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Corporate Law & Governance Update - January 2018

by McDermott Will & Emery on

Technology-Driven Disruption - Recent news stories and governance publications serve to underscore the challenge to health systems posed by innovation-based business model disruption. Health care boards will be expected to...more

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

OIG Scrutiny of Patient Assistance Programs

by Shipman & Goodwin LLP on

Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018. This announcement...more

FCPA Compliance Report-Episode 362-Brian Platz

by Thomas Fox on

In this episode, I visit with Brian Platz who discusses blockchain and his new company Fluree, a new Public Benefit Corporation that has introduced a scalable blockchain database for decentralized applications. ...more

Quasi Guest Post – 50 State Survey On General Jurisdiction Through Consent By Registration To Do Business: Putting Bauman And...

by Reed Smith on

What follows is a collaborative effort between Bexis and Reed Smith‘s Kevin Hara, who helped research and write this post. It’s not really a guest post, but Kevin had such a large hand in it that his contribution deserves to...more

Saudi Arabia Update – November and December 2017

by Dentons on

Legal developments - Saudi Arabia anti-corruption drive and protection of corporates - In the wake of Saudi Arabia’s headline-grabbing anti-corruption drive in November, Crown Prince Mohammed bin Salman instructed the...more

Digital Health Report - Fall 2017

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

Big Pharma BI, CBI, and Service Interruption Claims Percolating in Puerto Rico

by Zelle LLP on

As recovery and rebuilding efforts drag on in Puerto Rico, Hurricane Maria’s impact on Big Pharma is radiating across the U.S., and around the globe as the dozens of drugs manufactured in Puerto Rico become scarce. Maria...more

Health Update - October 2017

A New Look at Digital Health Business Models - Editor’s Note: The Commonwealth Fund is developing an innovative digital health advisor (DHA)—an integrated suite of digital services that would provide consumers with health...more

Alaska’s Telemedicine Business Registry: What You Need to Know

by Foley & Lardner LLP on

Alaska’s Department of Commerce, Community, and Economic Development has finalized new regulations to create a special Telemedicine Business Registry for health care providers delivering telemedicine services in the Frontier...more

Corporate Law & Governance Update - August 2017

by McDermott Will & Emery on

A new article published in the Harvard Business Review confirms that the preservation of reputation continues to be a significant motivating concern for individual board members. This is a factor that should be taken...more

New Jersey Court Rules That a Parent Company Is Still on the Hook for Divested Subsidiary’s ANDA Filing

by McDermott Will & Emery on

Addressing a motion to dismiss for lack of subject matter jurisdiction, a New Jersey district court held that Merck could maintain a Hatch-Waxman lawsuit against Actavis, Inc. n/k/a Allergan Finance LLC (Actavis), despite...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

by Knobbe Martens on

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the...more

Managing Sanctions and Export Control Risks in the Health Care Industry

by Ropes & Gray LLP on

Over the past 15 years, pharmaceutical manufacturers, medical device companies, and other participants in the health care industry have been regular targets of U.S. Foreign Corrupt Practices Act (“FCPA”) enforcement actions...more

First Circuit Holds that Scienter Requires Knowledge That Non-Disclosure Risked Misleading Investors, Not Just Knowledge of...

In Brennan v. Zafgen, Inc., — F.3d –, 2017 WL 1291194 (1st Cir., April 7, 2017), the First Circuit affirmed a District of Massachusetts decision dismissing claims against Zafgen, Inc., a biopharmaceutical developer, and its...more

Health Alert (Australia) May 1, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 21 April 2017 - ILS Rehab Pty Ltd v Josephine Borg (as administrator of the estate of the late Damien Robert Borg) [2017] NSWSC 442...more

Proskauer’s 2017 IPO Study

by Proskauer Rose LLP on

Proskauer’s Global Capital Markets Group has released its fourth annual IPO Study, a comprehensive analysis of U.S.-listed initial public offerings that priced in 2016, including an identification of IPO trends over a...more

Orphan Drug Designation

by Knobbe Martens on

“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more

Corporate Law & Governance Update - March 2017

by McDermott Will & Emery on

Executive Compensation Developments - The general counsel should anticipate questions from the board and its executive compensation committee from recent media coverage of executive compensation (especially in the...more

Deal Watch – Coherus Announces Public Common Stock Offering

by Goodwin on

Coherus BioSciences, Inc. announced yesterday that it had commenced an underwritten public offering of common stock valued at $125 million. These shares are being offered directly by Coherus in conjunction with an expected...more

Update: US Supreme Court Grants Certiorari on California Personal Jurisdiction Case

by Latham & Watkins LLP on

Nation’s highest court agrees to hear appeal of a California Supreme Court case with far-reaching implications for personal jurisdiction. In the recently published opinion in Bristol-Myers Squibb Co. v. Superior Court...more

AGG Food and Drug Newsletter - January 2017

by Arnall Golden Gregory LLP on

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

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

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