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Latest From UCB S.A.

Leaner Kabi Drives Higher Savings Goal For Fresenius, China ‘Soft’ In 2024

Fresenius Kabi insists there is a “business plan behind everything” as it divulged a higher cost savings goal for the end of next year, following a fruitful 2023. But queries over margins led the company to stress that it was combatting a variety of uncertainties, especially in China and for its burgeoning biosimilars unit.

Sales & Earnings Strategy

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance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

Orphan Drug, Domestic Developers Shine In China Annual Approvals Tally

10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions.

China Approvals

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.

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