The Life Sciences industry is highly regulated and requires strong partnerships to successfully bring a product to market. As a company prepares for the approval of the FDA planning of its’ commercial supply chains will likely involve a review of the critical Contract Manufacturing Organizations (CMOs).
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The market is always fluctuating, and though some anticipated a significant market tightening in 2018 as a result of the catastrophic events that occurred at the end of 2017, the threat of a near term correction has largely dissipated.
Life sciences companies, previously considered low-value cyberattack targets because they often don’t have much easily monetized PII or PHI, avoided much of the early negative cyber publicity. That may change with the SEC’s February 2018 interpretive guidance to public companies’ cybersecurity disclosure obligations.
Recently, the U.S. Court of Appeals for the Second Circuit, applying New York law, and the U.S. Court of Appeals for the Sixth Circuit, applying Michigan law, respectively, agreed with an insured that the computer fraud provisions of a crime policy covered the loss incurred when the company’s employees transferred funds in response to a spoofed email.
At annual enrollment HR must communicate with employees and complete a variety of administrative activities in a very short time. Our 1-hour recorded webinar is designed to help HR professionals with this year’s annual enrollment process.
The purpose of this paper is to explain the basis of liability for a public company, discuss the D&O marketplace with respect to IPO exposures, and set forth what you can expect from us as your broker in the process.
One of Janet Yellen’s last acts as head of the Federal Reserve was to impose an unusual settlement condition upon Wells Fargo: as part of the consent decree, Wells Fargo would agree to the removal of four directors.
The world of cyber risk continues to develop and expand since our May 2016 paper on Medical Device Cybersecurity. The threat of ransomware has come to the forefront as demonstrated by global attacks such as Wannacry2 and Petya. These attacks show how hackers have become more sophisticated in their ability to use malware to exploit vulnerabilities in systems, hardware and devices, as well as highlighting the vulnerabilities of devices and systems that, through their lack of patching and support, and outdated operating systems, are exposed to hacking, worms, etc., that can affect patient safety, system security and data integrity.
Welcome to the winter edition of The Double Helix. Inside this issue you can find articles on the following: Medical Device Consolidation, FDA Regulations, 3D Printing and the Life Sciences Market and Clinical Trials Overseas.
Biotechnology and specifically Synthetic Biology (SynBio) is evolving at lightning speed. SynBio makes it possible to engineer life from the ground up (allowing the formation of organisms with genetic code (DNA) not found in the natural world) and to re-design existing natural bio systems for life-changing purposes. The opportunities are limitless and so are the risks.