News & Analysis as of

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

BREAKING NEWS: Pfizer Announces Upcoming U.S. Launch of Biosimilar INFLECTRA® (infliximab-dyyb)

Pfizer announced today that it will begin shipping INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE® (infliximab), to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA® received FDA...more

The End of the Road for Pro Se Neurontin Plaintiff with No Evidence of Causation

This past weekend, we paid a return visit to Cleveland, the home of our best law school friend, who braved the (figurative) waters of New Haven with us so many years ago. In deference to the Drug and Device Law Traveling...more

Viagra — Developments in Litigation

There have been some very recent developments in the national litigation regarding the erectile dysfunction (ED) drug Viagra and the allegation that its use increases a patient’s risk of developing melanoma. Judge Seeborg,...more

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...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

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

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

Pfizer Inc. v. Sandoz Inc

Case Name: Pfizer Inc. v. Sandoz Inc., C.A. No. 13-1110-GMS, 2016 U.S. Dist. LEXIS 52762 (D. Del. Apr. 20, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate); U.S. Patents Nos....more

Amicus Briefs in Support of Sequenom's Petition for Certiorari: Eli Lilly and Company et al.

In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v....more

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

Your daily dose of financial news The Brief – 6.1.16

All of us are entitled to a change of heart. But when you’re one of the world’s most famous activist investors and the change involves a decent-sized stake in a drug maker (Allergan) that just 5 months ago was mixed up with a...more

Your daily dose of financial news The Brief – 5.17.16

Gannet’s still after Tribune Publishing, and it’s upped its ante after Tribune “resoundingly rejected” early overtures – NYTimes... The Journal walks us through the fall of the Laplanche empire at Lending Club with a...more

New "Inversion" Proposed Regulations Inspired By The Pfizer/Allergan Deal May Impact Corporate Tax Planning Strategies

The Treasury Department has recently promulgated proposed regulations dealing with so-called inversion transactions. Inversion transactions are ones in which a U.S. corporation changes its domicile to a nation with a more...more

Your daily dose of financial news The Brief – 5.11.16

The fallout from Lending Club’s surprise news about Renaud Laplanche’s departure continues, with Goldman Sachs and Jeffries LLC hitting the pause on planned LC bond sales – WSJ... A Treasury Department white paper...more

Lawsuits over Viagra Melanoma Risk Mounting

The Judicial Panel on Multidistrict Litigation heard arguments at a hearing on March 31, 2016, about the need for national coordination of Viagra claims. Pfizer, the manufacturer of Viagra, did not oppose this request by the...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

Court Report - April 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories, LLC et al. v. Amerigen Pharmaceuticals, Inc. et al. 1:15-cv-00966; filed October 23, 2015 in the...more

Second Circuit Stresses Control, Not Attribution, In Applying Janus’s “Ultimate Authority” Test, And Also Allows Expert Testimony...

In Janus Capital, the Supreme Court established the “ultimate authority” test to determine who may be liable under Section 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”) as a “maker” of a materially misleading...more

Court Report - April 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC 1:15-cv-00964; filed October 22, 2016 in the District...more

FDA Announces Approval of Second U.S. Biosimilar

On April 5, the FDA issued its approval for Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab). Inflectra is now the second biosimilar approved for sale in the United States, after...more

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

Proposed Regulations Would Fundamentally Change Treatment of Intra-Group Debt Transactions

On April 4, 2016, the U.S. Department of the Treasury and Internal Revenue Service (IRS) issued two sets of regulations, temporary regulations addressing “inversion” transactions and proposed regulations regarding the...more

Your daily dose of financial news The Brief – 4.8.16

The Deal Professor looks back on a wild week of “deal busting” that saw the government [often in the form of Treasury Secretary Jack Lew] put the hurt on Pfizer/Allergan and Halliburton/Baker Hughes alike –...more

Your daily dose of financial news The Brief – 4.7.16

The DOJ has moved to block the proposed Halliburton/Baker Hughes merger in a Delaware-based federal lawsuit that argues that “combining the two oil field services companies would cut competition in the industry to...more

110 Results
View per page
Page: of 5
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.