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Celera Group

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Latest From Celera Group

Sandoz Enters Canada With First Denosumab Biosimilar

Sandoz has truly established its position as the frontrunner in the denosumab race after a Canadian approval, but the path to the US market has been hindered by a lawsuit from the originator Amgen.

Biosimilars Approvals

A Myrbetriq Battle Is Brewing And Why It Matters

Zydus and Lupin are gearing up for the US launch of a generic to Astellas Pharma’s blockbuster drug Myrbetriq (mirabegron) while Aurobindo expects a longer wait. Meanwhile, Torrent is preparing to defend its market share in chronic therapies in India as other companies increasingly target this segment

Business Strategies Commercial

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance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