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Novo Nordisk A/S: Semaglutide 2.4 mg demonstrates superior improvement in both liver fibrosis and MASH resolution in the ESSENCE trial

November 3rd, 2024 2:40 am

Bagsværd, Denmark, 1 November 2024 – Novo Nordisk today announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3)1. Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care for the first 800 randomised people at 72 weeks.

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Novo Nordisk A/S: Semaglutide 2.4 mg demonstrates superior improvement in both liver fibrosis and MASH resolution in the ESSENCE trial

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Galecto Reports Third Quarter 2024 Financial Results

November 3rd, 2024 2:40 am

-  Completed strategic review to focus on oncology and severe liver diseases

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Galecto Reports Third Quarter 2024 Financial Results

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Shares Expected to Begin Trading on Split-Adjusted Basis on November 5, 2024

November 3rd, 2024 2:40 am

CARLSBAD, Calif., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the “Company”) announced today that it will implement a 1-for-50 reverse stock split of the issued shares of its common stock (the "Reverse Stock Split"), effective at 12:01 a.m. Eastern time on November 5, 2024. The Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on Tuesday, November 5, 2024, and will continue to trade on The Nasdaq Capital Market under the symbol "QLGN." The new CUSIP number for the common stock will be 74754R 301.

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Shares Expected to Begin Trading on Split-Adjusted Basis on November 5, 2024

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Zealand Pharma conference call on November 7 at 2pm CET (8am ET) to present third quarter 2024 financial results

November 3rd, 2024 2:40 am

Press Release – No. 10 / 2024

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Zealand Pharma conference call on November 7 at 2pm CET (8am ET) to present third quarter 2024 financial results

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Tiziana Life Sciences to Participate in BIO-Europe 2024 to Discuss Recent Clinical Advancements, Including Positive GLP-1 Combination Study Data

November 3rd, 2024 2:40 am

NEW YORK, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced its participation in the BIO-Europe 2024 conference, taking place November 4-6 in Stockholm, Sweden. As part of the conference’s partnering meetings, Tiziana will engage with industry leaders, potential collaborators, and investors to discuss recent clinical progress, including data from its combination study involving Ozempic, a GLP-1 agonist.

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Tiziana Life Sciences to Participate in BIO-Europe 2024 to Discuss Recent Clinical Advancements, Including Positive GLP-1 Combination Study Data

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Teva Presents Latest Schizophrenia Treatment Research, Including Phase 3 SOLARIS Trial Results Demonstrating Improvements in Social Functioning and…

November 3rd, 2024 2:40 am

TEL AVIV, Israel & PARSIPPANY, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new, positive data on social functioning and quality of life from the Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial evaluating TEV-'749 in adult patients diagnosed with schizophrenia. In the acute treatment phase of the study (Period 1), TEV-'749 demonstrated significant improvement in social functioning and quality of life across multiple validated measures from baseline to week 8. The systemic safety profile of TEV-'749 was consistent with other approved oral formulations of olanzapine, with no new safety signals identified and no PDSS events reported to date.1 In addition, in vitro data and interim results from a Phase 1 study evaluating the pharmacokinetic characteristics of TEV-'749 validate that its route of administration and drug delivery technology may effectively address the risk of PDSS development.1 These studies, highlighting the patient focused outcomes, were presented at Psych Congress 2024 taking place from October 29 – November 2, 2024, in Boston, MA.

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Teva Presents Latest Schizophrenia Treatment Research, Including Phase 3 SOLARIS Trial Results Demonstrating Improvements in Social Functioning and...

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Teva Presents New Tardive Dyskinesia Data at Psych Congress 2024 from the IMPACT-TD Registry, Revealing Differences in Patient Experience Based on…

November 3rd, 2024 2:40 am

TEL AVIV, Israel and PARSIPPANY, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, revealing differences between TD patients with a psychotic disorder and those with a mood disorder. The IMPACT-TD Registry is the largest study of its kind evaluating the holistic effects of TD, showing real-world treatment patterns and outcomes with once-daily AUSTEDO® XR® (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO (deutetrabenazine) tablets. Teva also announced interim data from a patient-reported survey describing early, real-world experience with AUSTEDO XR. These findings are being presented at the Psych Congress 2024 taking place from October 29 – November 2 in Boston, MA.

