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…in the drug/biological product approval process SEE the importance of cGMPs to the post-approval regulatory process NAVIGATE the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies…
…the “First Effective” approach post-MMA effectively writes out of the statutory definition of “First Applicant” the reference to the “first day” in the “when” prong of that definition in cases…
…to wait until final judgment to appeal rulings). Amgen argued that waiting until final judgment renders the decision “effectively unreviewable,” but the Federal Circuit could not identify a clear-cut statutory…
…any other applicant (which other applicant has received tentative approval)” or patent delisting. Citing the court’s three-factor stay standard articulated in In re Brimonidine Patent Litig., No. 07-md-1866 (D. Del….
…a 30-month stay on the approval of NDA 208090. See Purdue Pharma LP et al. v. Colleaium Pharmaceutical Inc., Case 1:15-cv-00260 (D. Del. Mar. 24, 2015); Purdue Pharma L.P. et…
…its initial complaint against Hospira alleging patent infringement and failure to comply with various provisions of the BPCIA with respect to a biosimilar version of Epogen. Relevant to this revised…
…it is unconstitutional under the dormant commerce clause (having the practical effect of regulating commerce occurring wholly outside that State’s borders). PhRMA also requests an injunction barring Defendants from implementing…
…success. Starting August 2020, several drug manufacturers announced that they would offer 340B prices only to covered entities that have an in-house pharmacy or contract with a single contract pharmacy,…
…deliberate anticompetitive tactics commenced as early as 2005, Defendants have harmed [Mylan] and the public by preventing and/or delaying generic competition to Doryx – a delayed-release doxycycline hyclate product prescribed…
…olmesartan medoxomil drug products until the expiration the ‘599 patent and “all extensions” thereof. The August 2009 Final Judgment doesn’t identify the precise date when Mylan would be free to…
…to justify injunctive relief. The Hornbeam court lamented past judicial rulings that allowed section 13(b) to expand beyond its statutory language, noting that section 13(b) [I]s not, on its face,…
…. . contradicts the plain text of the statute and therefore must be set aside.” Id.; see also 42 U.S.C. § 1320f-1(e)(1)(A). Second, AstraZeneca alleged that CMS’s requirement that a…
Last February we reported on FTC v. Shire ViroPharma, in which the Federal Trade Commission (FTC) took the relatively unusual (although not unprecedented) step of suing a brand drug company…
…Pharmaceuticals International’s (“Valeant’s”) EFUDEX (fluorouracil) Topical Cream, 5%, did not violate the Administrative Procedures Act (“APA”). EFUDEX (also known as 5-FU) is a locally-acting antineoplastic drug product FDA first approved…
…below the threshold at which a warning statement is required; and (3) almost all the methylmercury in canned tuna is “naturally occurring” and therefore no warning statement is required. The…