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Investors The United States Food and Drug Administration

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

The Lawyers' Lawyer Newsletter - Halloween Issue October 2016

by Hinshaw & Culbertson LLP on

TRICK OR TREAT! The editors of the Halloween edition of the Lawyers' Lawyer Newsletter invite you to enjoy frightening tales of shocking assaults by non-clients on an unsuspecting law firm; a lawyer's nail-biting escape from...more

AGG Food and Drug Newsletter - April 2016

by Arnall Golden Gregory LLP on

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

Be Careful What You Say – Or Rather What You Don’t Say – AVEO Pays $4 Million to SEC to Settle Fraud Charges

by Sullivan & Worcester on

In March 2016, the Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based biopharmaceutical company, agreed, without admitting or denying the allegations, to pay $4 million to...more

Second Circuit Narrowly Applies Supreme Court’s Decision in Omnicare

In In re Sanofi Securities Litigation, No. 15-588-cv, 2016 U.S. App. LEXIS 4107 (2d Cir. Mar. 4, 2016), the United States Court of Appeals for the Second Circuit affirmed the dismissal of class action complaints alleging that...more

The Name Game: Institutional Investors Submit Citizen Petition Regarding Biosimilar Labeling

by K&L Gates LLP on

On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and...more

Digital Health Investments Top $2.6B* in the First Six Months of 2014

Thanks to an impressive showing in April, digital health investment in the first half of 2014 totaled $2.676 billion. There were a total of 38 deals for $20 million or more from January through June, with more than two-thirds...more

“Sophisticated Plaintiff” Found to Be Adequate Class Representative

The US District Court for the Western District of Texas certified a class of common stock purchasers in an action against Pain Therapeutics, Inc. (PTI) and its directors. The plaintiff’s complaint, which alleges that PTI...more

Digital Health: Where is the Action for Entrepreneurs? [Video]

by Fenwick & West LLP on

As CES 2013 draws to a close, Michael Esquivel, a partner in Fenwick’s Start-ups and Venture Capital Group, identifies where the action is for entrepreneurs and investors in digital health and healthcare IT. According to...more

Venture Investment in Digital Health Effectively Doubles in H1 2012

Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more

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