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FACILITY CALENDARSopen gym, field, track, aerobics studio, and lane swim timesTrong thời buổi kinh tế thị trường hiện nay thì môi trường chính là vấn đề nóng bỏng được chính phủ các quốc gia quan tâm hàng đầu, trong đó có Việt Nam. Song song với quá trình phát triển công nghệ hiện đại thì chất thải đang dần trở thành mối nguy hại đối với đời sống và sức khỏe con người. Theo thống kê của Tổ chức Y tế Thế giới (WHO) thì có đến 92% dân số hiện đang sống trong bầu không khí bị ô nhiễm. Mà bụi, khí thải là những thứ mà có thể nhìn rõ bằng mắt thường qua những thay đổi thường ngày. Nguyên do chính dẫn đến tình trạng này lại chủ yếu đến từ hoạt động kinh doanh sản xuất và sinh hoạt của con người. Chính vì thế, để có được một môi trường xanh, sạch, đẹp thì cần phải có những giải pháp tối ưu và hiệu quả nhất. Nhận thấy được vấn đề này, Chính phủ đã đưa ra các quy định cụ thể về việc quản lý bụi, khí thải để kiểm soát, bảo vệ môi trường một cách hệ thống nhất. Trong phạm vi bài viết này, Luật Hoàng Anh sẽ làm rõ các yêu cầu về quản lý và kiểm soát bụi, khí thải theo Điều 88 Luật bảo vệ môi trường số 72/2020/QH14 ngày 17 tháng 11 năm 2020 (sau đây được gọi là Luật Bảo vệ môi trường năm 2020). Nội dung này được quy định cụ thể tại khoản 1 Điều 88 Luật Bảo vệ môi trường năm 2020. Theo đó, pháp luật quy định tổ chức, cá nhân hoạt động sản xuất, kinh doanh, dịch vụ có phát tán bụi, khí thải phải kiểm soát và xử lý bụi, khí thải bảo đảm quy chuẩn kỹ thuật môi trường. Bụi có yếu tố nguy hại vượt ngưỡng quy định phải được quản lý theo quy định của pháp luật về quản lý chất thải nguy hại. Khí thải là các thành phần vật chất độc hại dạng khí hoặc hơi được thải ra từ những hoạt động sản xuất công nghiệp và sinh hoạt hàng ngày của con người. Hiểu một cách đơn giản thì khí thải được phát sinh từ sự đốt cháy các nhiên liệu khí tự nhiên, xăng, dầu, hỗn hợp, than đá, nhiên liệu diesel. Trong khi đó, bụi là những hạt vật chất nhỏ tồn tại cả ở dạng rắn, lỏng, khí bay lơ lửng trong không khí và chúng có mặt ở tất cả mọi nơi ngay cả trong nhà hay ngoài trời. Chúng chứa rất nhiều độc tố và có thể gây ảnh hưởng đến sức khỏe con người và môi trường sống xung quanh. Vì vậy, việc kiểm soát bụi và khí thải là nhiệm vụ rất quan trọng của mọi tổ chức cá nhân làm phát sinh bụi, khí thải và việc thực hiện phải đảm bảo quy chuẩn kỹ thuật môi trường. Căn cứ khoản 2 Điều 88 Luật Bảo vệ môi trường năm 2020 quy định như sau:
Quy chuẩn kỹ thuật môi trường là mức giới hạn của các thông số về chất lượng môi trường xung quanh, hàm lượng của các chất gây ô nhiễm có trong chất thải, các yêu cầu kỹ thuật và quản lý được cơ quan nhà nước có thẩm quyền ban hành dưới dạng văn bản bắt buộc áp dụng để bảo vệ môi trường. Bụi và khí thải có mặt ở khắp mọi nơi, tuy nhiên, các phương tiện giao thông, máy móc, thiết bị, công trình là nơi phát sinh ra chủ yếu lượng bụi, khí thải với khối lượng lớn bởi độ bao phủ và tần suất sử dụng thường xuyên. Do đó, việc thiết lập bộ phận lọc, giảm thiểu khí thải hay thiết bị che chắn là việc rất cần thiết góp phẩn hạn chế việc xả thải bụi, khí thải tự do ra ngoài môi trường. Khoản 3 Điều 88 Luật Bảo vệ môi trường năm 2020 quy định như sau:
Ví dụ: Thông tư số 25/2009/TT-BTNMT ngày 16 tháng 11 năm 2009 của Bộ Tài nguyên và Môi trường về ban hành Quy chuẩn quốc gia về môi trường. Trong đó, QCVN 19: 2009/BTNMT về Quy chuẩn kỹ thuật quốc gia về khí thải công nghiệp đối với bụi và các chất vô cơ. Xem thêm: Tổng hợp bài viết về luật bảo vệ môi trường Luật Hoàng Anh Media Release Santhera and ReveraGen Announce Positive and Statistically Highly Significant Topline Results with Vamorolone in Pivotal VISION-DMD Study
Pratteln, Switzerland, and Rockville, MD, USA, June 1, 2021 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce positive key results from the VISION-DMD study, demonstrating robust efficacy across multiple efficacy endpoints and favorable safety and tolerability of vamorolone in the treatment of patients with DMD. VISION-DMD is a pivotal Phase 2b study designed to demonstrate efficacy and safety of vamorolone compared to placebo and prednisone (active control) in the treatment of DMD. In the first 24-week double-blind period, of which the topline data readout is presented here, 121 ambulant boys aged 4 to <7 years with DMD were randomized to receive vamorolone (low dose 2 mg/kg/day or high dose 6 mg/kg/day) or prednisone (0.75 mg/kg/day) or placebo. A second period of 24 weeks, where all participants receive vamorolone treatment on either of the two dose levels, will continue to capture additional longer term safety and tolerability data. Vamorolone demonstrates efficacy across primary and secondary endpoints and over a broad dose
