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Eli Lilly to Acquire Merida Biosciences for ~$2.875B

Shots: Eli Lilly has entered into a definitive agreement to acquire Merida Biosciences incl. its antibody-engineering platform & programs, strengthening Lilly's immunology capabilities As per the deal, Eli Lilly will acquire Merida Biosciences for $2.875B in cash, incl. an upfront payment, & contingent milestone payments; closing is expected in the Q4’26 Merida’s lead program, MER511,…

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Zambon Secures the EC Approval for Hopledo to Treat Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The EC has approved Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Approval was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…

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Gilead

Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Shots: The US FDA has approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg) for the treatment of HIV in adults who are virologically suppressed Approval was based on the P-III (ARTISTRY-1 & ARTISTRY-2) trials, assessing Bixlenvo (QD, PO) in adults with HIV who are virologically suppressed, incl. those who switched from complex multi-tablet regimens or from Biktarvy In…

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DualityBio Inks $1B+ Deal with Genentech to Develop Next-Generation ADCs 

Shots: DUALITYBIO has entered into a collaboration & license agreement with Genentech to develop next-generation ADCs, leveraging DUALITYBIO’s DUPAC (DualityBio Unique Payload Antibody Conjugate) platform DualityBio will discover & develop ADCs against Genentech-selected oncology targets using DUPAC payloads, leading discovery & early global development, while Genentech will secure exclusive global rights & take over development…

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SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted Fast Track Designation (FTD) to SOT106 for the treatment of soft tissue sarcoma SOT106 is an ADC that targets LRRC15, a clinically validated target broadly expressed across multiple prevalent sarcoma subtypes, & has received FDA Orphan Drug Designation for osteosarcoma treatment SOTIO plans to initiate a first-in-human clinical trial of SOT106…

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Samsung Bioepis

Samsung Bioepis Begins P-I Trial of SB35 (Biosimilar, Taltz)

Shots:  Samsung Bioepis Initiates Phase 1 Trial of SB35 (ixekizumab), a Biosimilar version of Taltz   The P-I randomized, double-blind study will compare single-dose SB35 and Taltz in healthy participants for PK, safety, tolerability, and immunogenicity. Participants will be randomized 1:1, with 1EP including AUCinf, Cmax, and AUClast through Day 85  Ixekizumab is a humanized IgG4 mAb that selectively binds to IL-17A, blocking IL-17 receptor signaling and reducing…

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