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Wilson Sonsini Goodrich & Rosati

Biden Administration Inks Bills to Increase Drug Competition

Also Codifies FDA's Longstanding "Active Moiety" Approach for New Chemical Entity Exclusivity - In April 2021, President Biden signed two bipartisan bills that aim to promote drug competition and to reduce prescription...more

Troutman Pepper

Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

Troutman Pepper on

Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more

Smart & Biggar

Rx IP Update - May 2018

Smart & Biggar on

An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

Knobbe Martens

Third Circuit Upholds Dismissal of Doryx ‘Product Hopping’ Suit

Knobbe Martens on

On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more

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