Pfizer

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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

Is Driving An “Essential Function Of The Job” For Your Road Warriors?

If your employee isn’t a professional driver but spends a lot of time on the road, how “essential” a job function is driving for ADA purposes? Is driving “essential” at all? In what I consider to be a very significant...more

Time Between Original and Corrected Restriction Requirement Nets No Further Patent Term Adjustment (Pfizer, Inc. v. Lee)

Addressing patent term adjustment issues, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. Patent and Trademark Office’s (USPTO) decision not to adjust the term of a patent, where the 197-day delay resulted...more

Blog: Director Resignation Policies Under Fire

The originator of the “Pfizer model” of “plurality plus” voting for directors — Pfizer — will be facing a shareholder proposal (January 29, from the Chevedden folks) calling for a change to Pfizer’s governing documents and...more

Viagra — Melanoma Lawsuits Mounting

The Judicial Panel on Multidistrict Litigation will hold a hearing to consider a request to establish coordinated national litigation against the manufacturers of Viagra. The Judicial Panel is a group of federal judges who...more

Pfizer, Inc. v. Lee (Fed. Cir. 2016)

Last month, in Pfizer, Inc. v. Lee, the Federal Circuit determined that the District Court for the Eastern District of Virginia did not err in granting summary judgment in favor of the U.S. Patent and Trademark Office on the...more

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

Pfizer v. Lee: A Patent Term Adjustment Double Standard?

In Pfizer v. Lee (No. 2015-1265, January 22, 2016), the Federal Circuit upheld the U.S. Patent and Trademark Office’s (USPTO) determination that the toll period for A-type patent term adjustment (PTA) delay stops upon the...more

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