Latest news with #ASPEN
The National
22-06-2025
- Politics
- The National
Inside an asylum hotel – the experiences of those left waiting
The so-called 'asylum hotels' have been the site of anti-immigration protests in recent years, and hit the headlines last summer when they became the target of far-right riots in England, but so often missing from the coverage are the voices of those living inside. The Sunday National met three men staying in a hotel to find out more about their experience in Scotland. Kawa KAWA* has been in asylum accommodation for 10 months, first in Aberdeen and then more recently in South Lanarkshire. In his home country of Iran, speaking out against the regime's human rights abuses can have grave consequences. When his activities were reported to the authorities, he was forced to flee his home in the middle of the night to avoid capture. 'There were no preparations, it happened all of a sudden,' Kawa said. 'I was just thinking about not falling into the hands of the government because they easily burn lives. If I was arrested, a dark fate awaited me.' He paid a smuggler for safe passage from Iran into Europe – a dangerous journey he 'would not even wish on his enemies'. The 35-year-old wears a black cap every day, which he explained was to cover his newly greying hair. READ MORE: BBC officially axes documentary on Gaza doctors over 'impartiality' concerns 'During this time all my hair turned white … being away from my family cost me a lot. Now I hide myself when I talk to them so they won't be upset.' Kawa left behind his wife in Tehran and has been suffering from depression since he arrived in Scotland. Unable to speak English, he explained through a translator that he has struggled to get the support he needs for his mental health. Furthermore, issues with his ASPEN card – a prepaid card which allows people seeking asylum to get their weekly subsistence allowance – means he has yet to receive any financial support. While their claim for refugee status is assessed, people seeking asylum are not allowed to work or claim benefits. The hotel provides a room and three basic meals a day, and the Government issues a weekly allowance of £8.86. With no income and nothing to do all day, frustration and boredom set in quickly with residents, many of whom face lengthy waits for their applications to be processed. Mohammad MOHAMMAD* stayed in the hotel for 15 months. He left Sudan on the back of a sheep lorry, the only means of transport he could find, to escape war in 2023. 'There's nothing to plan for with nine pounds,' said Mohammad. 'You just sleep, get up, sleep – there's a lot of time to think. The time in the hotel is very difficult for mental health, with anxiety and depression. 'If allowed to study during asylum time it would be very helpful. Instead of letting people stay and waiting, let them work and do something to support themselves and the community.' People like Kawa and Mohammad rely on charities to provide clothes and other basic amenities. With a long history of accommodating asylum seekers, Glasgow has many organisations that provide support, but even a trip into the city is often out of reach for those accommodated in other towns across Scotland. 'When I arrived, there were no organisations in this area,' Mohammad said. 'People were talking about stopping asylum and sending people to Rwanda; I was scared about this. 'Maybe because there is a lot of fake news about people coming here, inside you feel strange; it's a big barrier most people are struggling with. You don't feel it's your real country. We are very thankful for everything, but there's still this kind of sense.' Dismayed by the lack of services in South Lanarkshire, a group of local residents formed East Kilbride Integration Network (EKin) at the end of 2023 to help address the basic needs of those in the hotel. They hold monthly conversation cafes, where people can meet for a hot drink, practise their English and even get a haircut. Mohammad took up the opportunity to attend English classes and play football with a local team. He has since started volunteering at the organisation, alongside fellow refugee Ahmed* who also fled the war in Sudan. Ahmed AHMED travelled to the UK alone, in a journey across North Africa and into Europe that spanned five months. A huge football fan, he said his knowledge of England was mostly from supporting Liverpool FC, but the 25-year-old knew nothing of Scotland before he was placed here. 'When I came here, I was really nervous,' he said. 'I'm in a different country with new people – are they going to be friendly with us or not? I asked myself many questions. I didn't go out in my first three weeks.' READ MORE: Labour blasted as 'deeply authoritarian' over plans to proscribe Palestine Action Ahmed was unable to speak English when he arrived in 2023, and 'felt ashamed' that he could not converse with people due to the language barrier. Armed with a notepad and pen, he spent his time in the library with the aim of learning 10 new words every day. He added: 'I have to learn quickly to understand people and the system, or there are so many doors closed on your face in the future.' The asylum system not only dictates where you live while you await the outcome of your application, but it also strips away the daily autonomy most take for granted – such as what food to eat and when. 'Sometimes the food is bad, sometimes it's nice,' Ahmed said. 