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US FDA Grants Orphan Drug Designation to CK0804 Treg Therapy of Cellenkos
The US FDA has granted Orphan Drug Designation to Cellenkos’ CK0804, a first-in-class CXCR4hi Treg therapy for myelofibrosis. The investigational therapy is designed to home to the bone marrow and spleen, where it modulates inflammation through in-vivo expansion and IL-10 secretion.
Atossa Therapeutics Receives FDA Go-Ahead for (Z)-Endoxifen IND in Metastatic Breast Cancer
Atossa Therapeutics announced that it has received a “Study May Proceed” letter from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for (Z)-endoxifen in metastatic breast cancer, clearing the way for the initiation of clinical studies evaluating the therapy.
Amgen Acquires UK- based Dark Blue Therapeutics in 840M USD Deal
Amgen’s acquisition of Dark Blue Therapeutics, adds a first-in-class protein degrader programme targeting MLLT1/3-driven acute myeloid leukemia to strengthen its early-stage oncology pipeline.<br />
Lilly in Advanced Talks to Acquire Ventyx Biosciences in Deal Worth Over USD 1 Billion
Eli Lilly & Company is in advanced discussions to acquire Ventyx Biosciences in a deal valued at more than USD 1 billion, according to reports citing people familiar with the matter. The acquisition talks have attracted strong investor interest, with Ventyx shares rising sharply following the news.
China Updates Ivonescimab Label After NSCLC Survival Gains
China’s drug regulator has approved a label update for Akeso’s ivonescimab, citing Phase III data showing significant improvements in progression-free and overall survival in EGFR-TKI-resistant non-small cell lung cancer patients.<br />
Esco Aster Signs cGMP Exosome Manufacturing Deal with Shine-On Biomedical
Esco Aster has entered into a clinical cGMP manufacturing agreement with Shine-On Biomedical to support the production of a first-in-class HLA-G–targeting exosome drug delivery platform, while also providing technical services for exploratory exosome loading feasibility studies to advance the programme’s development.
Japan Approves Exdensur for Severe Asthma and Nasal Polyps
Japan has approved Exdensur (depemokimab) for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first ultra-long-acting biologic in the country, with approval supported by phase-III SWIFT and ANCHOR trial data demonstrating sustained efficacy with twice-yearly dosing.
WuXi Biologics, a global contract research, development and manufacturing organisation (CRDMO), has achieved ISO 20400 Sustainable Procurement certification, a globally recognised standard that embeds sustainability principles into procurement practices and promotes transparency, accountability and responsible supply chain management.
Pandorum Partners with Nucelion Therapeutics to Manufacture Exosome-Based Ocular Therapy for APAC
Pandorum Technologies, a clinical-stage regenerative medicine company, has entered into a strategic manufacturing collaboration with Nucelion Therapeutics, the contract research, development and manufacturing organisation (CRDMO) arm of Bharat Biotech, to support the production of its exosome-based ocular disease therapy for the Asia-Pacific (APAC).
PHARMEXCIL Engages Government Leaders to Strengthen Indian Pharmaceutical Export Growth
The Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) held a series of high-level discussions with key government stakeholders to align policy priorities, accelerate export momentum and reinforce India’s position in global pharmaceutical markets.
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