US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.

A potential next-generation, 24-valent, pneumococcal vaccine in development by Affinivax and Astellas has shown strong immunogenicity in a Phase II study and is preparing to enter pivotal Phase III trials; if successful, it will target a growing market currently dominated by big pharma players.

Private Company Edition: Venture capital mega-rounds continue a brisk pace with machine learning-based drug discovery firm insitro and gene therapy developer Graphite Bio among recent $100m-plus deals. Also, Argobio raised €50m to fund five start-ups in Europe. 

Private Company Edition: The pre-J.P. Morgan Healthcare Conference financing news deluge during the first week of 2021 included several significant venture capital deals, including a $226m series B round for Affinivax, Ikena’s $120m series B round and an $88m series A round for Aro.