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Zydus to Acquire Assertio in ~$166.4M All-Cash Deal

Shots: Assertio Holdings’ Board has approved a definitive agreement with Zydus Worldwide DMCC, a subsidiary of Zydus, to acquire all outstanding Assertio shares, delisting it from the Nasdaq Assertio’s Board determined Zydus’ proposal constituted a “Superior Proposal” under the Garda merger agreement & authorized termination of the Garda transaction As per the deal, Zydus will…

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Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT Trial showed a…

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BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…

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Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

Shots: Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…

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Boehringer Ingelheim Inks ~$ 479.6M Deal with Immunitas Therapeutics for a Preclinical Antibody Program

Shots: BI has entered into a global licensing agreement with Immunitas for a preclinical antibody program being developed for chronic inflammatory & autoimmune diseases As per the deal, BI will obtain global rights to develop, manufacture, & commercialize the antibody program in exchange for an upfront payment, up to €407.5M (~$479.6M) in development, regulatory, &…

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