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Celera Group

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Latest From Celera Group

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance

Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.

Drug Approval Standards Clinical Trials

The ‘Biggest’ Dealmakers Of 2023 Were Not The Busiest

Eli Lilly, striving to outpace Novo Nordisk, dominated the dealmaking scene in 2023 by executing six acquisitions. Although Pfizer, BMS and AbbVie sealed the largest M&A deals of the year, they did not lead in terms of volume.

Deals M & A

From COVID Cliff To GLP-1 Ramp: Novo Takes Catalent Plants For Next Public Health Crisis

A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.

Manufacturing Supply Chain

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Advisory Committees Rare Diseases
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