Pfizer

News & Analysis as of

Pfizer to Close Australian Plant

According to BioPharma-reporter, Pfizer will close the Australian plant at which Pfizer manufactures API for HSP-130, a biosimilar version of Amgen’s Neulasta, by 2021. Pfizer will move production of the API to Croatia in an...more

Update on Ireland’s Framework Agreement

Last fall, we reported on Pfizer’s 30% price cut to Enbrel® (etanercept) to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines, which requires price reductions for off-patent branded biologic...more

First Circuit Affirms Summary Judgment for Defendant, Rejecting the Use of Aggregate Data to Prove False Claims and Clarifying the...

The First Circuit has issued an opinion affirming a complete grant of summary judgment for Pfizer, Inc. in United States ex rel. Booker v. Pfizer Inc., No. 16-1805 (1st Cir. Jan. 30, 2017), a False Claims Act (“FCA”) lawsuit...more

First Circuit affirms Pfizer victory in False Claims Act case

The First Circuit has rejected an appeal in United States ex rel. Booker v. Pfizer, a False Claims Act (FCA) case alleging that Pfizer engaged in off-label promotion of the antipsychotic drug Geodon. In its ruling on...more

Biosimilar Updates: Epoetin, Rituximab, Adalimumab

Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front...more

Competition Appeal Tribunal Refuses Interim Relief in Pharma Pricing Case

The Competition Appeal Tribunal (the “CAT”) in the UK heard on 17 January 2017 an application by Flynn Pharma Ltd and Flynn Pharma (Holdings) Ltd (together “Flynn”) to suspend the Competition and Markets Authority’s (the...more

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

RxIP Update - 2016 Year in Review

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the...more

Pfizer Announces Results from Trial With its Proposed Humira Biosimilar

Pfizer announced today that PF-06410293, its proposed biosimilar to Humira® (adalimumab), has demonstrated equivalent efficacy to Humira® in a clinical study. The clinical study gathered data from a 12 week trial in which...more

Peerless, This is Not: Sixth Circuit Finds No Latent Ambiguity in Consent to Settle Requirement in Excess Policy

Disputes between policyholders and excess insurers often involve events that occurred before the underlying defense costs or indemnity payments reached the excess layer. In Stryker Corp. v. Nat’l Union Fire Ins. Co. of...more

Year In Review: The Top-Five U.S. Market Developments of 2016

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more

Rx IP Update - December 2016

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

E-Mail Communications: The Devil is on the Server

It is hard to imagine how prosecutors were able to bring cases before there was email communications. When I was a prosecutor, we looked for evidence in a lot of other sources, internal memos, calendars and other places where...more

UK Competition Regulator Targets Big Pharma Over Excessive Pricing

Compare and contrast the current excessive pricing debates occurring in the US with those in the UK. In both markets, pharmaceutical firms are being berated for double, triple and even quadruple digit rises in the prices of...more

Success for Pfizer’s Trastuzumab Biosimilar in Phase 3 Clinical Trials

Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat...more

Don’t Underestimate the Statute of Limitations

As we hurtle into the holiday season, we are reminded that good things often come in small packages. That certainly was the case in a one-and-a-half-page opinion that the Ninth Circuit filed last week in a prescription...more

Pfizer Discontinues Development of Lipid-Lowering drug Bococizumab

Pfizer Inc. announced yesterday that it is discontinuing global clinical development of bococizumab, a monoclonal antibody inhibitor of PCSK9 that was being investigated as a lipid-lowering drug. After completing the last of...more

Pfizer to Lower Price of Enbrel in Ireland

The Irish Times reports that Pfizer will be cutting the price of Enbrel® (etanercept) on November 1st. Pfizer is cutting its price to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines (the...more

“Slack Fill” Class Action Is Empty Space

We never heard the term “slack fill” before we started writing for this blog, but it seems to be getting a lot of attention lately. We enjoyed a podcast from NPR’s Planet Money the other day discussing slack fill in black...more

ICU Medical Buys Hospira Infusion Systems From Pfizer

ICU Medical and Pfizer have reached an agreement to transfer ownership of Hospira Infusion Systems to ICU Medical, according to a joint press release on October 6....more

Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are...more

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

131 Results
|
View per page
Page: of 6
Popular Topics

"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.
×