Posts Tagged ‘FDA’

Why Did the Chicken Cross the Road? To Get New Genes!

Thursday, December 10th, 2015

chickenJay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes:

On December 8, 2015, FDA issued a complex set of approvals for a unique product, Kanuma (sebelipase alfa).  Kanuma is indicated for the treatment of a rare disease known as lysosomal acid lipase (LAL) deficiency.  The list of distinguishing descriptors for the Kanuma application is lengthy:  Kanuma received orphan product designation, received breakthrough therapy designation, was given priority review, and was granted a rare pediatric disease priority review voucher.

There is a lot to discuss about the Kanuma approval, and we will try to keep it high-level in the interest of our readers’ time. . .

You can read the entire post here.

FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents.

You can find the article here.

Patents4Life is Six Years Old this Month. Happy Birthday to Us!

Tuesday, March 3rd, 2015

OLYMPUS DIGITAL CAMERASix years ago, In re Kubin caused a flurry of concern among biotech practitioners, and a short article on this decision was the first post on Patents4Life. That was a pretty big “story” at the time but we all had no idea what was coming our way. It is difficult to think of an area of patent law that hasn’t been through a sea change since 2009, or at least has not encountered some very high seas.

There are not enough hours in today to do even a cursory review of the “State of Patent Law” since Patents4Life was started. Of course, one of the hottest topics right now is the scope of s. 101, and its breadth will surely be adjusted as the precedent piles up. And just consider, all of this debate is completely outside of the changes wrought in 35 USC by the AIA, the rise of generic biologicals that was set off by the ACA (“Obamacase”) and the Therasense, Teva v. Sandoz and Nautilus decisions.

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FDA Publishes “Purple Book” for Biologicals/Biosimilars

Thursday, September 11th, 2014

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked here is the publication from BIO’s new Intellectual Property Newsletter that links to the FDA press release from the FDA Blog.

CDER List of Licensed Biological Products

CBER List of Licensed Biological Products