7 - 2024 - Tamfis

Amity Global Institute Achieves 4-Year EduTrust Certification Renewal, Business News

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SINGAPORE – Media OutReach Newswire – 29 July 2024 – Amity Global Institute is proud to announce the successful renewal of its 4-year EduTrust Certification for the third consecutive term, awarded by the Committee for Private Education (CPE), part of SkillsFuture Singapore (SSG). This prestigious certification underscores our unwavering commitment to excellence in education and institutional management.

The EduTrust Certification is a quality assurance scheme awarded to Private Education Institutions (PEIs) that demonstrate exemplary performance in managing their institutions and providing high-quality education and student welfare. The certification process evaluates institutions across seven key criteria: management commitment and responsibilities, corporate governance, student protection and support services, academic processes and student assessment, achievement of student and graduate outcomes, quality assurance, and continual improvement.

In their assessment, the CPE commended Amity Global Institute for its outstanding performance in several areas, including recruitment, student care, academic offerings, research, and investment in infrastructure and facilities. This achievement reflects the dedication and hard work of our entire team, as well as the support of our partners and students.

“We are honoured to receive this certification renewal, which validates our continuous efforts to provide exceptional education and support to our students,” said Professor (Dr) Leon Choong, Regional CEO (ASEAN) of Amity Global Institute. “We remain committed to ongoing improvement and innovation in all aspects of our institution, ensuring that we meet the highest standards of quality and excellence.”

As we celebrate this milestone, we remain dedicated to enhancing our students’ educational experience, fostering a supportive and enriching environment, and making a positive impact on the broader educational landscape by championing education without boundaries.
Hashtag: #AmityGlobalInstitute #AGI

The issuer is solely responsible for the content of this announcement.

About Amity Global Institute:

Amity Global Institute is a private education institution in Singapore dedicated to providing high-quality education and fostering its students’ personal and professional growth. Our comprehensive range of programmes, state-of-the-art facilities, and unwavering commitment to excellence position us as a top choice for students seeking a world-class education. We are dedicated to nurturing the personal and professional growth of each and every student who walks through our doors.

Amity Global Institute, part of the esteemed Amity Education Group, was established four decades ago. Amity Education Group is a not-for-profit foundation managing universities and schools worldwide. With 200,000 students annually, 700,000 alums, and 6,000 faculty, we prioritise international exposure and essential life skills. We vow to nurture every student’s resolve, effort, and commitment from day one.

Menarini Announces Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Efficacy, Safety and Tolerability of Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia, Business News

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—Achieved primary endpoint of LS mean reduction in LDL-C on top of maximally tolerated lipid modifying therapies at week 12 with statistically significant reduction (p<0.0001), which was sustained at week 52 (p<0.0001) --

— Obicetrapib lowered LDL-C by 36.3% at week 12 and by 41.5% at week 52, compared to placebo —

— Obicetrapib was well-tolerated; safety results comparable to placebo—

FLORENCE, Italy, July 29, 2024 /PRNewswire/ — Menarini Group today announces positive topline data from the Phase 3 BROOKLYN clinical trial (NCT05425745) sponsored by NewAmsterdam Pharma Company N.V. (“NewAmsterdam”), a biopharmaceutical company which granted the Menarini Group an exclusive license to commercialize obicetrapib in Europeeither as a monotherapy or as part of a fixed dose combination with ezetimibe, for cardiovascular diseases. The phase 3 BROOKLYN clinical trial (NCT05425745), the first of four studies in NewAmsterdam’s pivotal clinical development program, was designed to evaluate obicetrapib in adult patients with heterozygous familial hypercholesterolemia (“HeFH”), whose low-density lipoprotein cholesterol (“LDL-C”) level is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.

The BROOKLYN trial met its primary endpoint, achieving a LS mean reduction of 36.3% (p <0.0001) compared to placebo at week 12, which was sustained at 52 weeks with a LS mean LDL-C reduction of 41.5% (p <0.0001). Over 50% of patients achieved an LDL-C level below 70 mg/dl. The reductions in other biomarkers, including non-HDL-C, ApoB, and Lp(a), met statistical significance and were consistent with prior studies.

