Novartis

News & Analysis as of

Novartis and Sandoz Withdraw Zioxtenzo (pegfilgrastim) European Application

The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee for Medicinal Products for...more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

Facility Inspections Delay Sandoz's Filing For Humira Biosimilar in US

Yesterday, during its Q4 2016 earnings call, Novartis CMO Vasant Narasimhan told investors that its subsidiary Sandoz had delayed filing its aBLA for a biosimilar of Humira® (adalimumab), which originally had been planned for...more

Shearman & Sterling’s Recent Trends and Patterns in the Enforcement of the Foreign Corrupt Practices Act (FCPA)/FCPA Digest -...

Shearman & Sterling’s bi-annual Trends & Patterns in FCPA Enforcement report provides insightful analysis of recent enforcement trends and patterns in the US, the UK and elsewhere, as well as helpful guidance on emerging best...more

Sandoz: Etanercept biosimilar switch has no impact on safety and efficacy

Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved...more

Novartis AG v. Ezra Ventures, LLC

Case Name: Novartis AG v. Ezra Ventures, LLC, Civ. No. 15-0150-LPS, 2016 U.S. Dist. LEXIS 129502 (D. Del. Sept. 22, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229...more

Approval of Sandoz’s Pegfilgrastim Biosimilar May Be Delayed until at Least 2018

As we previously reported, in July the FDA issued a complete response rejecting Sandoz’s aBLA for a biosimilar of Neulasta® (pegfilgrastim). Novartis, Sandoz’s parent, indicated that that Sandoz was “working with the agency...more

Big Pharma, undeterred, racks up a half-billion dollars in regulator penalties

Big Pharma’s dubious hype of its sometimes risky products marched on last week, with the industry racking up a half-billion in regulator penalties and settlements but no seeming end to its questionable strategies and...more

First Circuit Affirms Stringent Rule 9(b) Particularity Requirement in False Claims Act Cases

On June 17, 2016, the First Circuit issued an opinion addressing, among other things, the particularity requirement that applies in False Claims Act (“FCA”) cases where the defendants are not alleged to have directly...more

Court Report - September 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey...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

Headlines from Mid-Year FCPA Enforcement Review

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

Calif. Asks Innovator Drug Brands to Do the Impossible

Eight years ago, in Conte v. Wyeth, the California Court of Appeals shocked brand prescription drug manufacturers when it held that they could be liable for injuries caused by generic versions of their medications — an...more

Breaking News – California Supreme Court To Consider Innovator Liability

We’ve always hated Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), and the whole concept of innovator liability (imposing liability on the original innovator drug manufacturer for injuries allegedly caused by a generic...more

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of...more

Court Report - May 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Hetero USA, Inc. et al. 3:16-cv-02356; filed April 26, 2016 in the...more

Dorsey Anti-Corruption Digest - April 2016

Welcome to Dorsey & Whitney’s monthly Anti-Corruption Digest. In this digest, we draw together news of enforcement activity throughout the world and aim to reduce your information overload. Our London, Minneapolis, New York...more

Court Can't Review Policy Behind Patent Term Adjustment Statute

In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon...more

Red Notice Newsletter - March 2016

ANTICORRUPTION DEVELOPMENTS – Olympus to Pay $646 Million for Anti­Kickback and FCPA Violations - Early this month, Olympus Corp. of the Americas (OCA) settled government investigations related to violations of the...more

Novartis Agrees to Settle Bribery Charges Against Chinese Subsidiaries for $25 Million

On March 23, 2015, Swiss-based pharmaceutical company Novartis AG (“Novartis”) reached a civil settlement with the United States Securities and Exchange Commission (“SEC”) for violating the internal controls and books and...more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

This Week In Securities Litigation

The Commission prevailed on a summary judgment motion this week in a case based on an offering fraud. It also filed another settled FCPA action centered on gifts, travel and entertainment provided to healthcare professionals...more

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