range Vamorolone showed a favorable safety and tolerability profile over prednisone As previously published, in open-label studies of 2.5 years duration (113 patient years), vamorolone did not show stunting of growth as reported with conventional corticosteroids. Particularly noteworthy, this was validated in the current 24-week double-blind study where vamorolone 6 mg/kg/day versus prednisone 0.75 mg/kg/day showed a significant difference in growth velocity (p=0.02). “Stunting of growth is a major concern of families and patients treated with corticosteroids, and we are delighted to see this superiority of vamorolone proven in this double-blind study,” said Paula Clemens, MD, study Co-Chair, and Vice Chair of VA Affairs and Professor of Neurology, University of Pittsburgh School of Medicine. “Today’s news is a tremendous milestone for patients and Santhera as we further advance vamorolone as a foundational treatment option in DMD. The treatment effect translates into the potential to delay disease progression by about two years and indicates disease modifying potential of vamorolone,” said Dario Eklund, Chief Executive Officer of Santhera. “We now look forward to working with regulatory authorities to bring vamorolone to DMD patients, first in the US and subsequently in Europe. “We are thrilled about the positive results of the VISION-DMD study as it represents a culmination over a decade of scientific research,” said Eric Hoffman, PhD, President and CEO at ReveraGen BioPharma and Professor of Pharmaceutical Sciences, Binghamton University – State University of New York. “We are grateful to have been able to gather such important data and would like to thank all VISION-DMD participants, their families and caregivers, as well as investigators and study personnel, for their commitment to this ongoing program.” “The strength of evidence for both efficacy and safety of vamorolone over such a wide dose range from 2 to 6 mg/kg/day allows clinicians to individually tailor treatment of Duchenne patients by starting at the higher 6 mg/kg/day dose of vamorolone with equivalent efficacy to daily prednisone and titrate the dose according to how well the treatment is tolerated whilst maintaining optimal efficacy. I am enthusiastic that this approach may allow patients to avoid side effects that currently lead to discontinuing steroid treatment, meaning they are able stay on for longer,” said Craig McDonald, MD, Professor and Chair, Department of Physical Medicine & Rehabilitation and Director of Neuromuscular Disease Clinics, UC Davis Health, USA. Santhera plans to submit a New Drug Application (NDA) in the US in Q1-2022, requesting a priority review based on the fast track designation granted by the FDA. The VISION-DMD study continues to 48 weeks and will, subject to a positive outcome, deliver data for the submission of a marketing authorization application in Europe in Q2-2022. Upon approval, Santhera intends to commercialize vamorolone for the treatment of DMD through its own organization in the United States and main markets in Europe, and is seeking collaborations outside those regions for DMD and for additional indications worldwide. Santhera estimates the peak sales potential for vamorolone in the indication DMD alone to be in excess of USD 500 million in the US and the largest five European countries combined. Vamorolone has been granted Orphan Drug status in the US and in Europe, and has received Fast Track and Rare Pediatric Disease designations by the US FDA and Promising Innovative Medicine (PIM) status from the UK MHRA. On September 2, 2020, Santhera signed agreements with ReveraGen and Idorsia that granted Santhera an exclusive license to vamorolone for all indications worldwide. Santhera Webcast About VISION-DMD About Vamorolone Vamorolone was discovered by US-based ReveraGen BioPharma, Inc. and is being developed in collaboration with Santhera, which owns worldwide rights to the drug candidate in all indications. The vamorolone development program has received funding from several international non-profit foundations and patient organizations, the US National Institutes of Health, the US Department of Defense and the European Commission’s Horizon 2020 program. About Duchenne Muscular Dystrophy About Santhera About ReveraGen BioPharma For further information please contact: Santhera ReveraGen BioPharma Disclaimer / Forward-looking statements Media Release ReveraGen BioPharma Completes 2.5 Years Vamorolone Treatment of 41 Duchenne Muscular Dystrophy BoysRockville, MD – Vamorolone is a first-in-class daily oral drug being developed to improve muscle function in Duchenne muscular dystrophy. Vamorolone has multiple mechanisms of action shown by published pre-clinical studies, including potent anti-inflammatory activities, cardioprotective activity, promotion of membrane repair, and synchronization of cell repair. While a steroidal drug, pre-clinical and clinical data has shown that