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Latest From Legal Issues

Impax Defeats FTC Pay-For-Delay Complaint, Helped By Status As Sole Marketer Of Generic Opana ER

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

Generic Drugs Legal Issues

Brexit Could Make UK A 'Second-Tier State' For Innovative New Drugs, Business Committee Warns

A report from the UK House of Commons business committee on its inquiry into the impact of Brexit on the pharma sector has flagged up the multiple challenges facing companies and regulators.
Brexit Approvals

Amgen’s Challenge Over Sensipar Pediatric Exclusivity Moves To US Appeals Court

Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.

Legal Issues Intellectual Property

Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear

First biosimilar of Epogen/Procrit might launch this year, but timing of market entry will depend on many factors, including ongoing patent litigation with Amgen in Delaware federal court.


Biosimilars Approvals

EU Legal Opinion In Truvada Case Could Complicate SPC Grant Process

In one of several cases under way regarding the criteria for awarding supplementary protection certificates, an advocate general of the Court of Justice of the EU has come up with some new legal tests that experts say could make it more difficult to obtain SPCs in certain circumstances.
Intellectual Property Legal Issues

You Work In The Pharmaceutical Industry; Here's Why You Should Care About The Novartis Payments

There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.

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