Compliance Perspectives: The FBI on Why and How to Work with the Office of the Private Sector
The Compliance Challenge: Managing Legal & Regulatory Risk
Webinar: How to Get Your Lawyers Sharing Successfully on LinkedIn - with @AdrianDayton
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
FCPA Compliance and Ethics Report-Episode 51-Interview with Tim Haidar
ACADEMI's Suzanne Rich Folsom and PwC's Glenn Ware on Moral Hazard
What Companies Should Do to Prepare for Implementation of Cybersecurity Executive Order
Where Does the Cybersecurity Executive Order Hit and Miss the Mark?
As industry and markets have progressed, the technology they create has seen a commensurate increase in complexity. In practice, this results in the hyper-specialization of businesses so that they may continue to innovate at...more
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price...more
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more
Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more
The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more