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European Health Care Compliance Challenges (And Solutions)

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

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?

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

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron...more

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015. CB Insights has released a report on the funding and deal activity within the medical device...more

GSK and Verily Partnering to Form New Bioelectronic Medicine Firm

GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Acquire Stake in Hygenia

Warburg Pincus has announced it will invest in Hygenia. Warburg Pincus, headquartered in New York, is a PE firm that takes a long-term perspective and invest in businesses at all stages of development. It invests...more

FCPA Compliance and Ethics Report-Episode 266, Ben Locwin on people v. systems approach to compliance programs [Video]

In this episode, I visit with Ben Locwin on the different approaches in compliance around people v. systems. ...more

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

Preparing for an Exit: Selling Your Robotics Company

Robots are everywhere. Healthcare, logistics, manufacturing and other critical areas of the economy are being redefined by the robotics and artificial intelligence advances of today’s technology entrepreneurs. With this...more

AGG Food and Drug Newsletter - June 2016

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

The Life Sciences Report - Summer 2016

The Future of Innovation in Medtech: An Industry in Search of Growth While Facing Pressures to Consolidate in a Post-ACA World - In the Affordable Care Act (ACA) era, the healthcare industry has witnessed significant...more

PowerPoint Slides: Could My Company's Website Violate the Americans with Disabilities Act?

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Webinar: Could My Company's Website Violate the Americans with Disabilities Act? [Video]

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Healthcare & Life Sciences Private Equity Deal Tracker: Advent to Acquire Majority Stake in ATI Physical Therapy From KRG

Advent International has announced it will acquire a majority ownership interest in ATI Physical Therapy (ATI) from KRG Capital Partners. ATI, headquartered in Bolingbrook, Ill., is a privately held healthcare company...more

Novartis Agrees to Settle Bribery Charges Against Chinese Subsidiaries for $25 Million

On March 23, 2015, Swiss-based pharmaceutical company Novartis AG (“Novartis”) reached a civil settlement with the United States Securities and Exchange Commission (“SEC”) for violating the internal controls and books and...more

High-flying drug firms, CEOs take a fall — will price profiteering falter, too?

Although they may have been high-flyers just a few months ago, some big players in Big Pharma have gotten a brutal kind of karmic comeuppance for their craven business strategy of jacking up drug prices to maximize profits,...more

Blog: Why Entrepreneurs Should Care About the FCC

You’re an entrepreneur developing cutting edge technology, so why should you care about the Federal Communications Commission? If you think the FCC only regulates broadcasters and old-time telephone and cable companies, the...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

Acquittals in Vascular Solutions Case Deal Setback to DOJ

On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow...more

HeartWare Cancels $930M Deal with Valtech Cardio

HeartWare International, Inc. has announced that it will not longer proceed with its previously announced deal to acquire Valtech Cardio, Ltd. Valtech is a privately held Israeli company developing transcatheter mitral and...more

Healthcare tech meets healthcare reality

As entrepreneurs rush into the healthcare sector, even the most innovative thinkers are encountering a unique set of challenges – and solving them will require every bit as much ingenuity as building groundbreaking new...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

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