Glenn Engelmann

Glenn Engelmann

McDermott Will & Emery

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Inside M&A - Summer 2014

“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A" - More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides...more

5/30/2014 - Best Efforts Clauses Biotechnology Commercially Reasonable Efforts Contingent Payment Clauses Good Faith Life Sciences Medical Devices Milestone Payments Pharmaceutical Popular

FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance,...more

3/10/2014 - FDA Medical Devices Off-Label Use Pharmaceutical Prescription Drugs

China Compliance Update: Commercial Bribery Risks Remain Very Real in China

The enactment of new legislation, as well as new and continuing investigations, demonstrates that Chinese regulators have not slowed down their efforts to ferret out corruption in the pharmaceutical sector and related...more

2/13/2014 - Bribery China Compliance Foreign Official White Collar Crimes

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

1/29/2014 - Biologics FDA Internet Marketing Prescription Drugs

New Law Extends Federal Oversight of Compounding Pharmacies, Establishes National Drug Track-and-Trace Requirements

On November 27, 2013, President Obama signed the Drug Quality and Security Act (the Act) (Public Law No. 113-54) into law. The Act addresses two hot-button issues relating to marketed drug products: the extent of federal...more

1/22/2014 - Drug Compounding FDA Pharmaceutical Pharmacies Prescription Drugs

Whistleblowing in China and the United States

The Chinese Government’s wide-ranging bribery and corruption investigation into the pharmaceutical industry takes a new turn every week. Media reports contain numerous incidents of purported whistleblowers making allegations...more

8/30/2013 - Bribery China Compliance Corruption Dodd-Frank False Claims Act Pharmaceutical Risk Management Whistleblower Awards Whistleblowers

Observations on a Milestone Bribery Investigation and Increased Scrutiny of Foreign Companies in China

The Chinese government’s recent crackdown on alleged bribery and corruption of local officials by multinational pharmaceutical companies could signal a broad trend toward elevated scrutiny of all foreign corporations...more

7/30/2013 - Bribery China Compliance Corruption Due Diligence FCPA Foreign Corporations GlaxoSmithKline UK Bribery Act

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

5/7/2013 - Biosimilars FDA Fees Meet and Confer Sponsors

Supreme Court Hears Oral Argument in "Pay-for-Delay" Patent Settlement Antitrust Case

The Supreme Court’s ruling in Federal Trade Commission v. Actavis, Inc., will almost certainly have major implications for the viability of Federal Trade Commission and private suits alleging that pay-for-delay settlements...more

3/27/2013 - FTC Generic Drugs Infringement Patents Pay-For-Delay Pharmaceutical SCOTUS Settlement

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more

12/11/2012 - FDA Off-Label Promotion Pharmaceutical

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