USA – Eli Lilly has pushed back the deadline for submitting an application for U.S. approval of its experimental Alzheimer’s disease drug, revealing that it will now complete the filing…
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Takeda, Denali’s Alzheimer’s candidate drug hits regulatory drawback
USA – The FDA has placed a clinical hold on Denali Therapeutics’ Alzheimer’s drug before it even enters human trials. The decision has an impact on Takeda, which only recently…
Read MoreBecerra tells Medicare to review premiums after Aduhelm cost cut
USA – U.S. Health Secretary Xavier Becerra has directed the Centers for Medicare & Medicaid Services (CMS) to reconsider a hefty 2022 Medicare Part B premium hike proposal based in…
Read MoreBiogen mulls massive layoffs following disappointing Aduhelm rollout: Report
USA – Biogen is planning to lay off over 1000 employees following the disappointing launch of its Alzheimer’s therapy Aduhelm (aducanumab), according to STAT News. According to STAT News, Biogen…
Read MoreFirst nasal vaccine against Alzheimer’s disease enters human trial phase
USA – Clinical trial for Alzheimer’s disease (AD) nasal vaccine has been launched to see whether a potential treatment could be safe for humans after the therapy showed positive results…
Read MoreBiogen’s Alzheimer’s drug gets negative vote from European regulators
EUROPE – European Medicines Agency (EMA) panel voted against approval of Biogen Inc’s Alzheimer’s drug Aduhelm, dealing another setback to the treatment already grappling with a slow rollout in the…
Read MoreBiogen’s pricey Alzheimer’s drug spurs biggest increase in Medicare premium
USA – The federal government has announced a significant increase in Medicare premiums, blaming the pandemic but also citing “uncertainty” about how much it may be forced to pay for…
Read MoreAduhelm 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…
Read MoreFDA’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,…
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