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Daiichi Sankyo will expand its production site in Pfaffenhofen, Germany with new R&D capability for antibody-drug conjugates, spending €1bn. Behind the major new investment, the firm has recently filed for the approval of two ADCs in the US and is preparing global approval filings including in Europe and Asia.
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.
After sales of the RET inhibitor have been commercially disappointing, Blueprint said it is selling US rights to the drug to Rigel for $15m up front and potentially more than $100m in milestones.
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
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