The first biopharmaceutical, human insulin, was approved for use in 1982 (1). The biopharmaceutical market continues to exhibit healthy growth now, with the number of yearly patent applications increasing by 25% annually since 1995 (2). The total pharmaceutical R&D pipeline has more than doubled since the beginning of the century (Figure 1), much of that attributable to the biologics industry segment. As this industry has matured, new platform methods have emerged, and competition has increased. Consequently, the pressures of speed,…
Wednesday, December 5, 2018 Daily Archives
J&J and Merck team with UK gov on $97m vaccine manufacturing center
The UK government-led Vaccines Manufacturing Innovation Centre will have pilot and medium-scale capacity and the ability to respond to threats of serious infections. The center, to be built in Oxford, UK will focus on the production of vaccines for outbreaks of diseases such as Ebola and Lassa fever, bridging the gap between academia and industry. The project has been funded by the UK government’ Industrial Strategy, a business-backing program from the Department for Business, Energy & Industrial Strategy aimed at…
Gilead hopeful for allogeneic IND next year
Gilead, which has already seen success with an autologous CAR-T therapy, says it hopes to submit an Investigational New Drug (IND) request for an off-the-shelf product in 2019. In August 2017, Gilead Sciences acquired Kite Pharma for $11.9 billion (€10.5 billion). Weeks later, the firm became only the second to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy through the Kite-developed product Yescarta (axicabtagene ciloleucel). Yescarta is an autologous product, meaning it…