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INSIGHTS+

Key Biosimilars Events of February 2026 
Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
3 days ago
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…
February 17, 2026
The US FDA New Drug Approvals in January 2026 
Shots:  Approval numbers were lower, but the impact remained strong the FDA cleared one new drug in January 2026 versus three in January 2025, reflecting continued innovation in areas of high unmet need  Zycubo from Sentynl Therapeutics was approved for pediatric Menkes disease, offering a targeted treatment for this rare, life-threatening genetic copper deficiency disorder  Clinical results were striking, showing…
February 10, 2026
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’…
February 3, 2026
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,…
January 22, 2026
EMA Marketing Authorization of New Drugs in December 2025   
Shots:  Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.  In December 2025, the EMA…
January 20, 2026
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…
January 16, 2026
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…
January 13, 2026
PharmaShots Q4 2025 Highlights 
Shots:  As 2025 wrapped up, the final quarter made one thing clear: biopharma is doubling down on scale, science, and speed. From October to December, the industry saw a surge in high-value M&A and strategic collaborations, with companies racing to strengthen pipelines across neuroscience, oncology, metabolic diseases, and next-generation platforms  The quarter was led by…
January 12, 2026
J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2025 (Part 01) 
Shots:    Lilly leads with precision and purpose with 45 deals totaling $21.22B in 2025, focusing on platform-driven, science-led partnerships across oncology, gene therapy, RNA editing, and AI-enabled discovery while building durable innovation engines rather than chasing short-term wins  Strategic dealmaking over sheer volume is evident in partnerships like precision oncology with Scorpion Therapeutics and CNS delivery with Sangamo, structured to…
January 8, 2026
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