Biogen’s wet AMD drug receives US FDA nod posing competition to Roche’s Lucentis

USA – Biogen Inc together with Samsung Bioepis Company Limited have announced that the USFDA has granted their neovascular age-related macular degeneration (wet AMD) drug, Ranibizumab, approval for use against macular edema. This drug will be in competition with Lucentis, Roche’s blockbuster drug which was approved in 2006 and has accumulated sales of over US$1.61 billion in U.S. this past year. FDA’s approval is another win for Biogen, which in the recent months has been hitting headlines due to its controversial yet trendsetting Alzheimer’s drug Aduhelm. Ranibizumab is an anti-vascular…

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

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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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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Biogen provide clarity amid controversies surrounding its FDA approved drug Aduhelm

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

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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Biogen signs collaborative agreement with Innocare to use orelabrutinib as potential therapy for multiple sclerosis

WORLD – Biogen and Innocare, a biopharmaceutical company rooted in China, have signed a license and a collaboration agreement for the use of Orelabrutinib that could potentially be used to treat multiple sclerosis. Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China, while Innocare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China. InnoCare will receive a US$125M upfront payment and is eligible to…

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

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

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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FDA grants approval for ADUHELM as the first and only Alzheimer’s disease treatment

USA – U.S. Food and Drug Administration has approved Biogens’ Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans, the first new treatment approved for Alzheimer’s since 2003. Aduhelm has been approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Currently available therapies only treat symptoms of the disease whereas this treatment option is the first therapy to target and affect the underlying disease process of…

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