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Corporate Law & Governance Update - March 2017

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

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

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

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

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

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

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

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

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)

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

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