Posts Tagged: Food and Drug Administration


21st Century Cures Act passed overwhelmingly by House, major health reform bill moves to Senate

The 21st Century Cures Act has broad bipartisan support having been passed in the U.S. House by an overwhelming 344-77 roll call vote. It also has …
By Steve Brachmann
3 years ago 18

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug …
By Gene Quinn & Steve Brachmann
3 years ago 0

Is Nome, Alaska ready for Paragraph 4 ANDA litigation? How about San Juan, Puerto Rico?

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a …
By Jennifer Mauri
3 years ago 2

Government is to blame for the skyrocketing price of EpiPens, not patents

The problem is that the government is standing in the way of these competitive autoinjectors getting into the hands of the patients who need them. For example, …
By Brett Trout
3 years ago 23

Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications on generic Pennsaid

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants …
By Steve Brachmann
3 years ago 0

Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would …

FDA approval of Teflaro puts Allergan’s portfolio of anti-infectives into focus

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one …
By Steve Brachmann
3 years ago 0

IP Protection Critical for BioPharma Given Number, Cost and Complexity of Clinical Trials

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated …

A look at treatments for hepatitis C, America’s top infectious disease killer

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss …
By Steve Brachmann
4 years ago 1

The Evolution of Food Safety: HOF Inventors John Silliker and Welton Taylor tamed Salmonella

The 2016 inductee class for the National Inventors Hall of Fame includes two microbiologists whose contributions to the field of food safety have helped to keep many foodborne …
By Steve Brachmann
4 years ago 0

Free Drugs: Bernie Sanders and the end of drug patent exclusivity

The Medical Innovation Prize Act of 2007, submitted by Senator Bernie Sanders (D-VT), would have effectively done away with patent rights for pharmaceutical drugs approved by the Food …
By Gene Quinn
4 years ago 41

Illicit pharmaceutical drug sales find a home on Twitter

Twitter’s popularity has not only benefited the legitimate side of the pharmaceutical industry. A study released in December, supported by both the Global Health Policy Institute …
By Steve Brachmann
4 years ago 0

Phase 3 trial starts for treatment for peanut allergy

It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United …
By Gene Quinn
4 years ago 5

The future of agricultural pest control is biopesticides, IoT insect monitoring systems

The Internet of Things has been lauded as a potential boon for crop production, including pest control. Automated IoT pest control systems have been developed by Spensa …
By Steve Brachmann
4 years ago 0

Pharmaceutical greed makes Martin Shkreli public enemy #1

On August 10th, the rights to sell Daraprim were bought from Impax Laboratories Inc. (NASDAQ:IPXL) of Hayward, CA, by Turing Pharmaceuticals, a privately held company with …
By Steve Brachmann
4 years ago 11