Tag: Alzheimer’s Disease

Uganda battles rising cases of Dementia despite heavy funding constraints

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UGANDA – A prevalence study conducted in Uganda ha shown that one in five people in Uganda aged 60 and above, has Alzheimer’s disease or related forms of dementia, raising alarm in the country. The findings of this study support World Health Organisation’s latest data, which shows that two-thirds of people with dementia worldwide live in low and middle-income countries. Alzheimer’s is a disorder that causes the brain to shrink and brain cells to die, slowly destroying memory and thinking skills, and eventually the ability to carry out activities of…

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Biogen offers free Alzheimer’s drug as Medicare payment uncertainty remains

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USA – Biogen is providing its controversial and expensive new Alzheimer’s drug free of charge for some patients amid slow claim reviews by Medicare, according to sources familiar with the situation. The development underscores the division among doctors about whether the $56,000-a-year drug helps patients and how uncertainty about reimbursement from Medicare, the U.S. government health plan for people over age 65, has held back prescriptions and sales. Aduhelm, which is given as a monthly infusion, was approved by the U.S. Food and Drug Administration in June even though one…

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Eli Lilly to seek FDA’s approval for Alzheimer’s drug as competition for Biogens’ Aduhelm

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USA – Eli Lilly and Co has announced its plans to seek U.S. approval for its experimental Alzheimer’s disease drug by year end and believes the treatment could be favored by doctors once it becomes available to patients. A landmark U.S. approval of Biogen Inc’s Alzheimer’s drug in June has boosted the chances for other medicines that clear plaques from the brain. Several companies including Lilly have been hoping to bring similar drugs to market. Eli Lilly said mid-stage data it plans to submit to regulators for its donanemab showed…

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Biogen provide clarity amid controversies surrounding its FDA approved drug Aduhelm

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US – Aduhelm’s approval has been the subject of extensive misinformation and misunderstanding as experts believed data from the first and second phase were not as exemplary as the third phase trials. The approval of Aduhelm by the U.S. Food and Drug Administration (FDA) came after an extensive development, testing and review process hence granting Biogen an accelerated approval. Biogen has stated that it is open to formal review and interactions between the FDA, members of the public and other concerned relevant authorities. Accelerated approval by the FDA The FDA…

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FDA’s approval of aduhelm drug marred by controversy following resignations by three FDA panel members

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US – Aduhelm was the first of its kind drug for Alzheimer’s disease to be approved in two decades under the accelerated approval by Food & Drug Association (FDA), however, post its approval period the drug was met with a lot of back lash as many experts were dubious about its functionality. Its approval by the FDA saw three panel members of the association exit and one among the three members, Dr Aaron Kesselheim of Harvard-affiliated Brigham and women’s hospital, wrote in his resignation letter that the drug was among…

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Alzheimer’s disease gaining recognition as researchers and pharma companies work to find therapy

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WORLD– According to World Health Organization (WHO), Alzheimer’s disease attributes to around 60-70 % cases of dementia cases globally. WHO projects that by the year 2030, 82 million cases of Dementia will be recorded which will nearly double by the year 2050 hence more cost of treatment which currently stands at US$818Bper annum, equivalent to 1.1% of global gross domestic product (GDP). The disease currently has no cure and has prompted researchers and pharma-based companies to work a way on how to develop its therapy as also a measure to…

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UK based biotech start-up Kuano raises US$1.38M to venture into Artificial Intelligence-driven drug discovery

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UK – Kuano, a UK-based startup that deals in Artificial Intelligence, has raised £1M in seed funding to further expedite the development of its platform for the discovery of therapeutics meant to target enzyme inhibition. The £1 million in funding will go towards expanding the technology team and the further development of the company’s platform and assets, including its own range of novel therapeutics. It will also be used to create a data bank for use in its work with academic and commercial partners. Kuano’s software platform creates rapid, cost…

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Lilly’s donanemab receives U.S. FDA’s Breakthrough Therapy designation for treatment of Alzheimer’s disease

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USA – The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s investigational antibody therapy for Alzheimer’s disease (AD). The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval. The FDA Breakthrough Therapy designation is based on clinical evidence for donanemab, an investigational antibody…

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GE healthcare showcase their new innovations at the Society of Nuclear Medicine and Molecular Imaging’s (SNMMI) 2021 summer conference

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US – GE Healthcare showcased a new molecular imaging products and solutions as well as new opportunities to expand access to radioactive tracers and other pharmaceutical imaging agents during the SNMMI 2021 summer conference. This increase in access to the latest and most innovative precision diagnostics and radiopharmaceuticals, particularly with recent FDA clearances of critical new therapies, can provide clinicians unique opportunities to make personalized care decisions and treatment response assessments that may help improve patient outcomes. As an example, GE Healthcare is doubling its U.S. distribution footprint of Vizamyl…

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Controversy surrounding Biogen’s newly approved Alzheimer’s drug costs FDA one more panelist

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USA – A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said in his resignation letter that the agency’s decision on Biogen is probably the worst drug approval decision in recent U.S. history. “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to…

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