The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning.
In a deal that could reach nearly $2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. has licensed a small molecule for treating cardiovascular disease to Merck & Co. Inc., dropping the China-based company into a space with lots of competitors in varying stages of development.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
Novartis AG is paying nearly $1 billion up front to buy privately held Anthos Therapeutics Inc. in a deal that eventually could top out around $3.1 billion. Novartis, coming back to where it started as it and Blackstone Life Sciences founded Anthos in 2019, is entering a crowded space.
Amid a strengthening offensive against direct-to-consumer drug ads, two senators flagged a Super Bowl ad promoting compounded drugs as part of the company’s attack on the U.S. weight-loss industry that it said was built to keep Americans “sick and stuck.”
BioWorld’s three-part analysis of M&As sought to discover successful transactions and to understand the trend of multibillion-dollar deals that have become commonplace in the last decade. Instead, more than 80% of the acquisitions explored simply indicate that buyers are paying too much, suggesting that transactions meant to restore pipelines and revenues with innovative and marketed products are sometimes akin to high-stakes gambling. In part three, the final part of this series, we examine four more disappointments in which the return on investment (ROI) remains well behind the price paid in acquiring the company.
Novartis AG has synthesized new sodium channel protein type 5 subunit alpha (SCN5A; Nav1.5) blockers reported to be useful for the treatment of heart failure, long QT syndrome, hypertrophic cardiomyopathy, angina pectoris, myotonia, ventricular tachycardia, atrial and ventricular fibrillation, among others.
