Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway.
News of GSK plc’s decision to decline its option for MAT2A inhibitor IDE-397, the lead compound from a 2020 collaboration with Ideaya Biosciences Inc. sent the latter’s shares (NASDAQ:IDYA) slipping 35% to close Aug. 15 at $10.20. For Ideaya, however, which maintained that it has sufficient capital to see the program through phase II on its own, the move works out just fine.
Mersana Therapeutics Inc. is getting $100 million up front in an option deal with GSK plc for preclinical-stage antibody-drug conjugate (ADC) XMT-2056, which could bring up to $1.36 billion more in an option exercise payment, development, regulatory and commercial milestones. It’s the second potential $1 billion-plus ADC deal for Cambridge, Mass.-based Mersana in 2022 and the first for its Immunosynthen platform, which uses a STING agonist payload specifically designed for ADCs.
GSK plc, formerly Glaxosmithkline plc, has begun a significant new chapter in its history with the spin-off this week of its consumer business known as Haleon plc. While the high-profile new listing of Weybridge, Surrey-based Haleon (LON:HLN), the largest in Europe in a decade, grabbed the headlines, investors are keeping a sharp eye on GSK now that it is free to focus on developing and marketing novel drugs.
As a last-ditch effort to preserve skinny labeling for generics, Teva Pharmaceuticals USA Inc. is asking the U.S. Supreme Court to review a Federal Circuit split opinion in Glaxosmithkline plc v. Teva Pharmaceuticals that upset the status quo of the generic marketplace.
Sanofi SA and GSK plc were beat to market during the first wave of COVID-19 by vaccines from upstarts such as Biontech SE and Moderna Inc. – but the French and U.K. vaccine specialists are gaining traction in the race to develop booster shots against newer variants.
