Pharmaceutical Industry

News & Analysis as of

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Your Daily Dose of Financial News

Acting SEC Chair Michael Piwowar has reportedly scaled back some of the agency’s enforcement staff’s use of delegated authority by funneling all subpoena issuance and probe initiation through the SEC’s director of...more

AGG Food and Drug Newsletter - February 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Summary of Sandoz’s Opening Brief in Sandoz v. Amgen

Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance” procedures of the Biologics Price...more

Form Drug Distribution Services Agreements May Not Be Formulaic

Vanilla-looking form agreements may contain or omit terms that are important to one or both parties. We were recently reminded of the danger of entering into form pharmaceutical distribution services agreements. Although...more

Corporate Investigations and White Collar Defense - February 2017

When Regulatory Failings Turn Criminal: Car Edition Redux - Why it matters: To paraphrase the famous quote from the film “All About Eve”: Fasten your seatbelts, it’s going to be a bumpy car ride. In the first part of...more

Shire Development LLC v. Watson Pharmaceuticals Inc. (Fed. Cir. 2017)

The Federal Circuit, in its third opinion involving ANDA litigation between these parties over Shire's LIALDA® (mesalamine) product, has apparently brought this case to a close in generic drug maker Watson's favor, in a...more

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more

International Product Liability Review - Issue 65

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. Please see full Publication below for more...more

FTC Takes Another Look at Merger Remedies

On 3 February 2017, the U.S. Federal Trade Commission (FTC) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to 2012. Nearly two decades after it issued a similar...more

Blog: Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance...more

Federal court aids in construction of provisions for third party statutory licences following temporary ceasing of a patent but...

The ground-breaking series of decisions, relating to AU 623144 (AU ‘144), which protected the antidepressant escitalopram, has generated another first when the patentee of AU ‘144 sought judicial review of a recent Patent...more

How Addressing 'The Triumvirate of Patent Risks' Can Enhance Your IP Portfolio Value

Why investors and patent owners should carefully consider the Patent Triumvirate throughout the commercial development process and beyond....more

FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court’s holding that a patent covering a chelating-agent-free drug...more

Blog: Corp Fin Suggests It Will Take A Look At Non-GAAP Disclosure Practices In The Pharmaceutical Industry

Even important industry players can sometimes run up against brick walls at Corp Fin. In a recent give-and-take with the SEC, Allergan was scolded for its use of certain non-GAAP financial measures in its press releases. ...more

Sandoz Files Opening Brief to Supreme Court in Sandoz v. Amgen

Sandoz filed its opening brief on Friday. Amicus briefs are due on February 17, and the full briefing schedule is available in our prior post....more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

Ready, Set... Cures Act Expanded Across Policy Deadline Is Almost a Go

As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available....more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

Update: Praluent® Injunction Stayed by Fed. Circuit

On February 8, the Federal Circuit issued a stay of the permanent injunction granted against the sale of Sanofi and Regeneron’s Praluent® (alirocumab). The injunction was to have become effective on February 21, 2017, but as...more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017

The Agency of Transportation has submitted a proposal to the House Transportation Committee that would allow the agency to seek damages from a utility that fails to move or adjust a utility line that is in a state or local...more

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