INSIGHTS+

PharmaShots Quarterly Outlook: The Forces Reshaping Biopharma in Q1 2026

Headlines, Trends, and the Signals Shaping the Future of Biopharma A Quarter That Reset the Biopharma Narrative The first quarter of 2026 did not simply continue the momentum of the global biopharmaceutical industry; it redefined its direction. From multi-billion-dollar acquisitions and accelerating rare disease breakthroughs to AI-powered discovery collaborations and gene therapy approvals, the industry demonstrated a clear shift toward precision innovation, strategic consolidation, and next-generation…

4 days ago

EMA Marketing Authorization of New Drugs in February 2026

Shots: The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…

March 17, 2026

The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

March 10, 2026

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,…

March 3, 2026

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