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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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2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe 

Shots:  EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion  Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…

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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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Samsung Bioepis

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…

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The 2025 Playbook: Industry Trends Shaping the Future of Biopharma 

Shots:  2025 marked a decisive inflection point for the global life sciences and biopharma industry. After several years defined by experimentation, abundant capital, and expansive innovation narratives, the industry entered a phase of disciplined execution.   Strategies were stress-tested, science was closely scrutinized, and only programs with clear biological rationale and operational readiness advanced.  Rather than…

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Evorpacept’s Momentum in HER2+ Gastric Cancer: A Conversation with Jason Lettmann from ALX Oncology 

Shots:  Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells  Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…

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Optimizing Life Sciences CRM: A Candid Conversation with Akshay Kapadia from Conexus Solutions 

Shots:  As life sciences organizations increasingly adopt integrated data, AI, and advanced analytics, CRM platforms are becoming powerful tools to anticipate customer needs, personalize engagements, and measure impact in real-time across multiple channels    In the coming years, CRM will transform into a strategic intelligence hub, empowering teams to make data-driven decisions and helping companies…

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Post Conference Highlights: Peptides & Complex Generics Symposium 2025

Day 1 Breakdown The #PCG2025 Symposium commenced on an inspiring note, setting the stage for two days of insightful discussions, collaborations, and knowledge exchange. Opening Session Dr. Ratnesh Jain, Founder & Director, Mumbai Cluster, delivered the inaugural address, sharing his vision of bringing together pharma professionals, R&D experts, CXOs, and academicians to accelerate advancements in…

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The Rise of Industrial Metaverse: Smarter Pharma Starts at AUTOMA+ 2025 

Digital transformation of the pharmaceutical industry is moving beyond buzzwords to real-world impact. At the Pharmaceutical Automation & Digitalisation Congress AUTOMA+ 2025 (24-25 November, Vösendorf, Austria), pharma leaders, including ZETA GmbH, Takeda and Sapio Sciences, are going to showcase how cutting-edge technologies, from digital twins and predictive analytics to minimal code platforms and AI-driven process…

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