, depression, suicidality, or drug-induced liver injury. Adverse events led to treatment discontinuation more frequently among patients taking background antifibrotic therapy across treatment groups. Serious adverse events occurred in 33%, 31%, and 30% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. Adverse events were fatal in 5%, 4%, and 2% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. FIBRONEER™-ILD (NCT05321082) was a Phase III, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 52 weeks in patients with PPF. A total of 1,176 patients across 44 countries were randomly assigned 1:1:1 to receive nerandomilast 9 mg twice-daily (n=393), nerandomilast 18 mg twice-daily (n=391), or placebo twice-daily (n=392). Randomization was stratified by use of background antifibrotic therapy, with 43.5% receiving nintedanib. Key efficacy results at 52 weeks, as published in the New England Journal of Medicine, include: Placebo Nerandomilast 9 mg twice-daily Nerandomilast 18 mg twice-daily Primary Endpoint (adjusted mean change from baseline in FVC) All patients −165.8 mL (n=391) (95% CI: -190.5 to -141.0) −84.6 mL (n=390) (95% CI: -109.6 to -59.7) −98.6 mL (n=390) (95% CI: -123.7 to -73.4) Subgroups of Primary Endpoint (adjusted mean change from baseline in FVC)* *Trial was not powered to show a difference for these subgroups No background −154.1 mL (n=222) (95% CI: -187.1 to -121.2) −82.3 mL (n=217) (95% CI: -115.9 to -48.8) −95.2 mL (n=220) (95% CI: -128.6 to -61.9) Background nintedanib† −180.9 mL (n=169) (95% CI: -218.6 to -143.2) −87.8 mL (n=173) (95% CI: -125.4 to -50.2) −102.9 mL (n=170) (95% CI: -141.2 to -64.5) †2 patients in this group took pirfenidone rather than nintedanib. These were classified as protocol deviations, but the data from these patients were analyzed as part of the background nintedanib group. Nerandomilast was not statistically significant for the composite key secondary endpoint (time to first acute exacerbation, hospitalization for a respiratory cause, or death), but there were numerically fewer deaths in both treatment groups: 9 mg group (n=33/8.4%), 18 mg group (n=24/6.1%), versus placebo (n=50/12.8%). The safety and tolerability profile of nerandomilast was largely consistent with FIBRONEER™-IPF. The most frequent adverse event was diarrhea, reported in 24.7% of the placebo group, 29.5% of the nerandomilast 9 mg twice daily group, and 36.6% of the nerandomilast 18 mg twice daily group over 52 weeks. There were no imbalances between the nerandomilast and placebo groups in adverse events of special interest such as vasculitis, depression, or suicidality. The adverse events that most frequently led to treatment discontinuation were 'condition aggravated' (i.e., worsening of pulmonary fibrosis) which led to discontinuation in 1.5% in the nerandomilast 9 mg group, 1.0%, in the nerandomilast 18 mg group, and in 3.1% in the placebo group, and diarrhea, which led to discontinuation in 1.3%, 2.6%, and 0.5% of these treatment groups, respectively. The incidence of adverse events that led to treatment discontinuation was generally similar among patients taking background nintedanib therapy and patients not taking background nintedanib therapy. Serious adverse events occurred in 35.2%, 31.8%, and 33.2% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. Adverse events were fatal in 5.1%, 3.6%, and 2.0% of patients treated with placebo, nerandomilast 9 mg, and nerandomilast 18 mg, respectively. Nerandomilast (BI 1015550) is an investigational orally administered preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF and PPF.1,2 Nerandomilast was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF in February 2022 and for the treatment of PPF in April 2025. The U.S. FDA recently granted priority review to the New Drug Application (NDA) for nerandomilast in IPF, with an anticipated action date in the fourth quarter of 2025. An NDA for nerandomilast in PPF has also been filed with the FDA. Regulatory submissions for nerandomilast in IPF and PPF are also under review in China and the EU, with filings in other geographies to follow. IPF is one of the more common progressive fibrosing interstitial lung diseases (ILDs).4 In IPF, the root cause of pulmonary fibrosis is not known. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, fatigue and weakness.5 The disease primarily affects patients over the age of 50 and affects more men than women.5 Patients with certain types of non-IPF fibrosing ILD may also develop a progressive phenotype known as PPF. In PPF, there is often a known underlying disease (e.g. rheumatoid arthritis or systemic sclerosis) cause for the ILD.6 In ILDs other than IPF, PPF is defined by worsening respiratory symptoms, physiological evidence of disease progression and radiological evidence of disease progression.6 The prevalence of IPF and PPF varies by region. It is estimated that up to 3.6 million people could be affected by IPF worldwide and up to 5.6 million by PPF.7,8 Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at (UK) or (rest of world). 1Richeldi L, et al. (2025) Nerandomilast in patients with idiopathic pulmonary fibrosis. In: NEJM. 2025. 2Maher TM, et al. (2025) Nerandomilast in patients with progressive pulmonary fibrosis. In: NEJM. 2025. 