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15 Apr 2010, 7:04 am by FDABlog HPM
District Court for the Eastern District of Michigan (Southern Division) ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. [read post]
12 Apr 2010, 12:14 pm by Theo Richards
The Slidell Heritage Foundation, Inc., recently announced its 2010 charitable grant recipients. [read post]
7 Apr 2010, 4:30 am
– FDA’s approval letter for Orchid’s ANDA for generic Clarinex sets new 180-day exclusivity forfeiture (FDA Law Blog) Cozaar (Losartan) / Hyzaar (Hydrochlorothiazide, Losartan) – US: Rarely used exception to the first permitted commercial marketing/use PTE criterion (FDA Law Blog) Cozaar (Losartan) / Hyzaar (Hydrochlorothiazide, Losartan) – US: Generic Cozaar/Hyzaar 180-day exclusivity – Teva wins, FDA too (despite itself) in the Columbia… [read post]
1 Apr 2010, 3:12 pm by Lebowitz & Mzhen
The F.D.A. sent letters last week to two major nitroglycerin drug makers, Konec Inc., and Glenmark Generics Inc., warning them that they must stop selling the unapproved drugs. [read post]
1 Apr 2010, 3:04 am
MDCO launches another lawsuit against the PTO over Angiomax PTE (FDA Law Blog) Arzerra (Ofatumumab) – US: Biogen files patent infringement suit in S D California against Glaxosmithkline based on manufacture and sale of Arzerra (Patent Docs) Arzerra (Ofatumumab) – US: Genetech files counterclaims in declaratory judgment suit brought by GlaxoSmithKline (Patent Docs) Astelin (Azelastine) – US: District Court New Jersey: Patent infringement complaint following Para IV challenge: Meda… [read post]
25 Mar 2010, 1:13 pm
Int'l Trade Comm'n, 180 F.3d 1354, 1365 (Fed. [read post]
22 Mar 2010, 4:13 am by Sean Wajert
Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1320 (9th Cir.), cert denied, 516 U.S. 869 (1995); see also In re W.R. [read post]
18 Mar 2010, 6:38 am by admin
Inc., the complainant changed counsel three times and failed to respond to discovery requests. [read post]