A science fiction author in the mid-1970s envisioned a future in which a deteriorating environment and limited resources meant we were all on an algae-based diet. ...more
As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more
12/27/2016
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen
It took over a decade to sequence the human genome the first time, at a cost between half a billion and a billion dollars. Now, however? An entire human genome can be sequenced for one or two thousand dollars, in a matter of...more
Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more
10/17/2016
/ Best Practices ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medical Devices ,
Mobile Apps ,
PHI ,
Pokemon ,
Popular ,
Privacy Concerns ,
Security Standards ,
Smartphones ,
Technology ,
Technology Sector ,
Third-Party Service Provider ,
Wellness Programs
Tuesday, September 22, 2015, 1:00 P.M. CST -- Both the FDA and the FTC have been busy this summer. Just this month, both agencies took their strongest actions to date relating to cybersecurity and the regulation of medical...more
The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more
4/9/2015
/ Best Management Practices ,
Data Mining ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Hospitals ,
Labeling ,
Medical Devices ,
Patients ,
Pharmaceutical Industry ,
Privacy Laws ,
Risk Management ,
Social Media ,
Terms of Use ,
User-Generated Content
For almost 40 years the FDA has regulated in vitro diagnostics (IVDs) as medical devices. An IVD is a reagent, instrument, or system that is intended for the diagnosis of a disease or other condition, including the...more
Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more