vamorolone may lack multiple safety concerns of corticosteroidal anti-inflammatories, such as deflazacort and prednisone, while adding novel aspects of potential efficacy such as mineralocorticoid antagonism. In 2016-2017, 48 DMD boys (age 4 to <7 years) entered a series of pharmacokinetics, safety and dose-finding efficacy studies (VBP15-002; VBP15-003). After 6-months of treatment, the DMD participants and their families were given the option to transition to standard of care (deflazacort or prednisone), or remain on vamorolone via a 2-year long-term extension study (VBP15-LTE). Of the 46 DMD boys completing the 6-month dose-ranging study, all (100%) requested to continue vamorolone treatment in the long-term extension, rather than transition to corticosteroids. The last participant, last visit of VBP15-LTE occurred in April 2020, with 41 of 46 DMD boys completing the full 2-year treatment period. The large majority of the 41 DMD boys completing the 2-year LTE have transitioned to Expanded Access Program (USA, Canada, Israel), or compassionate use programs (UK, Sweden, Australia). “Parents and their physicians seem to be satisfied with vamorolone, as nearly all wish to continue vamorolone treatment,” said Paula Clemens, MD, Professor at the University of Pittsburgh School of Medicine, and Study Chair. The long-term extension study enabled dose escalation and de-escalation at the preference of the physician and family (suggested range 2.0 to 6.0 mg/kg/day). Of those 41 participants completing the 2-year end-of-study visit, 27 ended at 6.0 mg/kg/day (66%), 11 at 2.0 mg/kg/day (27%), and 3 at 4.0 mg/kg/day (7%). Thus, the majority (2/3) of physicians/families chose treatment at the highest tested dose of vamorolone by the end of the LTE study (6.0 mg/kg/day). “With most participants continuing treatment with vamorolone long-term, we have assembled a strong safety database, with 106 patient-years of vamorolone exposure in DMD boys, with no serious adverse events attributable to vamorolone to date,” said Eric Hoffman, PhD, Vice President of Research at ReveraGen BioPharma. A registration trial, VBP15-004, is ongoing with 103 of 128 DMD participants enrolled. Enrollment is expected to complete soon, with 6-month read-out for FDA NDA submission in 4Q2020 or 1Q2021. Information on the VBP15-004 trial can be obtained from Suzanne Gaglianone () or Andrea D’Alessandro (). Media contacts: NOTES: About Duchenne muscular dystrophy About ReveraGen BioPharma About vamorolone [1] Heier CR at al. (2013). VBP15, a novel anti‐inflammatory and membrane‐stabilizer, improves muscular dystrophy without side effects. EMBO Mol Med 5: 1569–1585 [2] Heier CR et al. (2019). Vamorolone targets dual nuclear receptors to treat inflammation and dystrophic cardiomyopathy. Life Science Alliance DOI 10.26508/lsa.201800186 [3] Hoffman EP et al. (2018). Phase 1 trial of vamorolone, a first-in-class steroid, shows improvements in side effects via biomarkers bridged to clinical outcomes. Steroids 134: 43-52. [4] Conklin LS et al. (2018). Phase IIa trial in Duchenne muscular dystrophy shows vamorolone is a first in-class dissociative steroidal anti-inflammatory drug. Pharmacological Research 136:140-150. [5] Hoffman EP et al. (2019). Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function. Neurology 93: e1312-e1323 About the Cooperative International Neuromuscular Research Group (CINRG) Media Release NS Pharma Announces Publication of Clinical Trial Data for Viltolarsen in DMD Patients in JAMA NeurologyPARAMUS, NJ – NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President Shigenobu Maekawa), announced today that JAMA Neurology has published results from a clinical trial of viltolarsen, an investigational agent being evaluated in Duchenne muscular dystrophy (DMD) patients who are amenable to exon 53 skipping therapy. “In this study, 100% of patients were shown to have more dystrophin after treatment with viltolarsen and 88% achieved dystrophin levels of greater than 3%,” said lead study author and investigator Paula Clemens, MD, University of Pittsburgh School of Medicine. “These increases were seen in patients as young as four years of age and after six months or less of treatment, which underscores the impressive results seen in this study.” This Phase 2, two-period, dose-finding study enrolled 16 DMD patients, from four to less than 10 years of age, who were amenable to exon 53 skipping therapy. Study participants were randomized to two doses of viltolarsen (40 mg/kg/wk and 80 mg/kg/wk) for 20 to 24 weeks. At the end of the study, treatment with viltolarsen was associated with statistically significant increases in mean dystrophin expression (40 mg/kg/wk: p<0.001; 80 mg/kg/wk p=0.012). Mean dystrophin levels of 5.7% and 5.9% were observed in comparison to mean baseline levels of 0.3% and 0.6% in