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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

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

Top 5 Patent Red Flags in Life Sciences Due Diligence

by JD Supra Perspectives on

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Governor Cuomo announces US$650 million life sciences funding initiative

by Dentons on

On December 19, 2016, New York Governor Andrew Cuomo announced a US$650 million life sciences initiative aimed at creating an industry and research "cluster" in New York state. The life sciences sector, generally defined as...more

Investing in Cuban Health Care Biotech Industries

by McDermott Will & Emery on

The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more

OCR Explains How Information Blocking Violates HIPAA

by McDermott Will & Emery on

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

European Health Care Compliance Challenges (And Solutions)

by Ropes & Gray LLP on

Life sciences and health care companies (“health care companies”) rightly invest a significant amount of time and money into ensuring compliance with health care regulations in the countries in which they are based, but...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

Deal Watch: Teva and Celltrion Announce Biosimilar Commercial Partnership

by Goodwin on

Teva Pharmaceutical Industries Ltd., Celltrion, Inc. and Celltrion Healthcare announced that the companies have entered into an exclusive partnership to commercialize two of Celltrion’s biosimilar candidates: CT-P10, a...more

Is your cybersecurity upgrade FDA reportable?

by DLA Piper on

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

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