Legal
Sandoz’ biosimilar to Enbrel was approved in 2016 by the FDA but has remained off the market due to the patent protection surrounding Amgen’s blockbuster rheumatoid arthritis treatment.
Pratteln, Switzerland, August 2, 2019 – Santhera Pharmaceuticals announces the closing of the licensing transaction with Chiesi Farmaceutici, an international research-focused healthcare group.
Although the lawsuits over who owns the rights to gene editing technique CRISPR seemed to be mostly settled in September 2018, a recent dispute between the University of California and the Cambridge, Massachusetts-based Broad Institute suggested the battles aren’t done yet.
Teva Pharmaceuticals, Endo Pharmaceuticals and Taikoku Pharma entered into settlement agreements with the State of California for a total of almost $70 million. The settlements were over non-competitive, inter-company deals that prevented cheaper drugs from entering the market.
Specifically, the civil subpoenas were issued to determine if the company had violated antitrust laws with its rheumatoid arthritis drug Remicade.
Patents and intellectual property protections are a big deal in the biopharma industry. One reason is simply the timeline of drugs and therapeutics. Biopharma has several unique challenges, but one of them is the patent cliff.
A three-judge panel ruled against Shkreli’s appeals team, claiming that the trial judge’s directions were clear and within the law.
A federal judge ordered that information on sales of opioids up to the year 2013 could be released.
In November 2018, Chinese researcher He Jiankui announced he had used CRISPR gene editing to modify the CCR5 genes in the embryos of seven Chinese couples. This was met by widespread condemnation, investigations and a call for a global moratorium against that type of research.
The Sackler family has earned billions from the sale of OxyContin and the backlash against the family has increased in-fighting, according to reports.
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