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- PMLiVE

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- PMLiVE

Lilly restructures in preparation for Alzheimer’s drug launch

As excitement builds around its potential Alzheimer’s drug, donanemab, Lilly has created a new neuroscience business unit, Lilly Neuroscience, to shepherd the company’s portfolio in pain and neurodegeneration

- PMLiVE

Lilly restructures in preparation for Alzheimer’s drug launch

As excitement builds around its potential Alzheimer’s drug, donanemab, Lilly has created a new neuroscience business unit, Lilly Neuroscience, to shepherd the company’s portfolio in pain and neurodegeneration

- PMLiVE

First oral antiviral drug for COVID-19 reviewed by Health Canada

Early phase 2/3 data including early safety, quality and efficacy data for Merck’s molnupiravir will be reviewed by the regulator while the study is still underway

- PMLiVE

Merck spin-off Organon sees share price jump at Q2 results

Strong growth in women’s health and biosimilars is driving the new company, which expects 2021 growth in the “low to mid-single digit range”

- PMLiVE

Biogen and Eisai present new data for controversial Alzheimer’s drug Aduhelm at AAIC

The data showed that high-dose Aduhelm treatment demonstrated consistent effects as measured by the Clinical Dementia Rating-Sum of Boxes

- PMLiVE

Roche engaged in talks with FDA for Alzheimer’s drug candidate

CEO Severin Schwan told reporters Roche will complete a phase 3 trial of gantenerumab in the second half of 2022

- PMLiVE

Lilly and Banner Alzheimer’s Institute collaborate on donanemab prevention trial

Trial will evaluate donanemab in participants at risk for cognitive and functional decline related to Alzheimer’s

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

Biogen Idec building

FDA narrows label for Biogen’s Aduhelm to only include mild forms of Alzheimer’s disease

Reflects the patient population included in clinical trials of anti-amyloid treatment

- PMLiVE

GlaxoSmithKline agrees $2.2bn dementia mAb deal with Alector

The focus of the deal is two clinical-stage monoclonal antibodies in development for a number of neurodegenerative diseases

Biogen Idec building

ICER says price of Biogen’s Aduhelm should be much lower

US cost-effectiveness watchdog’s analysis estimates current annual list price of $56,000 could be reduced to $3,000 to $8,400

- PMLiVE

Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

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