Posts Tagged: fda


Hybrigenics gets Orphan Drug designation for the treatment of Acute Myeloid Leukemia

Hybrigenics (ALHYG), a French bio-pharmaceutical company with a focus on research and development of new treatments against proliferative diseases, has announced that the Food and Drug Administration (…
21 days ago 0

Federal Circuit Review – Issue 61 – July 31, 2015

Amgen filed a biologics license application (“BLA”) and obtained FDA approval for its filgrastim product, Neupogen. Sandoz subsequently filed an abbreviated BLA (“aBLA”) under 42 U.S.C. § 262(…
1 month ago 1

When Lives Depend on Tech Transfer

Nothing clarified the stakes in orphan drug development like hearing Ron Bartek describe how after 16 years a promising treatment for his son’s disease finally emerged with …
10 months ago 0

SCOTUS: FDA Regulations No Bar to Lanham Act Claims

The Supreme Court reversed a decision from the Ninth Circuit that held that within the realm of labeling for food and beverages, a Lanham Act claim asserting …
1 year ago 0

Pharma Update: News for April 2014

What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. Supreme Court Denies Teva's Request …
1 year ago 0

Mylan’s Prevails in Perforomist® Patent Dispute

Mylan Inc. (NASDAQ: MYL) recently prevailed in the United States District Court for the Northern District of West Virginia in a patent dispute involving Perforomist® (formoterol fumarate) …
1 year ago 0

Seven IP Cases Slated on Supreme Court Oral Argument Calendar

The Court will hear oral argument as follows: on February 26, in two cases on granting (Octane Fitness) and reviewing (Highmark) attorneys’ fee awards; on March 31, in a …
2 years ago 0

Biotech and Pharma Update: January 2014

Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** …
2 years ago 1

Pharma & Biotech Update: News for October 2013

Mouse Model of Parkinson's Disease Shows Improved Brain Function --- DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™ --- Actavis Files ANDA for Generic Suboxone® Sublingual Film …
2 years ago 2

Patent News and Notes

1. Reed Tech takes over USPTO Contract from Google. 2. Pharma Patent Settlements Saved $25.5 Billion for US Health System. 3. Coffee Analysis Smart Phone App for that Perfect Brew. 4.FDA …
2 years ago 0

Pharma Update July 2013: FDA, Preemption & SCOTUS

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current …
2 years ago 0

FDA Approves New Labeling for Merck Blockbuster HIV Drug ISENTRESS

This newly approved, updated prescribing information for ISENTERSS now includes 240-week results from the STARTMRK study, the double-blind Phase III study that evaluated integrase inhibitor in previously …
2 years ago 0