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Teva Presents New Tardive Dyskinesia Data at Psych Congress 2024 from the IMPACT-TD Registry, Revealing Differences in Patient Experience Based on...

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Universe Pharmaceuticals INC Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

November 3rd, 2024 2:40 am

Ji’an, Jiangxi, China, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Universe Pharmaceuticals INC (the “Company”) (Nasdaq: UPC), a pharmaceutical producer and distributor in China, today announced that the Company received a written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("Nasdaq") on October 25, 2024, notifying the Company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Listing Rules for continued listing on the Nasdaq.

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Universe Pharmaceuticals INC Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

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Disc Medicine to Host Conference Call on End of Phase 2 FDA Meeting for Bitopertin in Erythropoietic Protoporphyria (EPP)

November 3rd, 2024 2:39 am

WATERTOWN, Mass., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, will host a conference call to discuss feedback received from its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). The conference call will be held on Monday, November 4, at 8:00 am EST.

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Disc Medicine to Host Conference Call on End of Phase 2 FDA Meeting for Bitopertin in Erythropoietic Protoporphyria (EPP)

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Lipella Pharmaceuticals Announces 1-for-8 Reverse Stock Split

November 3rd, 2024 2:39 am

PITTSBURGH, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (the “Company,” “our” or “us”), a clinical-stage biotechnology company focused on developing innovative therapies for serious diseases with unmet medical needs, today announced that it intends to effect a 1-for-8 reverse stock split of its common stock effective as of 5:00 p.m. Eastern Time on November 7, 2024 upon the filing of a certificate of amendment to the Company’s certificate of incorporation with the Secretary of State of the State of Delaware. The Company expects that its common stock will begin trading on a split-adjusted basis when the market opens on November 8, 2024, under its current trading symbol “LIPO.” Following the reverse stock split, the CUSIP number for the Company’s common stock will be updated to 53630L209.

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Lipella Pharmaceuticals Announces 1-for-8 Reverse Stock Split

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Conduit Pharmaceuticals Announces Debt Restructuring and Additional Notes

November 3rd, 2024 2:39 am

SAN DIEGO and LONDON, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Conduit Pharmaceuticals Inc. (Nasdaq: CDT) (“Conduit” or the “Company”), today announced the restructuring of a portion of its financial obligations, enhancing its balance sheet and liquidity. The Company has restructured the $2.65 million loan note with Nirland Limited (“Nirland”) and secured $1.2 million in new promissory notes through separate agreements with third parties.

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Conduit Pharmaceuticals Announces Debt Restructuring and Additional Notes

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NurExone Biologic Closes Final Tranche of Non-Brokered Private Placement and Provides Corporate Update

November 3rd, 2024 2:39 am

TORONTO and HAIFA, Israel, Nov. 01, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”), a biopharmaceutical company developing exosome-based therapies for the multi-billion dollar regenerative medicinei market, is pleased to announce, further to its press release dated September 26, 2024 (the “September 26 Release”), the closing of the final tranche of its previously announced non-brokered private placement (the “Offering”) for gross proceeds of $127,499.90 (“Tranche 2”). In the Offering, the Company raised aggregate gross proceeds of $1,737,647.45 through the issuance of 3,159,359 Units. Capitalized terms not otherwise defined herein have the meanings attributed to them in the September 26 Release.

