Pfizer

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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

New Temporary Inversion Regulations

The IRS once again is targeting inversions, and this time there have been immediate tangible results. The IRS issued temporary regulations on Monday targeting inversion transactions. An inversion occurs where a foreign...more

Your daily dose of financial news The Brief – 4.6.16

Talk about a regulation with teeth. Within days of the Treasury Department announcing new rules meant to discourage corporate tax inversion deals, Pfizer and Allergan announced they were scrapping their planned $152 billion...more

Your daily dose of financial news The Brief – 4.5.16

Big news from Big Mouse, as the former heir apparent to Bog Iger’s CEO chair—Thomas Staggs—is stepping down, throwing a wrench into Disney’s succession plans (which came under great scrutiny after a troublesome handoff to...more

The Art of the Drug Ad

Television spots touting prescription medications have flooded the airwaves for nearly 20 years. During that time, pharmaceutical companies marketing their products have become surprisingly savvy at delivering the message....more

Fourth Circuit Says Driving May Not Be Essential Job Function for Traveling Salesperson

Most employers would assume that a traveling salesperson who could no longer drive due to a medical condition cannot perform the essential functions of her job. The Americans with Disabilities Act only requires accommodations...more

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