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Biopharmaceutical firm Supernus Pharmaceuticals hit by Hive ransomware during an ongoing acquisition

Security Affairs

Biopharmaceutical company Supernus Pharmaceuticals discloses a ransomware attack, the Hive ransomware claims to have stolen company data. Biopharmaceutical company Supernus Pharmaceuticals confirmed it was the victim of a data breach after a ransomware attack that hit the firm last in Mid-November. “Supernus Pharmaceuticals, Inc.

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Merck's Success Story: Boosting Efficiency With RPA and Bots

Data Breach Today

How Merck Used Bots to Assist With Regulatory Filings in 23 Geographies Discover how Merck, a traditional global pharma giant, achieved efficiency by embracing RPA and bots for regulatory documentation. Learn how this technology revolutionized their workflow and what it mean for the future of the pharmaceutical industry.


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Paperless validation for Life Sciences projects

OpenText Information Management

Pharmaceutical organizations in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity across many documents is challenging.

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Ask Fitis, the Bear: Real Crooks Sign Their Malware

Krebs on Security

Fitis’s real-life identity was exposed in 2010 after two of the biggest sponsors of pharmaceutical spam went to war with each other, and large volumes of internal documents, emails and chat records seized from both spam empires were leaked to this author. .” Fitis’s Livejournal account. Image:

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Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier

Data Matters

On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. Background. Judgment and implications.

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Why IDMP compliance requires adaptive data governance


Pharmaceutical, biotech and medical devices firms, among others, must comply with a plethora of regulations. EMA expects pharmaceuticals to submit product data in IDMP format with a mandatory effective date of Q1 2023. The regulatory landscape in life sciences is both complex and in flux.

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Regulatory Information Management Systems: The What & the Why


Regulatory Information Management Systems/Software, or RIMS, are platforms that have emerged to assist pharmaceutical companies and medical device manufacturers in submitting products for regulatory review.