Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025 Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…

ByRidhi Rastogi8 hours ago

NEWS

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

ByRidhi RastogiJuly 23, 2025

NEWS

JCR Pharmaceuticals Collaborates with Acumen Pharmaceuticals to Develop Novel Alzheimer’s Therapies

Shots: JCR & Acumen have entered into a joint collaboration, option, & license agreement to develop a novel therapy to treat Alzheimer’s disease leveraging JCR’s J-Brain Cargo tech As per the deal, JCR will receive an upfront payment & an option payment if Acumen exercises its exclusive option to develop, manufacture, & commercialize up to…

ByRidhi RastogiJuly 16, 2025

NEWS

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Shots: Cognition has reported topline P-II (MAGNIFY/COG2201) trial data assessing zervimesine (200mg, QD, PO) vs PBO in adults with GA secondary to dry AMD; trial concluded after enrolling ~100 of 246 planned subjects In the trial, nearly 2/3 pts completed 12mos. & 1/3 completed 18mos. of dosing, showing a 28.6% slower GA progression & ~12%,…

ByRidhi RastogiMay 9, 2025

NEWS

Veravas Launches VeraBIND Tau to Detect Alzheimer’s Disease & other Tauopathies

Shots: Veravas has launched VeraBIND Tau to detect both symptomatic & pre-symptomatic pts with Alzheimer's disease (AD) or other tau-related neurodegenerative disorders (tauopathies) In an analytical verification study, VeraBIND Tau showed 96% sensitivity, 90% specificity, & 92% agreement with tau PET imaging, detecting Alzheimer’s-related tau & offering VeraBIND Tau score, a semi-quantitative measure of pathologically…

ByRidhi RastogiApril 23, 2025

NEWS

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Shots: The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA states Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…

ByRidhi RastogiApril 16, 2025

VIEWPOINTS

Enhancing Neurodegenerative Care: Stella Sarraf from Spinogenix in an Enlightening Dialogue Exchange with PharmaShots

Shots: With a broad portfolio of candidates in ALS, Alzheimer’s disease, Schizophrenia, and Fragile X Syndrome, Spinogenix initiated the P-II study evaluating SPG302 for the treatment of patients with Alzheimer’s disease SPG302, a synaptic regenerative therapy, is aimed to provide an effective and patient-friendly solution as a daily pill for ALS and Alzheimer’s disease Today…

BySaurabh ChaubeyOctober 14, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2024 The US FDA approved a total of 2 new drugs including 1 new molecular entity and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Eli Lilly’s Kisunla for…

ByDipanshu DixitAugust 13, 2024

NEWS

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease

Shots: The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer's disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) &…

ByDipanshu DixitJuly 2, 2024

VIEWPOINTS

Michael Irizarry, SVP, Clinical Research, Eisai Shared Insights on P-III Results from Clarity AD Study

Shots: Michael spoke about the P-III Clarity AD study evaluating Leqembi (lecanemab) for the treatment of mild cognitive impairment due to Alzheimer’s disease presented at CTAD 2022 He also talked about Eisai’s collaboration with Biogen for the co-commercialization and co-promotion of Lecanemab The interview gives an understanding of how Biogen develops and delivers innovative therapies…

BySenior EditorJuly 4, 2023

Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

JCR Pharmaceuticals Collaborates with Acumen Pharmaceuticals to Develop Novel Alzheimer’s Therapies

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Veravas Launches VeraBIND Tau to Detect Alzheimer’s Disease & other Tauopathies

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Enhancing Neurodegenerative Care: Stella Sarraf from Spinogenix in an Enlightening Dialogue Exchange with PharmaShots

Insights+: The US FDA New Drug Approvals in July 2024

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease

Michael Irizarry, SVP, Clinical Research, Eisai Shared Insights on P-III Results from Clarity AD Study

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