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Eli Lilly and Company Backs Haryana State FDA Action Against Counterfeit Drugs
Eli Lilly and Company supports Haryana State FDA action against counterfeit medicines, providing guidance on safe procurement and product identification to ensure patient safety and drug authenticity.
Center for Drug Evaluation accepts Bayer’s marketing authorisation application for FXIa inhibitor asundexian in stroke prevention, supported by phase 3 OCEANIC-STROKE data.
Chiesi Group to Acquire KalVista Pharmaceuticals to Expand Rare Disease Portfolio
Chiesi Group to acquire KalVista Pharmaceuticals for USD 1.9 billion, adding an oral on-demand therapy for hereditary angioedema and strengthening its global rare disease portfolio, with closing expected in Q3 2026.
Precision BioSciences Begins Patient Enrollment in Phase 1/2 FUNCTION-DMD Trial
Precision BioSciences activates its first clinical site at Arkansas Children’s Hospital and begins patient enrollment in the phase 1/2 FUNCTION-DMD trial of PBGENE-DMD for Duchenne muscular dystrophy.
Henlius and Organon Win EC Nod for POHERDY, Biosimilar to PERJETA
European Commission (EC) approves Shanghai Henlius Biotech Inc. and Organon & Co.’s POHERDY (pertuzumab), the first PERJETA biosimilar in Europe, backed by strong analytical, clinical, safety, and immunogenicity data.
Samsung Bioepis and ATLATL Sign MoU to Boost Early-Stage Biotech Innovation in Asia-Pacific
Samsung Bioepis partners with ATLATL to accelerate early-stage biotech innovation in Asia-Pacific, leveraging R&D expertise to support startups and advance breakthrough technologies.
Pfizer Reaches Three Settlement Deals for VYNDAMAX
Pfizer reaches three settlement agreements for VYNDAMAX, extending US patent exclusivity to June 1, 2031, subject to the outcome of other litigation.
Sapient’s Protein Mapping Platforms include SurfaceSeek to identify druggable tumor cell surface proteins, SignalingSeek to measure signaling pathway activation, and ImmuneSeek and ResistanceSeek to map immune and resistance biology–directly in fresh-frozen and FFPE human tumor.
Orca Bio Receives US FDA RMAT Designation for Orca-Q in Blood Cancers
Orca Bio receives US Food and Drug Administration (FDA) RMAT designation for Orca-Q in high-risk hematologic malignancies, backed by promising phase 1 data on survival and GVHD outcomes, with further results expected in 2026.
Gilead Sciences Completes Arcellx Inc. Acquisition Ahead of Anito-cel Launch
Under the terms of the transaction, Gilead acquired Arcellx for USD 115 per share in cash, plus one non?transferable Contingent Value Right (CVR) of USD 5 per share, representing a total implied equity value of approximately USD 7.8 billion at the time of closing.
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