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Latest From Veru Inc.

‘The Pandemic Is Over’? Not For US FDA

President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.

Coronavirus COVID-19 Review Pathway

Coronavirus Notebook: Veru’s Sabizabulin Prioritized By European & US Regulators, Kinarus’s KIN001 Offers ‘Synergistic Efficacy’

Sabizabulin is the first product to be assessed under the European Medicines Agency’s expanded mandate, and has also been filed for a US emergency use authorization. At global level, the World Health Organization has issued new guidance on the use of second booster doses of COVID-19 vaccines.

Europe United Kingdom

Afrigen MD: WTO IP Waiver Important From ‘Freedom To Operate’ Standpoint

Afrigen’s MD, Petro Terblanche, discusses the operational freedom that the WTO intellectual property waiver provides for its COVID-19 vaccine being developed under the wider WHO-backed mRNA technology transfer hub initiative. The executive doesn’t anticipate big pharma pushback but says the alliance will “test the system”, though others believe the waiver in its current form doesn’t count for much.

Commercial Coronavirus COVID-19

Finance Watch: DRI Healthcare’s Canadian IPO Enables More Royalty Deals

Public Company Edition: US initial public offerings are reawakening from a brief nap as Prometheus and Longboard prepare IPOs for launch. Also, Halozyme sells $700m worth of notes and Karuna’s $250m stock sale leads recent follow-on offerings.

Financing Growth
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    • Aspen Park Pharmaceuticals
    • The Female Health Company
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