Drugs

Focus on Cybersecurity and IP Asset Protection: Foley

A Foley online white paper, “Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Device Industries,” is intended to help industry members focus on cybersecurity and intellectual property asset issues in an accessible and practical way. The guidebook says that for life science and medical device companies it is “mission critical to protect lab books, drug and clinical test data, product formulas, and production processes that underlie a company’s patents, trade secrets, and know-how from hackers and others. Given the interconnectivity of corporate data networks, it has become all too easy for cyber thieves to gain access to valuable information in a network and monetize hard-earned IP or cause a company reputational or financial harms.”

The paper lists six key steps for protecting a company’s proprietary data and IP assets:

identify and data map IP assets within physical and digital systems, on-site and in the cloud, and those in the hands of remote vendors and clinical researchers;
be aware of and implement contractual, physical, and digital security systems to protect IP assets;
become aware of cybersecurity risks and implement basic security rules of the road and effective security policy programs to protect IP assets;
conduct constant risk assessments and evaluate and simulate how best to protect the company and its stakeholders in the event of a system and data breach;
be aware that the Internet of Things and remote medical devices exponentially increase cybersecurity risks down to the device level; and
be aware of the legal framework to protect the confidentiality of IP assets, as well as the liability and regulatory framework affecting cybersecurity in the life sciences and medical devices sectors.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome