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AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) 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...more

Indiana Medical Device Manufacturer’s Deferred Prosecution Agreement with DOJ Extended for a Second Time

On March 25, an Indiana-based medical device manufacturer announced that the deferred prosecution agreement it entered into with the DOJ to settle FCPA charges in 2012 would be extended a second time. The company reported...more

Pharmaceutical Company Settles with SEC Regarding FCPA Offenses in China

On March 23, the SEC announced that it settled FCPA allegations with a Switzerland-based pharmaceutical company, via a cease and desist order finding that the company violated the FCPA’s book and records and internal controls...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

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

AGG Food and Drug Newsletter - February 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

Merck Resolves Investors’ Class Action Lawsuit Related To Vioxx

In 2004, Merck pulled its painkiller, Vioxx, from the market after a study linked the drug to increased risks for heart attack and strokes. On Friday, January 15, 2016, Merck announced that it had agreed to pay $830 million...more

Healthcare & Life Sciences Private Equity Deal Tracker: Scholar Rock Secures $36 Million in Funding

Scholar Rock, based in Cambridge, Mass., is a biotechnology company focused on developing drugs that selectively target supracellular activation of growth factors in the disease microenvironment. The company’s initial drug...more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Invest up to $300 Million in Vertice Pharma

Vertice Pharma, which has its U.S. headquarters in New Jersey, will focus on acquiring specialty pharmaceutical companies and products. It was launched by pharmaceutical industry veterans Don DeGolyer and Andrew Saik in...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Penumbra Files for $115 million IPO

Alameda, California-based medical device company Penumbra, Inc. registered with the Securities and Exchange Commission (SEC) last Friday for an initial public offering (IPO) to raise up to $115 million. The company will be...more

The Supreme Court Addresses Scope of Section 11 Liability for Statements of Opinion

As the Supreme Court recently explained in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S. Ct. 1318 (2015), that distinction is significant when it comes to liability under Section 11 of...more

Acelity Reported to Plan $1 Billion IPO

San Antonio, Texas based medical device company Acelity LP Inc. is reported to be considering an initial public offering that could raise up to $1 billion, according to the Wall Street Journal. Acelity has reportedly...more

Expect Focus - ONLINE HEALTH CARE: NOT SO FAST Telemedicine Hits A Few Speed Bumps, Volume II, Spring 2015

In This Issue: - IN THE SPOTLIGHT • Risky Business: Common Cyber Security Risks, Expensive Consequences - LIFE INSURANCE • Ninth Circuit Finds Bonus Indexed Annuity Delivers Exactly...more

Insurance Recovery Law - May 2015 #2

Recent Lawsuit Underscores Critical Lessons for Purchasers of Cyber Insurance - Why it matters: Columbia Casualty Company v. Cottage Health Systems was filed on May 7, 2015, in the Central District of California. Cottage...more

Software Company to Face Suit Over Contract Restructuring

The United States District Court for the Northern District of California sustained a securities fraud complaint alleging that the defendants, a software company and its executives, had defrauded investors by failing to...more

Fourth Circuit Sustains Securities Fraud Claim Against Drug Manufacturer

On March 6, the US Court of Appeals for the Fourth Circuit found that the United States District Court for the Western District of North Carolina had erred in dismissing a class action lawsuit filed under Section 10(b) of the...more

Omnicare: Section 11 Liability and Opinions

The Supreme Court defined the circumstances under which liability can be imposed for opinion statements under Securities Act Section 11. Specifically, the Court held that such liability could be imposed on two theories: One...more

2015 IPO Study

In this Issue: - Executive Summary - 2014 Overview - Year-Over-Year Analysis - Health Care - Technology, Media & Telecommunications - Energy & Power - Financial Services - Industrials -...more

Privacy & Cybersecurity Update - February 2015 (Updated)

In This Issue - White House Releases Proposed Privacy Legislation - Lessons from the Anthem Data Breach - SEC and FINRA Release Results of Industrywide Cybersecurity Examination Sweeps - COSO Releases Report on...more

State Of The Union “Sneak Peek” Highlights Administration Cybersecurity Initiatives

As part of a series of “sneak peeks” announced in advance of the State of the Union address on Tuesday, January 20th, President Obama made remarks last week before the Federal Trade Commission, the Department of Homeland...more

Blog: Cyberthieves Collect Confidential Information, Apparently To Conduct Insider Trading

Here is an unnerving warning from FireEye, a cybersecurity firm, discussed in this article from MarketWatch, regarding a sophisticated, native-English-speaking group, designated FIN4, that has targeted almost 100 public...more

California Healthcare Institute Releases 2015 California Biomedical Industry Report

The California Healthcare Institute and PricewaterhouseCoopers, LLP have released their 2015 California Biomedical Industry Report describing industry trends through 2014. The CHI report highlights the continued strength of...more

Outrageous Opinions in Registration Statements

In Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, No. 13-435, the respondents fired back at the petitioners in a brief filed with the Supreme Court, posing a simple question: “Whether...more

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