Austin, Texas, biotech Aeglea Biotherapeutics raised $44 million in Series B cash to bankroll its enzyme-replacement therapy for a rare metabolic disorder, with Eli Lilly and Novartis leading the round.
Novartis made history this month with the first FDA approval of a biosimilar, and now a judge's ruling has cleared the way for its launch. The drug, Zarxio, is a copy of Amgen's blockbuster Neupogen, which is designed to boost white blood cell counts.
Novartis CEO Joe Jimenez was a bit dismissive about the immediate impact of biosimilars when his company became the first to get one approved in the U.S. But Amgen didn't see the biosimilar of its blockbuster Neupogen in quite the same light and tried to stop its release. Unfortunately for the company, a federal judge denied Amgen's request for a temporary injunction.
Several years ago, Novartis agreed to pay $175 million to settle a high-profile gender discrimination lawsuit focused on its U.S. sales operations. Now, the Swiss drugmaker faces a new discrimination fight at its Texas-based Alcon unit.
England's Cancer Drugs Fund is backtracking in its decision to remove certain treatments from its list of covered drugs, agreeing to keep Novartis' cancer med Afinitor for two of the three indications for which it was supposed to be removed.
Novartis and Roche can wash their hands of some kickback accusations. A federal judge tossed a long-standing whistleblower suit Tuesday, nixing allegations that the two drugmakers used kickbacks and off-label promotions to pump up sales of their asthma drug Xolair.
A Japanese physician testified in a case involving Novartis Pharma K.K. and its Diovan (valsartan) drug for high blood pressure that he falsified a report while participating in clinical trials for marketing approval, sources said.
Novartis has agreed to pay the largest-ever settlement over allegations of inaccurate or outdated drug-price reporting to the federal government, HHS officials say. That's not saying much, however: This record-breaking settlement amounts to $12.64 million.
A Japan physician testified in a case involving Novartis Pharma K.K. and its Diovan (valsartan) drug for high blood pressure that he falsified a report while participating in clinical trials marketing approval, sources said.
England's cost-effectiveness watchdogs have changed their mind on Xolair. The National Institute for Health and Care Excellence decided to back the Novartis asthma drug as a treatment for chronic hives, after sending the drugmaker back for more data last year.