Everything Compliance-Episode 63, the Novartis edition
Episode 150 -- Novartis Settles False Claims Act and Anti-Kickback Cases for $729 Million
Daily Compliance News: July 2, 2020-the Novartis Pays More edition
Compliance into the Weeds: Episode 178-the Novartis FCPA Enforcement Action
Episode 148 -- A Review of the Novartis and Alcon FCPA Enforcement Action
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more
Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline. Pegfligrastim - As we previously reported last July, the FDA last year...more
Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front...more
Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved...more
According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70%...more
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more
On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will...more
Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more
A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more