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EMA Marketing Authorization of New Drugs in January 2026    

Shots:  The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka.  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock.  Decisions were backed by strong Phase II/III data…

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Memo Therapeutics and CSL Partner to Advance Recombinant Polyclonal IgG Technology

Shots: Memo has entered into a strategic collaboration & exclusive option-to-license agreement with CSL for Memo’s recombinant polyclonal IgG technology As per the deal, Memo will use its Dropzylla platform for cloning human antibody repertoires & polyclonal antibody expression to develop recombinant polyclonal IgG products, while CSL will obtain an option to exclusively license those…

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Innovent and Eli Lilly Strike ~$8.85B ex-China Collaboration to Accelerate Oncology & Immunology Programs

Shots: Innovent & Eli Lilly have entered into a strategic collaboration to advance novel medicines in oncology & immunology As per the deal, Innovent will advance the programs from discovery through P-II PoC trial in China using its antibody platforms, while Lilly will receive exclusive rights to develop & commercialize the assets globally, excl. Greater…

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Key Biosimilars Events of January 2026   

Shots:  Global biosimilar activity accelerated across ophthalmology, oncology, immunology, and diabetes, with new or advancing alternatives to Lucentis, Eylea, Stelara, Lantus, Avastin, Opdivo, and Neulasta, expanding patient access across Europe, the US, India, Canada, Ghana, and MENA  Regulatory and commercialization momentum remained strong, marked by FDA, EC, Health Canada, and Ghana FDA milestones, alongside Samsung Bioepis’…

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Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand

Shots: Alvotech has entered into supply & commercialization agreements with Sandoz for multiple biosimilar candidates across Canada, Australia, & New Zealand In Canada, the deal includes one ophthalmology biosimilar in a prefilled intravitreal syringe, while in Australia & New Zealand, it covers 3 biosimilar candidates across immunology & gastroenterology in multiple formulations As per the…

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MS Pharma enters an exclusive biosimilar partnership with Hetero 

Shots:  MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region  The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group  This marks Hetero’s first local partnership in Algeria, supporting…

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GSK to Acquire RAPT Therapeutics for ~$2.2B

Shots: GSK has entered into a definitive agreement to acquire RAPT Therapeutics, incl. its P-II asset ozureprubart with data expected in 2027, strengthening GSK’s inflammatory & immunology pipeline As per the deal, GSK will acquire RAPT for $58/share, representing the aggregate equity value of $2.2B & an estimated upfront investment of $1.9B cash; closing expected…

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J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2025 (Part 02)  

Shots:  Novartis led biopharma dealmaking in 2025, executing 23 transactions worth $37.92B with a disciplined, high-impact strategy that balanced scale, science, and strategic fit    Dealmaking was spread across high-conviction areas; neuroscience, cardiovascular disease, immunology, and RNA platforms, combining transformational acquisitions with flexible licensing partnerships to build a future-ready pipeline    Standout transactions (Avidity, Monte…

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The US FDA New Drug Approvals in December 2025 

Shots:  Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision  Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…

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