3Twisk JWR et al. (1998). Tracking of lung function parameters and the longitudinal relationship with lifestyle. European Respiratory Journal. 12(3):627–634. 4Sauleda J, et al. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Basel). 2018 Nov 29;6(4):110. doi: 10.3390/medsci6040110. PMID: 30501130; PMCID: PMC6313500. 5European Lung Foundation (2023) IPF - Idiopathic Pulmonary Fibrosis. Accessed April 2025. Available at: 6Podolanczuk AJ, Fernández Peréz ER. Identification, course, and management of progressive pulmonary fibrosis. Am J Manag Care. 2024 Oct;30(7 Suppl):S122-S130. doi: 10.37765/ajmc.2024.89634. PMID: 39495032. 7Maher TM, Bendstrup E, Dron L, Langley J, Smith G, Khalid JM, Patel H, Kreuter M. Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res. 2021 Jul 7;22(1):197. doi: 10.1186/s12931-021-01791-z. PMID: 34233665; PMCID: PMC8261998. 8Cottin V, Teague R, Nicholson L, Langham S, Baldwin M. The Burden of Progressive-Fibrosing Interstitial Lung Diseases. Front Med (Lausanne). 2022 Feb 1;9:799912. Doi: 10.3389/fmed.2022.799912. PMID: 35178411; PMCID: PMC8843847. Assuming a world population of 8bn
Buzz Feed
01-05-2025
- Politics
- Buzz Feed
'Please Don't Get Married' — This Woman Is Going Viral For Explaining Why Women Should Not Get Married
From attacks on reproductive rights to a rise in young men moving to the alt-right, I can't help but feel uneasy for women right now. If you've kept up with online chatter or are deep in the conversations yourself, you might be in tune with the growing political divide between men and women. Last year, researchers found that globally, women are growing more progressive and young men are moving more conservative. In response, movements like South Korea's 4B movement — where women reject marriage, dating, sex, and childbearing with men altogether — have gained traction. I mean, I can't blame them. As "the broligarchy" takes hold and actively fosters a culture where men think the likes of Andrew Tate are OK, this is the kind of conversation that's popping up on my timeline as of late. Dark stuff, indeed. At the same time, there's a rise in influencers promoting "soft life" aesthetics and "trad-wife" ideals that embrace traditional, domestic gender roles, where the women are often seen cooking, caring for babies, having expensive, carefully curated homes and clothes, and generally not working outside of the house. One voice cutting through the noise is MJ, known as @texasfairygarden on TikTok. In a viral video that over 1.5 million people have seen, she delivered a searing message: "Please don't get married." In her video, MJ pleaded with women not to get married, not out of cynicism, but out of a historical and social understanding of what marriage has traditionally meant for women: "Marriage was the act of making women property. Marriage was the way of exchanging women as property. Marriage was the property transfer of a woman between her father and her husband, regardless of how you feel about it," she said. MJ argued that the drop in birth and marriage rates, which conservatives often frame as a crisis, is actually a sign of progress: women are making choices for themselves. "The reason why you're seeing marriage rates and birth rates decline is because, for the first time in human history, women have had more agency than we've ever had on whether or not we get married, married in the first place, and whether or not we decide to have children," she said. "There is a reason why women have been socially conditioned into believing that if we don't have children, or if we're not married, or a man didn't choose us, that's, like, the biggest insult to our identity or our value as human beings," MJ continued, nodding to the fact that patriarchal norms instill fear that women are not worthy or not wanted without marriage or children. "I personally disagree with the entire construct of marriage. I believe that marriage signifies the ownership of women, and I disagree with it as a concept, as a whole," she said. MJ explained that she has no intention of getting married or having kids. And she doesn't see that as a loss, but as liberation. "I relish in the idea of being single. I do not want to have any children. And I relish in the idea that for the first time, I'm one of the first generations of women who have the freedom to not participate in any of those things," she explained. "So to me, not only is it not an insult to my identity and does not dictate my worthiness as a human being, it is a privilege that I get to choose not to get married. It is a privilege that I get to choose not to have children." MJ made it clear that she thinks that, generally, women should avoid getting married and having children as a default. "I think if you are even remotely on the fence about any of those concepts, you need to avoid it. Marriage benefits men, and having children benefits the patriarchy," she said. MJ acknowledged that there are, of course, there are nuances. "I'm not saying that no one should have children. Or that's where it gets kind of, like, muddy," she said. "I think that marriage does have protections for women who do wanna have children or for women who are with a partner who's great. There