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NurExone Biologic Closes Final Tranche of Non-Brokered Private Placement and Provides Corporate Update

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ALX Oncology Announces Results from Phase 1b/2 Trial of Evorpacept in Combination with Zanidatamab will be Presented at the San Antonio Breast Cancer…

November 3rd, 2024 2:39 am

Poster presentation will highlight new data from clinical trial evaluating evorpacept, a highly differentiated investigational CD47 blocker, in combination with zanidatamab, an investigational dual HER2-targeted bispecific antibody, in patients with advanced breast cancers Poster presentation will highlight new data from clinical trial evaluating evorpacept, a highly differentiated investigational CD47 blocker, in combination with zanidatamab, an investigational dual HER2-targeted bispecific antibody, in patients with advanced breast cancers

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ALX Oncology Announces Results from Phase 1b/2 Trial of Evorpacept in Combination with Zanidatamab will be Presented at the San Antonio Breast Cancer...

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WHO launches first World report on vision

October 22nd, 2024 2:40 am

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Main causes of rising cases of vision impairment

Eye conditions that can cause vision impairment and blindness such as cataract, trachoma and refractive error are the main focus of national prevention and other eye care strategies. But eye conditions that do not typically impair vision, including dry eye and conjunctivitis, must not be overlooked as they are among the main reasons for people to seek eye health care services in all countries, the report states.

The combination of a growing and ageing population will significantly increase the total number of people with eye conditions and vision impairment, since prevalence increases with age.

Other main drivers of the most common eye conditions include:

Access to services

Stronger integration of eye care is needed within national health services, including at primary health care level, to ensure that the eye care needs of more people are addressed, including through prevention, early detection, treatment and rehabilitation, the report found.

Dr Alarcos Cieza, who heads WHOs work to address blindness and vision impairment, says: Millions of people have severe vision impairment and are not able to participate in society to their fullest because they cant access rehabilitation services. In a world built on the ability to see, l eye care services, including rehabilitation, must be provided closer to communities for people to achieve their maximum potential.

The report states that all people living with blindness and severe vision impairment who cannot be treated are still able to lead independent lives if they access rehabilitation services. Options include optical magnifiers and reading use Braille, to smartphone wayfinders and orientation and mobility training with white canes.

Read the WHO World report on vision summaryor the full report.

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WHO launches first World report on vision

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Eye health, vision impairment and blindness – World Health Organization …

October 22nd, 2024 2:40 am

Although effective interventions and coverage exist to the Region to address two the leading causes of vision impairment - refractive errors and cataracts countries are working to increase eye care. By 2030, all countries in the Region are working to increase effective coverage of refractive errors by 40% and an increase effective coverage of cataract surgery by 30%. Highly cost-effective interventions for these conditions, including spectacles and cataract surgery can substantially improve a persons quality of life.

Vision impairment that cannot be corrected or reversed requires rehabilitation measures, including low vision aids and assistive technologies. For those living with blindness, braille reading, counselling, home skills training, mobility training with white canes, and digital assistive technologies can ensure free, independent, and safe mobility.

To achieve better visual health in the Region, WHO is working closely with Member States and stakeholders, such as the International Agency for the Prevention of Blindness, The Fred Hollows Foundation, and the Singapore National Eye Care, to plan and deliver Integrated people-centered eye care (IPEC).

Treatment and care for many eye conditions can be improved by implementing IPEC, and promoting comprehensive treatment and intervention across the life course. Additionally, countries are also working to improve data on better treatment processes in order to improve overall care.

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Onchocerciasis – World Health Organization (WHO)

October 22nd, 2024 2:40 am

Onchocerciasis or river blindness is a parasitic disease caused by the filarial worm Onchocerca volvulus transmitted by repeated bites of infected blackflies (Simulium spp.). These blackflies breed along fast-flowing rivers and streams, close to remote villages located near fertile land where people rely on agriculture.

In the human body, the adult worms produce embryonic larvae (microfilariae) that migrate to the skin, eyes and other organs. When a female blackfly bites an infected person during a blood meal, it also ingests microfilariae which develop further in the blackfly and are then transmitted to the next human host during subsequent bites.

Onchocerciasis is an eye and skin disease. Symptoms are caused by the microfilariae, which move around the human body in the subcutaneous tissue and induce intense inflammatory responses when they die. Infected people may show symptoms such as severe itching and various skin changes. Infected people may also develop eye lesions which can lead to visual impairment and permanent blindness. In most cases, nodules under the skin form around the adult worms.

