Posts Tagged: drug development
Assessing How Much an Alzheimer’s Drug is Worth
On June 7, 2021, the U.S. Food and Drug Administration (FDA) gave the green light to Aducanumab, a drug developed by Biogen to treat early stage Alzheimer’s, …
Unleashing American Innovation, Oil States and Eroom’s Law
NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private …
A Fleeting Glimpse of Reason in the Drug Development Debate
Despite the difficulties, the private sector is far and away the best bet for developing the desperately needed medicines of the future. Government is a critical partner …
Frances Ligler’s Portable Optical Biosensors Improve Environmental Detection of Toxins, Pollutants
Dr. Frances Ligler is a pioneer in biosensor activity and a member of the 2017 class of inductees into the National Inventors Hall of Fame. This New Years’ …
Embrace IP That Works: Importance of Supplementary Protection Certificates (SPCs) in the European Union
The European Union suffers from an investment deficit relative to other industrialized nations. A recent report by the European Commission emphasizes this impact, “the EU needs to …
Avoiding drug development clinical trials from being an invalidating public use
The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the …
Superbugs Require New Weapons: Strong, Effective Intellectual Property Rights May Be Our Best, Last Hope
The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the …
The FDA process, patents and market exclusivity
A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and "exclusivity" separately. "Exclusivity" refers to exclusive marketing rights granted by the …
Patent issued on vaccine for one of the most common causes of bronchiolitis and pneumonia
Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. …
The National Cancer Institute Didn’t Deserve This Treatment From the New York Times
While those in the military are often thanked for their service, let's also thank researchers like Dr. Rosenberg and his colleagues who spend their lives trying to …
Passage of the 21st Century Cures Act and its Potential Implications on Biodefense
With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.…
Advice for the Trump Administration and New Congress: Protect Bayh-Dole and Restore the Patent System
Bayh-Dole is running on autopilot without Executive branch oversight and U.S. patents are no longer the world's gold standard. Without a course correction, we could be …
Winning the Drug Development Debate
We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration …
Property Rights Key to Bayh-Dole Act’s Success
The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more …
Public Health and Bioscientific War on Superbugs is Hobbled by IP Uncertainties
How will our patent system treat this wonderful new discovery? How long will it take before its curative benefits can be deployed ? We can only hope that …