In the study, obicetrapib proved to be well-tolerated, with no increase in blood pressure. Any study drug related treatment emergent adverse events occurred in 6.8% patients in the placebo arm versus 4.3% patients in obicetrapib arm and no study drug related treatment emergent serious events were reported in both treatment arms. The treatment discontinuation rate for obicetrapib was 7.6% versus 14.4% for placebo.

“BROOKLYN data has confirmed obicetrapib’s ability to significantly reduce LDL-C in HeFH patients, a population already on multiple lipid-lowering therapies. I am incredibly encouraged by these results, which suggest we may have a new, high-efficacy, oral option for a difficult-to-treat patient population“said Stephen NichollsM.B.B.S., Ph.D., Director, Monash Victorian Heart Institute and Professor of Cardiology, Monash University and principal investigator of the entire obicetrapib development program.

“Heterozygous Familial Hypercholesterolemia, or HeFH, affects 1 in 250 people worldwide and leads to increased risk of major adverse cardiovascular events, including stroke, myocardial infarction, or death, which often occur at a younger age than in the general population. While it’s widely acknowledged that the increased risk is driven by elevated levels of LDL-C, many HeFH patients are unable to attain guideline-recommended LDL-C levels, despite currently available treatment options,” said Katherine Wilemon Founder and CEO of the Family Heart Foundation. “HeFH patients are difficult to treat, often requiring multiple therapies to control their LDL-C levels. We are highly encouraged with these results and the potential to have another efficacious oral option.”

“Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives each year. Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets. Patients and their doctors need additional options. We are very pleased that BROOKLYN confirmed the ability of obicetrapib to significantly reduce LDL-C in a challenging patient population, over a duration of one year. This represents an important milestone in our commitment to offer the HeFH community in Europe a potential first in class, oral CETP-i in the fight against cardiovascular diseases, a mission of over 30 years for our company”, said Elcin Barker ErgunChief Executive Officer of the Menarini Group.

Design of the Pivotal Phase 3 BROOKLYN Clinical Trial

The 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter study evaluated the efficacy and safety of 10 mg obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with HeFH whose LDL-C is not adequately controlled. The study was conducted at sites in North America, Europe and Africa. A total of 354 patients were randomized 2:1 to receive 10 mg obicetrapib or placebo dosed as a once-daily oral treatment, with or without food. The mean baseline LDL-C for enrolled patients in the obicetrapib arm was 123 mg/dL despite high intensity statin use reported by approximately 79% of patients during screening. Females comprised approximately 53% of the study population and the median age of participants at baseline was 57 years.

The primary objective was to evaluate the effect of obicetrapib on LDL-C levels. Secondary objectives include evaluating the effect of obicetrapib on non-high-density lipoprotein cholesterol (“non-HDL-C”), apolipoprotein B (“ApoB”), and lipoprotein (a). The trial also evaluated the safety and tolerability profile of obicetrapib.

Obicetrapib’s Global Pivotal Phase 3 Program

Obicetrapib global, pivotal Phase 3 clinical development program consists of four studies in over 12,250 patients, three for obicetrapib monotherapy and one for a fixed-dose combination (“FDC”) with ezetimibe:

– BROOKLYN evaluated obicetrapib in patients with HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05425745). Topline data reported in the third quarter of 2024.

– BROADWAY is evaluating obicetrapib in adult patients with established ASCVD and/or HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05142722). Study enrollment of over 2,500 patients was completed in July 2023 and topline data are expected to be reported in the fourth quarter of 2024.

– TANDEM is evaluating obicetrapib as part of a FDC tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy (NCT06005597). Study enrollment of over 400 patients was completed in July 2024 and topline data are expected to be reported in the first quarter of 2025.

– PREVAIL is a cardiovascular outcomes trial (“CVOT”) evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy (NCT05202509). Study enrollment of over 9,500 patients was completed in April 2024.

