Aduhelm drug set to undergo its first real world observational phase 4 study

WORLD – Biogen and Eisai have presented a design of the first real-world observational phase 4 study in Alzheimer’s disease by the name ICARE AD-US. ICARE AD-US, a prospective study of Aduhelm (aducanumab-avwa) solution for injection, is designed to collect real-world, long-term effectiveness and safety data on Aduhelm. The study design includes an important goal to help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer’s disease studies, aiming to enroll at least 16 percent of the trial’s expected 6,000 participants from these communities. ICARE AD-US is…

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GlaxoSmithKline’s chronic rhinosinusitis drug therapy gains FDA’s approval

UK – The US Food & Drug Administration (FDA), has approved GlaxoSmithKline’s interleukin-5 (IL-5) inhibitor that will be used to treat chronic rhinosinusitis with nasal polyps (CRSwNP). FDA has cleared Nucala as an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. The approval is based on data from GSK’s SYNAPSE study which evaluated the effect of Nucala versus placebo in over 400 patients with CRSwNP. In this trial, Nucala achieved significant improvement in reducing the size of nasal…

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Thousands of children in Tigray at risk of death from malnutrition

ETHIOPIA – More than 100,000 children in Ethiopia’s northern region of Tigray could suffer from life-threatening malnutrition in the next 12 months, a 10-fold jump over average annual levels, the U.N. Children’s Fund (UNICEF) has said. UNICEF spokeswoman Marixie Mercado, speaking after returning from Tigray, said that one in two pregnant and breastfeeding women screened in the region were acutely malnourished, leaving them and their babies prone to sickness. “Our worst fears about the health and wellbeing of children in that conflicted region of northern Ethiopia are being confirmed,” she…

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ASR Africa adopts Gwarimpa General Hospital Neonatal Unit while delivering hefty donations

NIGERIA – The Abdul Samad Rabiu Africa Initiative (ASR Africa) has donated multimillion state-of-art equipment and a fully equipped emergency ambulance to the Pediatric Unit of the Gwarimpa General Hospital, Abuja as part of its Health Systems Support Initiative. ASR Africa also announced that it was adopting the Neonatal Unit of the hospital under this initiative as well as providing N500,000 towards a fund being setup to assist indigent patients in accessing quality healthcare at the hospital. They will also replace all the equipment in the neonatal unit as well…

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Macomics bags £4.24m (US$5.92m) as it aims to accelerate macrophage-based therapeutics portfolio

UK – Macomics, a UK immuno-oncology company, has raised £4.24m in follow-on financing from its 2020 seed round as it aims to accelerate the development of its macrophage-based therapeutics portfolio. The new investment and planned Series A financing will enable Macomics to accelerate progress if its antibody programmes toward the clinics while also expanding its portfolio and further investing in its target discovery technology. Its target discovery platform will enable the identification and validation of novel macrophage therapeutic targets, based on a ‘deep understanding of macrophage biology’. The company also…

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Helios partners Abderraouf Sordo to create the largest MedTech distribution group in Africa

MOROCCO – Helios Investment Partners, leader in private equity in Africa with more than US$3.6 billion in assets under management, has reached an agreement to acquire a majority stake in the largest Moroccan group in the MedTech sector. “We are extremely excited about the next step in our development alongside Helios, leader in private equity in Africa,” Abderraouf Sordo, Founder and CEO of the Group, said. This partnership will play a central role in helping the group to realize their growth strategy, improve service delivery while consolidating their leadership position…

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Sigh of relief for people with diabetes as FDA approves first biosimilar insulin product

US – The U.S. Food and Drug Administration (FDA) has approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Approvals of these insulin products is set to provide diabetic patients with additional safe, high-quality and potentially cost-effective options for treating diabetes. Semglee, the approved insulin product, is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine), a long-acting insulin analog. Biological products include medications for treating…

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Kenyan nurses given chance to work in UK under new Kenya-UK health agreements

KENYA – Unemployed nurses and health workers from Kenya will have the chance to work in the UK as part of a new scheme requested by the Government of Kenya and launched by President Kenyatta during his visit to London. In a programme to share knowledge and expertise, Kenyan health professionals and health managers will benefit from a special route to work in the UK, before returning to work in Kenya’s health sector. The agreement is open to Kenya’s surplus health workers who are qualified but unemployed, ensuring the process…

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Ipsen, BAKX Therapeutics collaborate to broaden their oncology therapy portfolio

EUROPE – Ipsen, a French based company, has entered into collaboration with BAKX Therapeutics with an aim to focus on an oral small-molecule activator of BAX for the potential treatment of leukemia, lymphoma and solid tumors. Under the terms of the deal, Ipsen will collaborate with BAKX Therapeutics to research, develop, manufacture and commercialize BKX-001 in these oncology indications. BAX is a novel target in the apoptosis cell-signaling pathway apoptosis is the naturally occurring process of programmed cell death. Global Immuno- oncology clinical trials market Based on a report from…

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African death toll from COVID-19 jumps 17% in the wake of the Delta variant

AFRICA – The Africa Centers for Disease Control and Prevention (CDC) says the continent’s death toll from COVID-19 has jumped 17 percent in the past month. In a media briefing, the Africa CDC said the infection rate has also increased and warned some countries are testing less often for the virus than needed. In his weekly online press briefing from Ethiopia, the head of the Africa Centers for Disease Control and Prevention, John Nkengosong, gave a grim picture of the continent’s COVID-19 situation during the month of July. “There has…

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