Onchocerciasis occurs mainly in tropical areas. More than 99% of infected people live in 31 countries in sub-Saharan Africa: Angola, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Republic of Congo, Cte dIvoire, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Ghana, Guinea, Guinea-Bissau, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Sudan, Sudan, Togo, Uganda, United Republic of Tanzania.

Onchocerciasis is also transmitted in the Yanomami area of Brazil and Venezuela (Bolivarian Republic of) as well as in Yemen.

Between 1974 and 2002, disease caused by onchocerciasis was brought under control in West Africa through the work of the Onchocerciasis Control Programme (OCP), using mainly the spraying of insecticides against blackfly larvae (vector control) by helicopters and airplanes. This was later supplemented by large-scale distribution of ivermectin since 1989.

The OCP relieved 40 million people from infection, prevented blindness in 600 000 people, and ensured that 18 million children were born free from the threat of the disease and blindness. In addition, 25 million hectares of abandoned arable land were reclaimed for settlement and agricultural production, capable of feeding 17 million people annually.

The African Programme for Onchocerciasis Control (APOC) was launched in 1995 with the objective of controlling onchocerciasis in the remaining endemic countries in Africa and closed at the end of 2015 after beginning the transition to onchocerciasis elimination. Its main strategy was the establishment of sustainable community-directed treatment with ivermectin (CDTI) and vector control with environmentally-safe methods where appropriate. In APOCs final year, more than 119 million people were treated with ivermectin, and many countries had greatly decreased the morbidity associated with onchocerciasis. More than 800,000 people in Uganda and 120,000 people in Sudan no longer required ivermectin by the time that APOC closed.

In 2016, the Expanded Special Project for the Elimination of Neglected Tropical Diseases in Africa (ESPEN), was set up to cover the five preventive chemotherapy NTDs with 4 core objectives:

1. Scale up treatments towards the achievement of 100% geographic coverage, 2. Scale down: stopping treatments once transmission has been interrupted or control achieved, 3. Strengthen information systems for evidence-based action, and 4. Improve the effective use of donated medicines through enhance supply chain management. ESPEN is housed in the WHO Regional Office for Africa.

With support from ESPEN, ivermectin treatments continued to scale up, reaching 152.9 million people in 2019, but due to COVID-19 disruptions, the number of people treated declined by 26.9% in 2020.

The Onchocerciasis Elimination Program of the Americas (OEPA) began in 1992 with the objective of eliminating ocular morbidity and interruption of transmission throughout the Americas by 2015 through biannual large-scale treatment with ivermectin. All 13 foci in this region achieved coverage of more than 85% in 2006, and transmission was interrupted in 11 of the 13 foci. Elimination efforts are now focused on the Yanomami people living in Brazil and Venezuela (Bolivarian Republic of), representing a total population at risk of only 35,228 people.

On 5 April 2013, the Director-General of WHO issued an official letter confirming that Colombia has achieved elimination of onchocerciasis. Colombia was the first country in the world to be verified and declared free of onchocerciasis by WHO. This has been followed by Ecuador in September 2014, Mexico in July 2015, and Guatemala in July 2016. More than 500 000 people no longer need ivermectin in the Americas.

WHO recommends treating onchocerciasis with ivermectin at least once yearly for 10 to 15 years. Where O. volvulus co-exists with Loa loa, treatment strategies may need to be adjusted. Loa loa is a parasitic filarial worm that is endemic in Angola, Equatorial Guinea, Gabon, Cameroon, the Central African Republic, the Republic of Congo, the Democratic Republic of the Congo, Nigeria , Tchad and South Sudan.Treatment of individuals with high levels of L. loa in the blood can sometimes result in severe adverse events. Affected countries, should follow the Mectizan Expert Committee (MEC)/APOC recommendations for the prevention and management of severe adverse events.

WHO provides administrative, technical and operational research support to three regions where onchocerciasis is transmitted.

