Pharmaceutical Industry

News & Analysis as of

Court Report - August 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Elizabeth LLC et al. 1:16-cv-00603l; filed July 12, 2016 in the District Court of...more

Romanian tax authorities go public on the first VAT fixed establishment assessment in the pharmaceutical industry

The Romanian tax authorities just issued a press release regarding an audit performed on the activity carried out by the local subsidiary of a multinational pharmaceutical group. The Romanian authorities claim that this...more

HHS Proposes 340B Dispute Resolution Process

From its inception the 340B program has been the subject of disputes between drug manufacturers and their safety-net hospital customers. On August 12 HHS proposed an administrative process for resolving those...more

District Court Narrowly Defines the Relevant Market in Post-Actavis Pay-For-Delay Suit

On August 8, the District of Connecticut issued a noteworthy ruling on how to approach defining the relevant market definition in a pay-for-delay suit. In In re Aggrenox Antitrust Litigation, 3:14-md-02516 (D. Conn.), three...more

OIG Highlights Varying Local Medicare Part B Drug Coverage Policies; Recommends Single Entity to Make Drug Coverage Determinations

The OIG has issued a report entitled “MACs Continue to Use Different Methods to Determine Drug Coverage,” which reviews how Medicare Administrative Contractors (MACs) make Medicare Part B drug coverage determinations and...more

The Effect of Patents and Drug Price Regulation on New Drug Diffusion Globally

One of the great benefits of scientific inquiry is the capacity for presumptions and prejudices from experience to be challenged and explained in ways that are counter-intuitive. This is true even for disciplines like...more

Manatt on Health Reform: Weekly Highlights - August 2016 #4

HealthCare.gov plans an open enrollment pilot that will let consumers compare provider network breadth; new Medicaid enrollees reduce out-of-pocket spending on prescription drugs by nearly 60%; and Kansas’s Governor announces...more

The Marijuana Industry’s Big Win: The DEA’s Refusal to Reschedule

Earlier this year, when the U.S. Drug Enforcement Agency (DEA) indicated it would have an announcement regarding a now five-year-old petition to reschedule cannabis, numerous industries on the “outside looking in” were...more

What's in a Name? A Quick Guide to Biologic Drug Names

We have previously reported on the complicated naming issues surrounding biosimilar products and how biological qualifiers, such as three or four-letter codes, should be added to distinguish between them. However, the...more

FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

Your daily dose of financial news - The Brief – 8.23.16

The 2d Circuit has refused the DOJ’s motion for reconsideration of the panel’s May decision overturning a jury verdict and accompanying $1.27 billion fine against Bank of America over its “Hustle” mortgage generation program....more

AGG Food and Drug Newsletter - August 2016

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

PTAB Life Sciences Report

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents....more

Your daily dose of financial news - The Brief – 8.22.16

The SEC’s opened an inquiry into Hampton Creek in response to a Bloomberg report that the Just Mayo maker used undercover contractors to purchase its non-egg mayonnaise product in bulk not long before HC raised $90 million...more

Manatt on Medicaid: Medicaid: States’ Powerful Tool to Combat the Opioid Crisis

Editor’s Note: The United States is in the throes of a rapidly worsening opioid epidemic. The crisis is far-reaching: As of 2014, 1.9 million Americans had an opioid use disorder involving prescription medication, and an...more

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more

Drug Companies and Charitable Patient Foundations

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

Survey Suggests Pharmacists Prefer Non-Proprietary Proper Names for Biosimilars

The August, 2016, edition of the Journal of Managed Care & Specialty Pharmacy published the results of a survey designed to measure pharmacists’ view on biosimilar naming conventions. (See our previous posts here and here...more

Biosimilars Development Updates

According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70%...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

Amgen v. Hospira: Amgen’s Appeal to the Fed. Cir. Will Proceed on the Merits

As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to...more

Helsinn Healthcare S.A. v. Hospira, Inc.

Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...more

InSeal Medical Receives CE Mark for Vascular Closure Device

InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood...more

JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more

2,517 Results
|
View per page
Page: of 101
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×