are legal protections around that that marriage works in favor of." Still, generally, she thinks marriage should be avoided. Speaking with BuzzFeed, she said, "Marriage is a contract that makes sharing a life with someone easier to navigate when it comes to financial, legal, and parental dealings. But it's just that: a business contract. It's not a declaration of love, but a legal protection for involved parties, and should be approached as such." Some people in the comments similarly agreed: "Marriage is a huge deal, and especially as a woman, if you are at all on the fence about getting married, you need to not get married," MJ continued in her video. MJ also called out "soft life" content that sometimes glamorizes financial dependence on men. "Fuck the 'soft life' shit. Fuck the not doing anything with your life. Fuck not making your own money. You need to make your own money. That is a privilege. That is a blessing that you live in a time where you can make your own money and you can make something out of your own life," she said. "Do not trade this privilege that women have fought for for a G-Wagon or for trips to Erewhon. You are worth so much more than that. Your life is worth so much more than that," she continued. "If you marry a rich man, your life will be controlled by him. Your quality of life is going to be dictated by that man," she warned. "[The] relationship may look a certain way today, but it could be very different 10 years from now. It could be very different after you have four of his children. It's not worth the Chanel bags. It's not worth the Cartier bracelets. It's not worth the fancy vacations. This is your one life. This is your independence. This is your autonomy." "Please just think very long and hard before you enter these contracts. Because the getting out of marriage, going through a divorce, is a fucking grueling process. Co-parenting with somebody who is being difficult, who is trying to control you, is an all-consuming process. You need to really understand what you're signing up for when you do that. This is not something that you do unless you are absolutely sure," she continued. "...Do not put all your eggs in the basket of a man. Cause once you get married and once you have those children, everything is different. You do not have that same freedom anymore. You will not have that same opportunity anymore. You can still make it happen." "Being single and childless is a fucking flex, okay? It is," MJ ended. "It's much better than being in a grueling divorce, being in an unhappy marriage, being controlled by a man, or having to co-parent with someone who's fucking crazy. Please, just take this seriously? Okay?" Many child-free, single, and formerly married women also validated MJ's stance. "I'm 58 and childfree. Never regretted it once. NOT. ONCE. I regret BOTH marriages," someone wrote. @texasgardenfairy / Via Even married women and people with children agreed with overwhelming support. "As a HAPPILY married woman I can STILL say... you're not wrong," one person said. "I'm married (actually love my marriage) but I agree with you. It's actually dangerous unless the person is your best friend, you want to live the same life, they don't make you have kids, and generous. Otherwise don't," another wrote. @texasgardenfairy / Via Considering the current political climate, where we have a president who bragged about helping overturn Roe v. Wade, was held liable for sexual abuse, amongst other rollbacks directly affecting decades of progress in women's equality and bodily autonomy, MJ's message feels particularly urgent. Mark Wilson / Getty Images "We no longer have the luxury of neglecting introspection of our long-held norms as a society," MJ told BuzzFeed. She emphasized that women must reevaluate what truly serves their best interests regarding marriage and motherhood, because the freedoms we've come to rely on are not guaranteed. "Christian nationalism is making shocking progress towards becoming a mainstream belief due to unregulated social media algorithms. Women need to acknowledge the power and advantages we do have and act accordingly before it's too late," she told BuzzFeed. Anna Moneymaker / Getty Images MJ clarified that her stance is not to shame anyone, but instead to provide a different perspective on common narratives. She said, "I'm very fortunate that people have been able to receive this video with the understanding and nuance it requires. This was never a personal attack on anyone who wants to or chooses to get married." "I just wanted to offer a perspective from someone who sees it differently, and I want to reassure women that it's okay: you're not crazy. If you're unsure about marriage, you're making the right choice by not getting married. That is not and should not be how you determine your value as a human being." Well, whether you agree with MJ or not, her perspective reminds us that marriage and motherhood are choices, not obligations. And in a world where politicians demand more children while stripping away the resources to raise them, maybe it's time we ask: What would society look like if marriage and motherhood weren't romanticized as the ultimate goal? Let us know your thoughts down in the comments.
