Pharmaceutical Manufacturers

News & Analysis as of

IPR Update -- The First Pharma IPR Decisions

Late last month, while many of us were getting ready to attend the BIO International Convention in San Diego, the Patent Trial and Appeal Board ("Board") issued four related inter partes review opinions, marking what many...more

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

Teaching Hospitals and Physicians Must Take Action Now to Correct Erroneous Reports about them Submitted Under the Sunshine Act

On September 1, 2014, the Centers for Medicare and Medicaid Services (CMS) will make public the reports submitted by pharmaceutical and medical device manufacturers under the Sunshine Act. These reports will disclose...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

Daubert Déjà Vu

Plaintiff’s expert is excluded for relying on a “novel” methodology to support opinion that antidepressant drug causes birth defects. - On June 27, 2014, in In Re: Zoloft, U.S. District Judge Cynthia Rufe of the...more

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

Settlement Over Deceptive Implant Marketing

Johnson & Johnson (“J&J”) has reached a four million settlement with the state of Oregon to resolve allegations that J&J improperly marketed its DePuy ASR metal-on-metal hip implants. J&J has recalled 93,000 ASR hip...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Hospitals Urging SCOTUS to Limit False Claims Act Penalties

What do a moving company and a hospital association have in common? The False Claims Act (FCA). The American Hospital Association along with the United States Chamber of Commerce and the Pharmaceutical Research and...more

Meso Scale Diagnostics, LLC v. Roche Diagnostics GMBH, C.A. No. 5589-VCP (Del. Ch. June 25, 2014) (Parsons, V.C.)

In this post-trial memorandum opinion, the Delaware Court of Chancery dismissed plaintiffs’ breach of contract claim with prejudice, finding that plaintiffs failed to establish they were parties to the License Agreement at...more

FDA Draft Guidance - Best Practices for Developing Drug Trademarks

In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Coolness in Being the Bad Guy? Eli Wallach and GSK

Eli Wallach died Tuesday. For my money, he was about the coolest bad guy out there. Not tough like Lee Marvin, just cool. My favorite Wallach roles were as Calvera in The Magnificent Seven and as Tuco in The Good, The Bad and...more

GSK Faces a Bad Day at Black Rock

One of my favorite movies is Bad Day at Black Rock. It is one of the few movies to combine elements of film noir into something approaching a traditional Western. It also attacks directly the prejudice and hate against...more

Connected Health: Capturing Digital Opportunities

Her comment has been echoed by many market participants who have predicted that we are seeing the first wave of large traditional companies leveraging digital platforms and tools to drive growth and innovation. These...more

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v....more

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

Court Report - June 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cephalon Inc. v. Breckenridge Pharmaceutical Inc. et al. 1:14-cv-00671; filed May 27, 2014 in the District Court of...more

340B Drug Discount Program Orphan Drug Rule Vacated: ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs...

The D.C. District Court permanently enjoined the U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan...more

HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs...more

Sunshine Act/Open Payments Alert

On Monday, May 5, 2014, CMS published in the Federal Register an unexpected notice seeking additional public comment specifically around the Dispute Resolution process, which is the process CMS is establishing to give...more

Update on the Provider Self-Disclosure Protocol

Since we last reported on the Provider Self-Disclosure Protocol (“Protocol”) issued by the Department of Health and Human Services, Office of the Inspector General (“OIG”), the entire Protocol has been revamped. Rather than...more

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