Althea Technologies, Inc.
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Latest From Althea Technologies, Inc.
Public Company Edition: Direct Biologics, YishengBio and Estrella Biopharma will go public by merging with special purpose acquisition corporations. Also, Vir lands a government contract worth up to $1bn, Idorsia raises CHF164m ($167.4m) in a real estate deal and Adamis reviews alternatives.
Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.
Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.
Tipped to bring in revenues from its proposed Stelara biosimilar of $600m in 2027, Alvotech has confirmed plans for a potentially landmark filing with major regulators by the end of the year.
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