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INSIGHTS+

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…
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…
Key Biosimilars Events of December 2025  
Shots:        Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications  Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon,…
2025 Drug Approvals Outlook: A Year of Precision Across Therapeutic Frontiers 
Shots: Precision, convenience, and disease modification define 2025 drug approvals as regulators reward biologically clear, patient-specific therapies that fragment legacy markets, elevate rare diseases, and prioritize meaningful outcomes over broad labels. Innovation is shifting from complexity to usability with oral, subcutaneous, topical, and on-demand therapies improving access and adherence across neurology, cardiology, endocrinology, ophthalmology, and…
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…
Know Your Investor: ARCH Venture Partners (December’25 Edition) 
Shots:  ARCH Venture Partners is a leading US-based venture capital firm recognized for backing bold science and building category-defining companies across biotechnology, life sciences, and transformational healthcare, with a strong focus on company creation  In 2024, ARCH completed 31 investments from Seed to Series A–F and beyond, including late-stage and private rounds. The firm backed innovators such…
Disease of the Month – Hemolytic uremic syndrome 
Shots:  Hemolytic uremic syndrome (HUS) is a serious, potentially life-threatening condition in which damage to the small blood vessels in the kidneys interferes with their ability to function properly  With the Disease of Month report, we break down complex medical topics into clear, meaningful insights for global readers. By highlighting conditions that impact communities worldwide, we aim to keep our readers informed,…
New Drug Designations – November 2025  
Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The November 2025 report covers designations granted to 22 drugs and 1 medical device, spanning 8 small molecules, 8 biologics, 2 cell and gene therapies & 1 medical…
EMA Marketing Authorization of New Drugs in November 2025  
Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…
The US FDA New Drug Approvals in November 2025 
Shots:  Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more  The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress  November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…