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Confidential Information Prescription Drugs

Husch Blackwell LLP

California Enacts First-in-Nation Pharmacy Medication Error Reporting Law

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On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that...more

Goodwin

JHL Biotech Co-Founders Convicted in Genentech Trade Secret Theft

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Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and...more

Goodwin

Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court...

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On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent...more

K&L Gates LLP

K&L Gates Triage: Modernizing Confidentiality Rules for Substance Use Disorder Records (Again): 2019 Proposed Changes to 42 CFR...

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This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1...

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This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more

Bradley Arant Boult Cummings LLP

HHS Proposes Revisions to Part 2 Regulations Governing Confidentiality of Substance Use Disorder Records - Healthcare Alert

On August 26, 2019, the Substance Abuse and Mental Health Services Administration, part of the U.S. Department of Health and Human Services (HHS), published its much-anticipated notice of proposed rulemaking to revise 42...more

Smart & Biggar

Countdown to July 1, 2020: Getting Ready for the New Patented Medicines Pricing Regime

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On August 21st, the long-awaited amendments to the Patented Medicines Regulations were published in Part II of the Canada Gazette. We have prepared an unofficial consolidated version of the Regulations incorporating the...more

Smart & Biggar

First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data

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In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

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Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

Dorsey & Whitney LLP

Cooperation, the SEC and FOIA

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A critical part of cooperating with an SEC or DOJ investigation for FCPA or other possible violations is the production of documents. In order for the company to assess what happened it must conduct an internal investigation...more

McDonnell Boehnen Hulbert & Berghoff LLP

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)

Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as the...more

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