Tag Archives: FDA

Financial Daily Dose 8.7.2019 | Top Story: Novartis Hid Altered Drug Test Data From FDA

BY: Michael D. Reif | August 7, 2019

A new report out Tuesday from the Food & Drug Administration reveals that drug maker Novartis “concealed manipulated data” from the agency “while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue.” Still, the FDA is keeping Zolgensma, the drug in question, on the market – NYTimes and … Continue reading

Your Daily Dose of Financial News

BY: Michael D. Reif | November 16, 2018

A no-deal Brexit wouldn’t merely be a disaster for PM May’s government. It would wreak definite havoc on UK-based companies (and those that do big business there). Here’s what they’re sweating at the moment – WSJ Quick update related to the Juul announcement earlier this week restricting some of its advertising and bricks-and-mortar offerings. The … Continue reading

Listing Device Patents in the Orange Book: Can You Do That?

BY: Jake Holdreith | May 8, 2018

One of the most significant obstacles to drug competition is a patent listed in FDA’s “Orange Book.” The mere listing of a patent can delay competition for months, or even years, and drive up expense for competitors. Drug patent owners want to extend the patent protection on their products for as long as they can, … Continue reading

Hatch-Waxman Venue: The New Narrow?

BY: Jeff Hovden | December 8, 2017

The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party can be sued in a forum. A party’s personal ties to a forum can be sufficient under either general or … Continue reading

When Time is Money

BY: Sharon Roberg-Perez | December 27, 2016

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 in their cases against Amgen. The issue? A provision in 2010’s Biologics Price Competition and … Continue reading

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

BY: Kelsey Thorkelson | November 2, 2016

Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the Federal Circuit in Acorda Therapeutics v. Mylan Pharma (Fed. Cir. 2016) allowing generic companies to be sued … Continue reading

Genomics and FDA Regulation: A Work in Progress

BY: Sharon Roberg-Perez | October 26, 2016

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 days. But we are far from the point at which an individual’s … Continue reading

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

BY: Jeff Hovden | October 10, 2016

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic drugs. Until now, the FDA has been issuing requirements based on the statute itself for how brand-name drug companies list their patents, craft … Continue reading

The Tech Industry’s Next Frontier?

BY: Sharon Roberg-Perez | October 5, 2016

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 the way to address this is intervention at a point far earlier in time than when … Continue reading