By Kurt R. Karst – The Order handed down last week by the U.S. Court of Appeals for the Federal Circuit denying Amgen Inc.’s (“Amgen’s”) Emergency Motion For An Injunction Pending En Banc Consideration and Review and Sandoz Inc.’s (“Sandoz’s”) September 3, 2015 launch of the …
By Kurt R. Karst – Finger through the “Discontinued Drug Product List” section of the Orange Book and youl’ll quickly realize that there are a lot of drug products no longer marketed. The “Discontinued Drug Product List” spans 337 pages in the current annual edition of …
By David C. Gibbons – An August 28, 2015 letter to Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, from the attorneys representing Amarin, Inc. (“Amarin”) indicated that the parties on both sides of Amarin Pharma, Inc. v. FDA, No. 15-3588 …
By Alexander J. Varond – Hardly a week goes by without news of FDA’s priority review voucher (“PRV”) programs. The last several weeks are no exception. In this blog post, we focus on five key updates related to FDA’s tropical disease and rare pediatric disease (“Pediatric”) …
By James C. Shehan – On August 27, 2015, FDA published its much–anticipated views on the non-proprietary naming of biological products. Set forth in a proposed rule, a draft guidance, and a blog post, FDA proposes that a four letter suffix “devoid of meaning” be part …
By David C. Gibbons – As we reported in a previous post, the House Committee on Energy and Commerce requested that FDA answer a number of questions regarding how FDA Centers issue and publicly disclose Untitled Letters (“ULs”). As readers may recall, the letter to FDA …
By Alexander J. Varond & James E. Valentine* – FDA recently released a draft guidance, titled “Rare Diseases: Common Issues in Drug Development.” The fourteen-page document amounts to more of a primer than a focused discussion of technical issues. It serves as a useful reminder of the …
By James E. Valentine* – On August 17, 2015, FDA announced the availability of an update to its 11 year old guidance on botanical drug development. Botanicals are plant materials, algae, macroscopic fungi, and combinations of those things that can be regulated as a food (including a …
By James C. Shehan – We’ve all been told that consistency is a virtue and some recent developments have AbbVie’s consistency on display while that company questions FDA’s biosimilar labeling morality, or at least decision-making. In a citizen petition supplement recently submitted to FDA, AbbVie renewed …
By Kurt R. Karst – Back in September 2013, when FDA’s Office of Generic Drugs (“OGD”) was gearing up for significant implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) (and the associated Performance Goals and Procedures), the Office issued a Manual of Policies …
By Kurt R. Karst – It seems that hardly a week passes (and sometimes, hardly a day or two) without news of a new merger or acquisition in the pharmaceutical or biotechnology industries. Indeed, 2015 may be a record-breaking year for such deals (see here, here, …
By James C. Shehan – In the latest Biologics Price Competition and Innovation Act of 2009 ("BPCIA") patent dance development, Amgen filed a lawsuit alleging that Apotex’s biosimilar of Neulasta (pegfilgrastim) infringes two Amgen patents, one about to expire composition of matter patent and one process …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maryland unsealed a 73-page Opinion handed down on July 29, 2015, along with an Order, in a challenge brought by Mallinckrodt Inc. (“Mallinckrodt”) last November after FDA downgraded from “AB” …
By Kurt R. Karst – There are few things this blogger relishes more in his practice than getting his hands on FDA exclusivity decisions. (It’s like being given and then unwrapping a holiday gift.) We don’t mean the “decisions” that most people see in ANDA approval letters …
By David C. Gibbons – On Friday, August 7, Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, handed down one of the most significant rulings concerning First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug. Judge …
