The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson, the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal strategy against biosimilar competitors, including...more
11/18/2024
/ Antitrust Provisions ,
Biosimilars ,
Health Care Providers ,
Insurance Industry ,
Inter Partes Review (IPR) Proceeding ,
Johnson & Johnson ,
Life Sciences ,
Misrepresentation ,
Motion to Dismiss ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Settlement ,
USPTO
On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more
On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in...more
On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act. The Act allows eligible...more
On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more
On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™ (dronabinol) oral solution, a Schedule II (CII) controlled substance. Syndros™ was initially approved by the FDA on July 5, 2016...more
“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more
Every year, the FDA’s Center for Drug Evaluation and Research (CDER) approves new medications. Some medications are variations of existing products, such as generic formulations or new dosage forms of previously-approved...more