News & Analysis as of

Prescription Drugs

UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

FDA Approves Zelboraf for Treatment of a Rare Cancer

by Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

Department of Transportation Adds Four New Drugs to Testing Panel

by FordHarrison on

On November 13, 2017, the Department of Transportation (DOT) announced that it is amending its drug-testing program to require testing for synthetic opioids. The new DOT regulations now harmonize with the Department of Health...more

Medicaid Forecast: Slower Enrollment Growth and Higher Spending Growth for FY 2017 – 2018: Results from a 50-State Medicaid Budget...

by Baker Ober Health Law on

On October 19, Kaiser Family Foundation and Health Management Associates hosted a joint briefing to release their 17th Annual 50-State Medicaid Budget Survey for state fiscal years (FY) 2017 and 2018. The survey highlights...more

In re Sebela Patent Litigation

by Robins Kaplan LLP on

Case Name: In re Sebela Patent Litigation, 14-6414 (CCC) (MF), 2017 U.S. Dist. Lexis 128258 (D.N.J. Aug. 11, 2017) (Cecchi, J.). Drug Product and Patents-in-Suit: Brisdelle® (paroxetine mesylate); U.S. Patents Nos....more

The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more

Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc.

by Robins Kaplan LLP on

Case Name: Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., 11-2317 (MLC) (DEA), 2017 U.S. Dist. LEXIS 107707 (D.N.J. July 12, 2017) (Cooper, J.). Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen / esomeprazole...more

AGG Food and Drug Newsletter - November 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Opioid Litigation Over Insurance Coverage – Coming to a Jurisdiction Near You

by Nexsen Pruet, PLLC on

A very recent appellate ruling in California provides a roadmap for opioid litigation over insurance coverage that is about to ramp up all over country. In Travelers Prop. Cas. Co. of Am. v. Actavis, Inc. et al, 2017 WL...more

Ferring Pharms. Inc. v. Par Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Ferring Pharms. Inc. v. Par Pharm., Inc., Civ. No. 1:15-cv-173-RGA, 2017 U.S. Dist. LEXIS 106491 (D. Del. July 11, 2017) (Andrews, J.). Drug Product and U.S. Patent: Prepopik® (sodium picosulfate, magnesium...more

De-Bunking the Opioid Litigation Epidemic

by Kelley Drye & Warren LLP on

If you type ‘opioids’ into a search engine, chances are you’ll be greeted with headlines like: “Opioid abuse is in everyone’s backyard”. The Washington Post writes: “Even this puppy wasn’t safe from America’s opioid crisis”;...more

The Opioid Epidemic: Are We Headed Toward a Tipping Point?

by Burr & Forman on

Health care law and policy occupy a prime place in the current news cycle. Much of the attention revolves around the actions or inactions of Congress and the White House, particularly with regard to their impact on the future...more

K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

by K&L Gates LLP on

In this episode, Richard Church and Ryan Severson discuss the recent decision by the Centers for Medicare and Medicaid Services (CMS) to substantially decrease reimbursement under the Outpatient Prospective Payment System...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

IP considerations in the early stages of drug development – how to pick your moment

by FPA Patent Attorneys on

The step of identifying an initial lead drug candidate is the cornerstone of the drug development process and is also usually the point at which actions are taken to protect the associated intellectual property (IP). However,...more

DOT Amends Employee Drug Testing Requirements

by Seyfarth Shaw LLP on

Seyfarth Synopsis: On November 13, 2017, the Department of Transportation amended its drug testing program regulation which, among other things, adds certain semi-synthetic opioids to its drug testing panel. ...more

White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

by Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Reckitt Benckiser LLC v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Reckitt Benckiser LLC v. Amneal Pharms. LLC, Nos. 15-2155 (RMB/JS), 15-4524 (RMB/JS), 2017 U.S. Dist. LEXIS 133998 (D.N.J. Aug. 22 2017) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Mucinex® (guaifenesin);...more

President’s Opioid Commission Issues Final Recommendations: Implications for Health Care Stakeholders

by K&L Gates LLP on

In late October, President Trump declared the nation’s opioid addiction crisis a public health emergency. Less than a week later, the President’s Commission on Combating Drug Addiction and the Opioid Crisis (the “Commission”)...more

California Enacts Limitations on Copayment Coupons

by Arnall Golden Gregory LLP on

As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a...more

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