the 40 mg/kg/wk and 80 mg/kg/wk groups, respectively. Fourteen out of 16 patients (88%) reached dystrophin levels greater than 3%. The most common treatment emergent adverse events occurring in greater than one patient were: cold, cough, nasal congestion, bruising, joint pain, diarrhea and vomiting. No serious adverse events were observed in the study. “Lack of functional dystrophin is recognized as the singular underlying cause of the devastating impact of DMD,” said study author and investigator Vamshi Rao, MD, Ann & Robert H. Lurie Children’s Hospital of Chicago. “As a pediatric neurologist who specializes in the treatment of DMD, I am encouraged by the dystrophin increases observed in this study and the potential of viltolarsen to address the underlying cause of DMD.” “This is one of the first studies of exon skipping therapies in DMD to generate rigorous data on the primary biomarker of dystrophin protein,” said study author Eric Hoffman, PhD, Associate Dean for Research and Professor of Pharmaceutical Sciences at Binghamton University. “Having assisted in the development of viltolarsen for many years, and decades more researching the genetics and genomics of DMD, I am pleased by the results of this study and the implications for families facing DMD.” Viltolarsen has not yet been approved in the U.S. and its New Drug Application was recently granted Priority Review by the FDA with an anticipated action date in the third quarter of 2020. In March 2020, viltolarsen was approved in Japan for the treatment of DMD patients amenable to exon 53 skipping therapy. “We are deeply committed to the development of viltolarsen and offering healthier futures to DMD patients and families,” said Tsugio Tanaka, President, NS Pharma, Inc. “Based on these results we are optimistic that, if it is approved, viltolarsen will become an important new treatment option for DMD patients and healthcare providers.” NS Pharma continues to study the safety and efficacy of viltolarsen in the confirmatory Phase 3 RACER53 trial. This study was initiated in October 2019 and is currently enrolling. The purpose of this Phase 3 trial is to confirm the clinical findings that were submitted under the Accelerated Approval pathway. About Duchenne Muscular Dystrophy (DMD) About Viltolarsen About NS Pharma, Inc. Contact SOURCE NS Pharma Related
Links Media Release Vamorolone Designated Promising Innovative Medicine (PIM) for treatment in Duchenne muscular dystrophyRockville, MD – In the UK the Early Access to Medicines Scheme (EAMS) is a regulatory path by the MRHA that aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need. The initial step in this process is Promising Innovative Medicine (PIM) designation. Co-founders of Duchenne UK Alex Johnson and Emily Crossley said, “We are delighted that MHRA has given PIM status to Vamorolone as a treatment for Duchenne Muscular Dystrophy. A PIM designation is the first step of a process that could allow patients earlier access to a new medicine. This is part of the Early Access to Medicines Scheme which Duchenne UK and Joining Jack lobbied for in 2014. We are pleased to see that the scheme may be used for Vamorolone.” UK foundations that have aided the development of vamorolone for DMD include Joining Jack, Duchenne Children’s Trust, ActionDuchenne, Alex’s Wish Foundation, and Duchenne Research Fund. Vamorolone is a first-in-class drug that targets multiple biochemical pathways in DMD patient muscle simultaneously, and in initial open label studies has shown improvements of patient muscle function. A pivotal trial that may lead to drug approval is currently enrolling patients age 4 to 7 years at 6 sites in the United Kingdom (Newcastle University, Royal Hospital for Children [Glasgow], Alder Hey Children’s Hospital [Liverpool], Leeds Teaching Hospital Trust, Great Ormond Street Institute of Child Health [London] and University Hospitals Birmingham). Information on the currently recruiting vamorolone clinical trial with contact information for UK recruitment sites can be found at clinicaltrials.gov. About the UK Early Access to Medicines Scheme (EAMS) The UK’s industry-sponsored EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need. The EAMS is a two-step process: Step I is the Designation as a Promising Innovation Medicine (PIM). The PIM designation is an early indication that a medicinal product is a promising candidate for EAMS and gives reassurance that its clinical development is on track by having an early review of its data by the medicines regulator. Step II is the Scientific Opinion by the Medicines and Healthcare products Regulatory Agency (MHRA, UK regulatory agency). The Scientific Opinion describes the benefits and risks of the medicine and supports the prescriber and patient to make a decision on using the medicine before its license is approved. |