"We're quite interested in things that would augment cellular therapy. We're going to take some time to look at our own portfolio and determine what, if any other things, we should do."
John Milligan, president and CEO of Gilead Sciences Inc., on its acquisition of Kite Pharma Inc., whose most advanced candidate, the CAR T therapy axicabtagene ciloleucel (axi-cel, previously KTE-C19), is under priority review by the FDA with a PDUFA date of Nov. 29
"You could see from the financials on this deal that it's a very robust package. We've got a lot of things that we want to do with both of [our] lead assets, and this funding allows us to do that and, at the same time, more broadly strengthens the balance sheet."
Mark Enyedy, CEO, Immunogen Inc., on an option deal for earlier-stage ADCs with Jazz Pharmaceuticals plc, which paid $75 million up front
"We are pleased to note that the validity of the Prevenar 13 patent has now been recognized by the Indian Patent Office. Prevenar 13 provides the broadest serotype coverage of any pneumococcal conjugate vaccine available in the world today. Supported by extensive clinical research and real-world experience, each dose of PCV-13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two and a half years to produce."
Saritha Hajare, spokeswoman at Pfizer Inc.
"[The approval is] an important milestone in a long journey we've been on to transform clinical medicine by using modern advances in genomics. The science has reached a point of superiority, where enough of the components of these endeavors are worked out that we can deliver effective therapy to patients."
FDA Commissioner Scott Gottlieb on the approval of Novartis AG's CAR T immunotherapy, Kymriah (tisagenlecleucel, previously CTL-019), to treat children and young adults with B-cell acute lymphoblastic leukemia, which becomes the first gene therapy approval in the U.S.