LONDON – Andrew Witty, CEO of GlaxoSmithKline plc and president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), hit out at austerity-driven pricing and reimbursement policies in an open letter to European heads of state delivered on Monday. Read More
LONDON – A newly identified link between a crucial developmental signaling pathway and regulation of the enzyme telomerase could one day lead to new therapies to treat cancer and degenerative diseases. Read More
New data from an open-label Phase II extension study prompted Ablynx NV to claim Monday that its tumor necrosis factor-alpha (TNF-alpha) inhibitor ozoralizumab (ATN-103) was back in the game. Read More
BOSTON – Microbial and mammalian cell lines currently dominate in the manufacturing of biologics, but novel techniques, including insect cell, plant cell and cell-free expression systems are coming through, and now are poised to present new options for companies embarking on process development. Read More
BOSTON – The wave of consolidation that has swept through the pharmaceutical sector has reduced the number of potential buyers for a biotech at the same time as a closed initial public offering (IPO) window has made mergers and acquisitions (M&A) the only possible exit. Read More
• Gentium SpA, of Villa Guardia, Italy, said it submitted its responses to the Day 180 list of outstanding issues received from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding its application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Read More