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Allergan, Inc.

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Tarsus Demonstrates Lotilaner’s Potential In Preventing Lyme Disease

Lotilaner, the active ingredient in Tarsus’s Demodex blepharitis drug Xdemvy, showed significant ability to kill ticks in a small Phase IIa study. Analysts call the Lyme program a likely out-licensing opportunity for Tarsus.

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Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance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

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For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

Drug Approval Standards Guidance Documents

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.

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