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Latest From BASF AG

FDA’s New PSG Batch Features GSK’s Inhalers

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

United States Guidance Documents

Two Avian Flu Vaccines Among 10 New Products To Get EMA Nod

The European Medicines Agency has OKd two new H5N1 jabs, including a pandemic preparedness vaccine intended for use only if a flu pandemic is declared. Eight other products are also heading for EU-wide approval.

Europe Approvals

Finance Watch: Frontier Raises $80m For Differentiated KRAS G12C Program

Private Company Edition: With its lead program in the clinic, Frontier’s $80m series C round will fund trials for additional programs. Also, ORI raises $260m for second fund, Earlybird closed a €173m ($187.1m) fund, Areteia’s series A grew to $425m and Sudo’s series B increased to $147m.

Financing Innovation

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance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