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Harris Bricken | USA | 18 Oct 2022
Court of International Trade OKs “Drug Paraphernalia” Import to Washington
The U.S. Court of International Trade (“CIT”) issued a recent opinion that indicates the import or export of “drug paraphernalia” to or from states…
Lexology PRO | European Union, United Kingdom | 5 Aug 2021
CMA reaccuses Pfizer and Flynn of excessive pricing
The UK’s Competition and Markets Authority has accused Pfizer and Flynn Pharma of charging unfairly high prices for an anti-epilepsy medication, 17 months after an appellate court ordered the agency to redo parts of its initial probe into the drugmakers.
Lexology PRO | United Kingdom | 29 Jul 2021
CMA doles out £100 million in fines for excessive pricing of thyroid drug
The UK’s Competition and Markets Authority has hit Advanz Pharma and its two former owners with more than £100 million in fines for overcharging the country’s national health service for thyroid medication liothyronine over an eight-year period.
Lexology PRO | European Union, Italy, Netherlands, etc. | 19 Jul 2021
Dutch enforcer issues first excessive pricing fine
The Dutch competition authority has fined Leadiant Biosciences €17.9 million for charging excessively high prices for a drug used to treat a rare genetic metabolic disorder, marking the first time it has ever imposed a penalty for such an infringement.
Dykema Gossett PLLC | USA | 2 Apr 2019
FDA Statement on Cannabis-Containing and Cannabis-Derived Products
On April 2, 2019 the FDA further described its upcoming effort to regulate or at least discuss the regulation of cannabis-containing and…
Morgan, Lewis & Bockius LLP | USA | 8 Mar 2019
FDA Sings the Orange Book Blues to Announce a Potential New Patent Listing Approach
The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List…
Jones Day | USA | 31 Jan 2019
Appellate Standing Not Precluded By Inability To Maintain Hatch-Waxman Suit
Mylan Pharmaceuticals, Inc. petitioned for inter partes review (IPR) of U.S. Patent No. 6,858,650 (the “‘650 Patent”), which is owned by UCB Pharma…
Hogan Lovells | USA | 30 Oct 2018
CMS considers linking Medicare drug payment rates to international prices
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential…
Smart & Biggar | Canada | 29 Oct 2018
Certificate of supplementary protection regime: first anniversary update
The first anniversary of the certificate of supplementary protection (CSP) regime was 21 September 2018. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in researching and obtaining regulatory approval in Canada. This article looks back on the previous year, recaps how the regime works and provides an update on......
Seyfarth Shaw LLP | USA | 24 Oct 2018
Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs…