About Obicetrapib

Obicetrapib is a novel, under development, oral, low-dose CETP inhibitor to overcome the limitations of current LDL-lowering treatments. In each of the Phase 2 trials, ROSE, ROSE2, TULIP, and OCEAN, evaluating obicetrapib as monotherapy or in combination therapy, it was observed a statistically significant LDL-lowering combined with a good tolerability. Obicetrapib is being investigated in other three Phase 3 pivotal trials, BROADWAY and PREVAIL, evaluating obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering and cardiovascular protection for cardiovascular disease (“CVD”) patients and TANDEM, evaluating obicetrapib and ezetimibe as a fixed-dose combination. Patients enrollment in BROADWAY began in January 2022and in TANDEM in March 2024; enrollment of BROADWAY was completed in July 2023and TANDEM in July 2024. The Phase 3 PREVAIL cardiovascular outcomes trial, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization, commenced in March 2022 and the enrollment was completed in April 2024 with over 9,500 patients randomized.

About The Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas of high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com.

About NewAmsterdam

NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.

MAK in India: From Thiruchengode to global stage

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Manickam Athappa Gounder walked six km to school for six years to clear SSLC. This farmer’s son from a small village called Pazhayapalayam in Thiruchengode taluk went on to do electronics and computer engineering (ECE) at PSG Tech in Coimbatore in the early 1970s. Over the next 50 years, he set up MAK Controls & Sytems, India, and Air MAK Industries, USA.
MAK, as he now calls himself after his US exposure, has handed over the day-to-day operations of his mainstream business to a team of young professionals that includes his son.

He now works with farmers in Panruti, Salem and Erode to improve productivity, walking with them to prevent pollution of Noyyal river by Tirupur dyers; supplies sewage cleaning kits for household septic tanks in cities such as Chennai; and makes paver blocks from non-biodegradable waste.
“Like so many others in the 1940s-50s, I was born to a poor farmer. But my father was not poor at heart. Responding to a call from chief minister K Kamaraj, he built a primary school in our village, in which I studied,” says MAK, now 75.
After high school, he joined a five-year engineering course at PSG Tech, Coimbatore, where education was free and he had to pay only the hostel fees. The institution even arranged a loan for him at `5,000 per annum.

“I got a job offer from the Indian Navy during my fourth year itself. My father did not permit me to take it. After completing the five-year course, most of us got offers to study for free in the US. But my father reminded me of the free education provided by Kamaraj to people in Tamil Nadu and wanted me to do something here itself,” he says.
“Instead of working, I wanted to set up my own business and started one in 1973 with `15,000 I saved during my college days. From the beginning, I decided I will make only proprietary products for requirements of industries,” he says. The big break came when Leyland had a problem handling its 72 engine beds to test engines. Batteries were used to start the engines, but they lasted only two starts. They had to replace the batteries at least three times a day and a large team was employed just to handle that. “I studied the problem, created a rectifier that was attached to each engine bed and there was no need to change the batteries. Word of mouth spread and we got orders from abroad,” says MAK.

In the next phase, the company made ‘rectifiers’ for the six sea harrier aircraft that Indian Navy had stationed in Goa. “The aircraft are long gone, but our rectifiers are still working. This association next took us to the Indian missile programme, for which we supplied the ground power units (GPUs). We also were the first to supply diesel-driven GPUs for the grounded A320s in India and later to other airlines abroad. Today we supply the GPUs for all Indian missiles including Brahmos, as well as to aircraft with the Indian Air Force,” adds MAK.
To cut a long story short, the company entered the US in 1997 and went on to develop diesel GPUs and air start units for aircraft and engines for leading aerospace companies. “We showed them what we can do in manufacturing, offering critical solutions by establishing a base in their own country. All research work happens here in Coimbatore with our own engineers,” he says.
MAK Control, which has a turnover of around `300 crore, now employs more than 800 people here. “My focus is on two things now – improve farm productivity and farmers’ earnings by laying thrust on organic farming and reducing the use of chemical fertilisers. We have developed off-the-shelf organic manure and pesticides. The other focus is to address the threat of pollution, especially from urban sewage, by getting to the root of the problems at the source,” he says.