Pharmaceutical Industry

News & Analysis as of

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

Naming of Interchangeable and Biosimilar Biological Products Likely to Be Same

Earlier this fall, FDA issued a draft guidance proposing a middle-road approach to naming biosimilars. Unlike small-molecule drugs, where the branded and generic drug share the same nonproprietary name (also referred to as a...more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Invest up to $300 Million in Vertice Pharma

Vertice Pharma, which has its U.S. headquarters in New Jersey, will focus on acquiring specialty pharmaceutical companies and products. It was launched by pharmaceutical industry veterans Don DeGolyer and Andrew Saik in...more

Lessons to keep in mind for your next complex global deal

Antitrust assessment by regulators around the world is becoming increasingly more complex and less predictable. And with global M&A activity approaching boom levels, companies need to plan carefully when preparing for their...more

FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits...more

Alert: China Piloting Drug Marketing Authorization Holder System

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

Patent Infringement Safe Harbor and Importation Redefined: Ruling Incentivizes Generic Pharmaceutical Offshore Product Testing

A recent ruling by the U.S. Court of Appeals for the Federal Circuit has provided an apparent loophole for manufacturers to avoid infringement liability for conducting patented manufacturing quality control steps offshore. On...more

Generic Preemption Prevails in Testosterone MDL

What? You were expecting another of our insensitive blogpost headlines? Nope, we’re playing this one straight down the middle. In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286...more

Life lines: Life sciences M&A and the rise of personalised medicine

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Manatt on Health Reform: Weekly Highlights - November 2015 #2

With the election of a new Governor, the future of Kentucky’s Marketplace and Medicaid expansion is uncertain; CMS questions Iowa on its Medicaid managed care transition timeline; and the Supreme Court agrees to hear a case...more

Allergan Acquires AqueSys for $300 Million

Allergan recently announced that it has completed its acquisition of AqueSys. AqueSys is a privately held company, headquartered in Orange County, California, focusing on “commercializing implantable devices that will...more

Health Alert (Australia) - November 9, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Queensland 13 October 2015 - Chaudhry v Medical Board of Australia [2015] QCAT 414 The Queensland Civil and...more

Update on Health Canada's Modernization Makeover: Proposed Changes to Labelling Standards for Products Containing Acetaminophen

Health Canada is in the midst of a “modernization makeover.” The Agency is undertaking a multi-year, comprehensive review of its regulatory frameworks for health products and food. Among other things, modernization efforts...more

New Preemption Decisions That We Can't Discuss Quite Yet

As lawyers, we have to get client approval before we can discuss their litigation substantively. Here are a couple just-in decisions where we’re doing that, but that are important enough our readers would want to know about...more

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s...more

Claims Are Construed In Pharmaceutical Case

Sleet, J. Claim construction opinion issues regarding one term from two patents. The following term was considered: - “treatment for HVC”...more

Punitive Damages – How Much Increased Risk Is Enough?

Back in 2009 – when the blog was still a Bexis/Herrmann operation – we wrote a catch-all punitive damages post entitled (oddly enough) “On Punitive Damages.” That post identified and briefly discussed a variety of punitive...more

Warnings Causation Sinks "Failure to Update" Claim

This post is not from the Dechert side of the blog. “Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

FDA Rejects Hospira’s EPO Biosimilar Application

After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S....more

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

Apotex Follows the BPCIA “Patent Dance” Again

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

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