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HTMLNYC Extends Tax Credit Available to Biotech Companies
Daniel I. DeWolf, Sohail Itani; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 6, 2016, previously published on May 4, 2016
In late 2015, New York City Mayor Bill de Blasio signed into law a three-year extension of NYC’s biotechnology tax credit. The credit, which was set to expire on January 1, 2016, is now available through December 31, 2018. Generally, the biotech tax credit allows emerging biotech companies to...

 

HTMLUSPTO Issues Subject Matter Eligibility Update with Examples for Life Sciences
Fang Xie; Greenberg Traurig, LLP;
Legal Alert/Article
May 26, 2016, previously published on May 5, 2016
Following the recent Supreme Court decisions in Alice Corp., Myriad, and Mayo which invalidated an array of claims under 35 U.S.C. § 101, patent subject matter eligibility has become a closely watched and debated issue. In its most recent attempt to decipher these decisions and apply them in...

 

HTMLDefective INR Device Used in Xarelto Clinical Trials
Law Offices of Peter G. Angelos A Professional Corporation;
Legal Alert/Article
April 18, 2016, previously published on February 15, 2016
In February 2016, BMJ, a medical journal based in the United Kingdom, published a report detailing the use of a faulty device in the Xarelto clinical trials. The Alere international normalized ratio (INR) monitoring device was used to measure blood clotting in patients taking warfarin during the...

 

HTMLUpdating The Biotechnology Mission For The Bioeconomy
Martha E. Marrapese; Keller and Heckman LLP;
Legal Alert/Article
April 14, 2016, previously published on March 15, 2016
What is the bioeconomy? The February 2016 Federal Activities Report on the Bioeconomy describes it as a loose-knit, diverse group of commercial activities with their common frame of reference being the deployment of renewable resources — plants, trees and vegetation — to make useful...

 

HTMLNew Amgen Complaint Seeks Declaration Regarding Participation in the BPCIA's "Patent Dance"
Matthew J. Hertko, Timothy J. Heverin, Gasper J. LaRosa, John A. Marlott; Jones Day;
Legal Alert/Article
March 31, 2016, previously published on March 2016
In the most recent lawsuit involving the Biologics Price Competition and Innovation Act ("BPCIA"), Amgen filed a complaint on March 4, 2016, seeking a declaration that Sandoz has failed to participate in the BPCIA's information-exchange provisions and an order compelling Sandoz to do so....

 

HTMLPacira Secures Expanded Marketing for Painkiller Medication as FDA Agrees to Settle Lawsuit, Revoke Warning Letter
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
January 8, 2016, previously published on December 2015
The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses, as the Food and Drug Administration agreed to allow Pacira expanded marketing for its painkiller drug. The FDA settled a suit in which Pacira alleged the agency had overstepped its bounds by...

 

HTMLDOJ Recoveries Reach $3.5 Billion in FY2015 as Qui Tam Lawsuits Continue to Grow
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
January 8, 2016, previously published on December 2015
For the fourth year in a row, the Department of Justice achieved more than $3.5 billion in settlements and judgments related to fraud and false claims, bringing the total secured from the False Claims Act to $26.4 billion since 2009. The pharmaceutical industry continues to contribute to DOJ...

 

HTMLCDER Director Woodcock Says Agency Will Focus on Filling Vacancies, Negotiating User Fees in 2016
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
January 8, 2016, previously published on December 2015
With a $1.2 billion budget in 2016, the Center for Drug Evaluation and Research will focus on filling hundreds of vacancies, renegotiating user fees and progressing on labeling initiatives.

 

HTMLFDA Publishes Three Major FSMA Final Rules
Edgar J. Asebey, Jonathan Berman, Colleen Heisey; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
On November 13, 2015, the U.S. Food and Drug Administration ("FDA") published the three major rules affecting the food industry that it will adopt in 2015. These include final rules on Foreign Supplier Verification Programs ("FSVP"), Accredited Third-Party Certification, and...

 

HTMLCMS Final Rule Includes Revisions to Stark Law
Jessica Bechtel; Taft Stettinius & Hollister LLP;
Legal Alert/Article
November 27, 2015, previously published on November 12, 2015
On Oct. 30, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a final Medicare physician fee schedule rule that adds two new exceptions and clarifies certain terminology and requirements of the federal physician self-referral law (the “Stark Law”). This final rule with...

 


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