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- PMLiVE

pediatrics

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Pfizer and Arvinas announce $1bn deal for investigational oral protein degrader

ARV-471 is currently in a phase 2 trial for the treatment of patients ER-positive, HER2-negative locally advanced or metastatic breast cancer

- 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

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The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

Powerful therapies that can improve skin clarity dominate the psoriasis landscape, so why are most patients stuck in a cycle of ineffective topicals? Fishawack Health explores the market and reveals how life...

Avalere Health

- 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

Biogen pays InnoCare $125m upfront for potential multiple sclerosis treatment

Orelabrutinib is currently being evaluated in a phase 2 trial in relapsing-remitting MS

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FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

AbbVie, Biogen and Pfizer collaboration creates new resource for genetic exome sequence analysis

Companies have created 'world’s largest' resource for genetic exome sequence analysis

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

Israel study suggests Pfizer/BioNTech vaccine is less effective against Delta variant

Data suggests vaccine is 64% effective at preventing infection caused by Delta variant after two doses

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

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

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