The Onchocerciasis Technical Advisory Subgroup (OTS) setup by WHO in 2017is providing guidance and oversight for operational research to identify endemic areas that require MDA. In areas co-endemic for lymphatic filariasis, research efforts are focused on developing strategies for co-evaluation of onchocerciasis and lymphatic filariasis, in order to support proper decision making regarding the stopping of MDA.

Diagnosis of onchocerciasis remains a challenge for programmes. The NTD Diagnostics Technical Advisory Group identified development of new diagnostic tools for onchocerciasis as a specific priority. A subgroup was convened to prepare 2 target product profiles (TPPs) for new diagnostics for mapping onchocerciasis and for a confirmatory test for deciding to stop MDA. The TPPs have now been posted on the WHO website.

The WHO Regional Office for Africa, which had an overall supervisory role for OCP from 1975 to 2002 and APOC from 1995 to 2015, currently supervises ESPEN which coordinates control and elimination strategiesin that region.

Through the OEPA partnership, WHO collaborates with endemic countries and international partners in the WHO Region of the Americas. Although there is no official programme to coordinate activities in the WHO Eastern Mediterranean Region, the two countries in the region collaborate on elimination activitiesand receive the support of ESPEN to achieve elimination of river blindness.

With the shift from control to elimination, large areas in Africa require mapping to assess whether transmission is active and treatment required. A sampling strategy name Onchocerciasis elimination mapping has been developed to help countries conduct those assessments and start treatment where needed.

To achieve elimination goals for onchocerciasis, an ambitious research agenda will be needed to support programme progress. Specific research needs include:

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Eye care, vision impairment and blindness: Refractive errors

October 22nd, 2024 2:40 am

WHO has taken significant steps to address the global challenge of refractive error, recognizing its widespread impact and the availability of cost-effective interventions.In 2021, at the Seventy-fourth World Health Assembly, WHO Member States endorsed the first-ever global target for refractive error in: a 40-percentage-point increase in effective coverage of refractive error by 2030. This ambitious goal acknowledges the large unmet need for care and the potential for substantial improvement through accessible interventions like spectacles.

To support Member States in the achievement of the World Health Assembly endorsed 2030 target, WHO launched the SPECS 2030 initiative in May 2024, a comprehensive approach to tackle refractive error globally. This initiative calls for coordinated global action amongst all stakeholders across 5 strategic pillars (Services, Personnel, Education, Cost and Surveillance). By focusing on these key areas, the initiative aims to address the main challenges in refractive error care, including improving access to services, developing a skilled workforce, enhancing public awareness, reducing costs, and strengthening data collection and monitoring systems. Through the SPECS 2030 initiative, WHO is working to catalyse global efforts, promote best practices, and support Member States in achieving the 2030 target, ultimately aiming to reduce vision impairment and improve quality of life for millions affected by uncorrected refractive errors worldwide.

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Eye care, vision impairment and blindness: Refractive errors

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Blindness Prevention and Control – World Health Organization (WHO)

October 22nd, 2024 2:40 am

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Onchocerciasis (river blindness) – World Health Organization (WHO)

October 22nd, 2024 2:40 am

Onchocerciasis is an eye and skin disease. Symptoms are caused by the microfilariae, which move around the human body in the subcutaneous tissue and induce intense inflammatory responses when they die. Infected people may show symptoms such as severe itching and various skin changes. Some infected people develop eye lesions which can lead to visual impairment and permanent blindness. In most cases, nodules under the skin form around the adult worms.

Onchocerciasis occurs mainly in tropical areas. More than 99% of infected people live in 31 countries in sub-Saharan Africa: Angola, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Republic of Congo, Cte dIvoire, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Ghana, Guinea, Guinea-Bissau, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Sudan, Sudan, Togo, Uganda, United Republic of Tanzania.

Onchocerciasis is also transmitted in Brazil, Venezuela (Bolivarian Republic of) and Yemen.

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Onchocerciasis (river blindness) - World Health Organization (WHO)

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Trachoma – World Health Organization (WHO)

October 22nd, 2024 2:40 am

Trachoma  World Health Organization (WHO)

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