The mystery started last June. That's when Novartis AG disclosed top-line results from the tests that pitted its VEGF-A ligand inhibitor, brolucizumab (RTH-258), in neovascular age-related macular degeneration (AMD) against Regeneron Pharmaceuticals Inc.'s flagship product, Eylea (aflibercept).
Having taken in the data from the phase IIa Action study with Tysabri (natalizumab) by Biogen Inc., investors weren't too surprised by results from the phase IIb, dose-ranging Action 2 experiment in acute ischemic stroke (AIS) that turned up no improvement compared to placebo.
Bristol-Myers Squibb Co.'s (BMS) chief scientific officer (CSO), Thomas Lynch, said the firm has not seen any overall survival (OS) data from the phase III Checkmate-227 study, and called the progression-free survival (PFS) data "very fresh to us. We look forward to reporting those at an important medical meeting," and will publish the results in a scientific journal "as soon as we possibly can," he said.
Word for Pharming Group NV in mid-January of an action date regarding the supplemental BLA for the C1-esterase inhibitor Ruconest, followed by news four days later that Biocryst Pharmaceuticals Inc. and Idera Pharmaceuticals Inc. will merge, added yet another shift in the hereditary angioedema (HAE) space.
Like many others – except, as usual, for significantly more money – Moderna Therapeutics Inc. took advantage of a generous market to raise $500 million from new U.S. and international institutional investors, as well as institutional supporters already on board.
The Medicines Co.'s brisk enrollment of the confirmatory, phase III, 1,500-patient Orion-11 trial with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor inclisiran not only bodes well for the firm but may say something about the already approved therapies in the class as well.
Bridgebio Pharma Inc.'s asset hunter Michael Henderson told BioWorld his firm "came a bit late in the game" when attempting to grab a phase II cancer asset that Novartis AG no longer wanted, but officials "burned some nights and weekends" to win.
Approval last week by the FDA of Novartis AG's radioactive drug, Lutathera (lutetium [177Lu] oxodotreotide), provides "a signal that there's a real opportunity for this kind of therapy, and it goes beyond neuroendocrine and prostate cancers," Endocyte Inc. CEO Mike Sherman told BioWorld.
Friday's approval of the resubmitted NDA for Lutathera (lutetium [177Lu] oxodotreotide) stands as proof that issues raised by a complete response letter (CRL) "were really on technical problems," Stefan Buono, former CEO of Advanced Accelerator Applications SA (AAA), told BioWorld.
The FDA cleared Apexian Pharmaceuticals Inc.'s IND for oncology candidate APX-3330 in three days, CEO Steve Carchedi told BioWorld, "which is probably a world record. It was, at that time, the most widely used unapproved drug," with safety data in no fewer than 422 patients already available.
