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Latest From Janssen Pharmaceuticals Inc.

How Accumulus’s ‘Dossier In The Cloud’ Platform Is Modernizing ‘Inefficient’ Drug Regulation

Global non-profit Accumulus Synergy wants to remove “unnecessary complexities and inefficiencies” in the regulatory process with its cloud-based communication platform, the corporation’s CEO and chief regulatory innovation officer tell the Pink Sheet.

BioPharmaceutical Europe

Keeping Track Of AdComms: US FDA Puts Donanemab On Schedule, Delays COVID-19 Meeting

Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

US FDA Performance Tracker Advisory Committees

Janssen’s Stelara May Be Medicare Price Negotiation Savings Star

New research is gauging how much savings CMS may see on the prices of the first 10 drugs selected for negotiation.

Reimbursement Medicare

Cidara Offloads Rezzayo, Will Focus On Universal Flu Preventative

Cidara conferred global rights to its novel antifungal to marketing partner, Mundipharma, while reacquiring a flu prophylaxis it licensed to J&J in 2021 and gaining $240m in new funding to back development.

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