'You don't have any choice, you have to eat at the same time, if you didn't eat at that time, there is no food for you.' With no friends or family around, everyone we spoke to told us life in the asylum system can be very isolating. More than 100 refugee charities across the UK recently signed an open letter urging the UK Government to end the use of hotels and instead accommodate people in community housing which supports 'better integration into society'. In the current circumstances, local organisations that offer events and support are often the only way for people to make new connections in the area. 'In EKin community I made friends, they help us so much,' said Ahmed. 'There are a lot of activities, I play football, sometimes the gym, and badminton – I didn't have any idea about this. Last year we went on some trips to Edinburgh, to Kelvingrove Museum, it was fantastic. I feel like I'm in the middle of my family.' Mohammad and Ahmed recently received their refugee status, and are planning to further their education in software development and electrical engineering respectively. They both want to remain in Scotland to build their new lives. Kawa's initial asylum claim was rejected by the Home Office, and now he is awaiting the outcome of his appeal. *Names have been changed
&w=3840&q=100)
Business Standard
09-06-2025
- Business
- Business Standard
Glenmark set to launch blood cancer treatment drug Brukinsa in India
Glenmark Pharmaceuticals Ltd, a global pharmaceutical company, is set to introduce zanubrutinib in India under the brand name Brukinsa, following approval from the Drugs Controller General of India (DCGI). Brukinsa, developed by global oncology company BeOne Medicines (formerly BeiGene), is an orally available Bruton's tyrosine kinase (BTK) inhibitor designed to treat multiple types of B-cell blood cancers. It is the first and only BTK inhibitor approved in India for five types of B-cell malignancies. Approved in over 70 countries Brukinsa has already been approved in more than 70 countries, with clinical efficacy demonstrated through trials such as ALPINE, ASPEN and SEQUOIA. Its entry into the Indian market addresses a critical need for new and effective blood cancer treatments. The drug offers a unique pharmacological profile with high response rates and durable disease control across multiple B-cell malignancies. It allows a flexible dosing schedule—once or twice daily—tailored to patient needs. In the ALPINE trial for relapsed or refractory chronic lymphocytic leukaemia (CLL), Brukinsa showed a lower incidence of serious cardiac side effects compared to ibrutinib, a widely used targeted therapy. Fewer patients discontinued Brukinsa due to heart-related complications. "We look forward to bringing Brukinsa to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines)," said Alok Malik, President and Business Head – India Formulations, Glenmark Pharmaceuticals. 'This launch marks a significant milestone in our innovative oncology portfolio, offering patients in India access to a globally trusted therapy with proven efficacy and safety. It underscores Glenmark's ongoing commitment to providing effective and advanced treatments for patients with haematological malignancies," he added. Global partnership expands to India Adam Roach, Senior Vice President and Head of the Japan and Asia Pacific region at BeiGene, commented: 'The introduction of Brukinsa in India marks an important step in our ongoing mission to expand patient access to innovative oncology treatments across the Asia Pacific region.' 'We are proud to support Glenmark in bringing this therapy to patients in India, furthering our shared commitment to improve healthcare outcomes globally,' he said.
Business Standard
09-06-2025
- Health
- Business Standard
Glenmark receives DCGI approval to launch oncology drug BRUKINSA in India
Glenmark Pharmaceuticals has announced the upcoming launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). Zanubrutinib will be marketed in India under the brand name BRUKINSA, an innovative therapy developed by BeiGene (now BeOne Medicines), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. BRUKINSA is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved in India for the treatment of five distinct B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenstr macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). Globally, BRUKINSA is approved in more than 70 countries, supported by compelling clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA. This extensive clinical program underscores BRUKINSA's proven efficacy, strong safety profile, and broad therapeutic value. The introduction of BRUKINSA brings an innovative treatment option at a time when India continues to face a significant burden from serious and difficult-to-treat haematological malignancies. According to various sources, someone in India is diagnosed with blood cancer every five minutes, and an estimated 70,000 people die from the disease each year. BRUKINSA addresses a critical unmet need with its differentiated pharmacological profile, demonstrating high response rates and durable disease control across multiple B-cell malignancies as shown in pivotal clinical trials. BRUKINSA's flexible dosing regimen (once or twice daily) supports personalized care.1 In the head-to-head ALPINE study in relapsed/refractory chronic lymphocytic leukemia, BRUKINSA demonstrated a lower rate of serious cardiac events (1.9% vs. 7.7%) and fewer treatment discontinuations due to cardiac issues (0.3% vs. 4.3%) compared with ibrutinib.
