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Pfizer

Pfizer Gets Second CRL On Proposed Epoetin Alfa Biosimilar

by Goodwin on

According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha)....more

Consolidated Cholesterol Drug Cases Lack Critical Mass for CAFA Jurisdiction

by Carlton Fields on

The Central District of California district court recently weighed in on the limits of mass action jurisdiction under the Class Action Fairness Act (CAFA). The matter began as various individual state court actions alleging...more

Biosimilars Update -- Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval

On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen...more

Pfizer files two IPR petitions on Genentech’s Patent Directed to Methods of Making Humanized Antibodies

by Goodwin on

Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized...more

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...more

Pfizer Files Two Petitions for IPR of Chugai Pharmaceutical’s Protein Purification Patents

by Goodwin on

Pfizer, Inc. has filed two petitions for IPR of Chugai Pharmaceuticals’s patents: IPR2017-01357 on U.S. Patent 7,332,289 and IPR2017-01358 on U.S. Patent 7,927,815. According to the petitions, both patents are directed to...more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Pfizer Files for IPR of Two Biogen Patents Directed to Rituximab

by Goodwin on

In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the...more

Federal Court of Appeal dismisses Teva’s appeal relating to utility and sufficiency

by Smart & Biggar on

On March 14, 2017, the Federal Court of Appeal (FCA) dismissed Teva’s appeal of Locke J.’s Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva in respect of its calcipotriol and...more

PTAB Institutes Two IPRs in Hospira v. Genentech Avastin Dispute

by Knobbe Martens on

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in...more

Pfizer to Close Australian Plant

by Goodwin on

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

by Goodwin on

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...

by Ropes & Gray LLP on

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

by DLA Piper on

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

by Goodwin on

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

by Latham & Watkins LLP on

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

by Smart & Biggar on

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

by Reed Smith on

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

by Goodwin on

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

by Carlton Fields on

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

by Goodwin on

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

by Smart & Biggar on

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

by Michael Volkov on

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

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