Business Upturn
09-06-2025
- Business
- Business Upturn
Glenmark Pharmaceuticals to launch Zanubrutinib (BRUKINSA) in India after DCGI approval
Glenmark Pharmaceuticals has announced the launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). The drug will be marketed under the brand name BRUKINSA®, developed by BeiGene (now BeOne Medicines), a global oncology company. This marks the introduction of the first Bruton's tyrosine kinase (BTK) inhibitor in India approved for the treatment of five B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). BRUKINSA is approved in over 70 countries, backed by data from clinical studies such as ALPINE, ASPEN, and SEQUOIA. These trials have demonstrated consistent clinical outcomes across various B-cell cancers. The availability of BRUKINSA in India comes at a time when blood cancers continue to impact a large number of individuals. Estimates suggest that someone is diagnosed with blood cancer every five minutes in India, with annual deaths from the disease numbering around 70,000. The treatment has shown high response rates and the ability to maintain disease control in patients with different types of B-cell malignancies. It also offers dosing flexibility, allowing for once or twice-daily administration. In the ALPINE study, BRUKINSA was compared with ibrutinib in relapsed or refractory CLL and showed a lower rate of serious cardiac events and fewer treatment discontinuations due to cardiac-related issues. With its recent regulatory approval, BRUKINSA will now be available to patients in India who are affected by challenging hematological cancers. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Malaysian Reserve
24-04-2025
- Health
- Malaysian Reserve
New England Journal of Medicine Publishes Positive Results from Insmed's Pivotal Phase 3 ASPEN Study of Brensocatib in Patients with Bronchiectasis
—Largest Global Clinical Trial Ever Conducted in Bronchiectasis Demonstrates Statistically Significant and Clinically Meaningful Reduction in Frequency of Pulmonary Exacerbations Versus Placebo— —Brensocatib 25 mg is the First Investigational Therapy for Bronchiectasis to Show a Statistically Significant Reduction in the Rate of Lung Function Decline— —Brensocatib is Currently Under Priority Review with the U.S. Food and Drug Administration— BRIDGEWATER, N.J., April 23, 2025 /PRNewswire/ — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that positive results from the pivotal phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis were published in the New England Journal of Medicine (NEJM). The landmark ASPEN study is the largest clinical trial ever conducted in bronchiectasis, a serious, chronic, and progressive inflammatory pulmonary disease that today has no approved therapies. 'Bronchiectasis is a debilitating disease characterized by pulmonary exacerbations, which contribute to lung function decline and severely impact quality of life,' said lead author James Chalmers, MBChB, PhD, Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. 'With limited treatment options and no approved therapies, the burden of exacerbations remains high, with many patients experiencing multiple episodes each year. For the first time, the ASPEN data published in NEJM demonstrates that a treatment which targets inflammation can reduce exacerbations and slow the rate of lung function decline. This is an exciting development and represents a potentially transformative breakthrough for people living with bronchiectasis, offering new hope for patients with this challenging condition if brensocatib is approved.' As previously reported, the ASPEN study met its primary endpoint, with both brensocatib doses achieving statistical and clinical significance for the reduction in the annualized rate of pulmonary exacerbations versus placebo over the 52-week treatment period. The annualized rate of exacerbations was 1.02 for brensocatib 10 mg, 1.04 for brensocatib 25 mg, and 1.29 for placebo. These rates were significantly lower in the brensocatib 10 mg and 25 mg groups versus placebo with rate ratios of 0.79 (adjusted P=0.004) and 0.81 (adjusted P=0.005), respectively. Both dosage strengths of brensocatib also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients treated with brensocatib 25 mg also showed significantly lower lung function decline at week 52 as measured by post-bronchodilator forced expiratory volume over one second (FEV1). Brensocatib was well-tolerated in the study. Treatment-emergent adverse events (TEAEs) occurring in at least 5.0% of patients treated with either dose of brensocatib and more frequently than in placebo were COVID-19 (15.8%, 20.9%, 15.8%), nasopharyngitis (7.7%, 6.3%, 7.6%), cough (7.0%, 6.1%, 6.4%), and headache (6.7%, 8.5%, and 6.9%) for brensocatib 10 mg, brensocatib 25 mg, and placebo, respectively. 'Currently, people with bronchiectasis have no approved treatments to address the frequent, damaging exacerbations that are the hallmark of this disease,' said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. 'Brensocatib has the potential to be the first approved therapy to fill this critical unmet need in the care of patients with bronchiectasis, as well as the first approved dipeptidyl peptidase 1 (DPP1) inhibitor—a new mechanism of action with the potential to address a range of neutrophil-mediated inflammatory diseases. The ASPEN trial represents a transformative step forward for the millions of people globally diagnosed with bronchiectasis.' Brensocatib is currently under Priority Review with the U.S. Food and Drug Administration, with a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA). About ASPEN The total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. About Bronchiectasis Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Today, approximately 500,000 patients in the U.S., 600,000 patients in the EU5 (France, Germany, Italy, Spain, and UK), and 150,000 patients in Japan have been diagnosed with bronchiectasis, and there are currently no approved therapies specifically targeting bronchiectasis in these regions. About Brensocatib Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction. About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending four consecutive years as the No. 1 Science Top Employer. Visit to learn more. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. 'Forward-looking statements,' as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as 'may,' 'will,' 'should,' 'could,' 'would,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'predicts,' 'intends,' 'potential,' 'continues,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for brensocatib in the U.S., Europe or Japan; failure to successfully commercialize brensocatib, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, if approved; uncertainties in the degree of market acceptance of brensocatib, if approved, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for brensocatib, if approved, or acceptable prices for brensocatib, if approved; inaccuracies in our estimates of the size of the potential markets for brensocatib or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of brensocatib, if approved; development of unexpected safety or efficacy concerns related to brensocatib; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; the risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; restrictions or other obligations imposed on us by agreements related to brensocatib, including our license agreement with AstraZeneca AB, and failure to comply with our obligations under such agreements; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; and inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, 'Risk Factors,' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan DunnVice President, Investor Relations(646) 812-4030 Media: Claire MulhearnVice President, Corporate Communications(862) 842-6819media@
