Office of Criminal Investigations

George Mason's TraCCC Fight Counterfeiters with Second Annual Hackthon

Retrieved on: 
Thursday, October 26, 2023
Sale, Crime, Social media, Office of Criminal Investigations, Transnational, GMU, Government, Seumas McNally Grand Prize, EST, George Mason University, Research, Terrorism, Transnational Crime and Corruption Center, Demo, Private sector, CINA, IP, Prize, Drug

WASHINGTON, Oct. 26, 2023 /PRNewswire/ -- George Mason University's Terrorism, Transnational Crime and Corruption Center is gearing up to host a second annual Bring Down Counterfeiting Hackathon "Demo Day" on Saturday, November 4 at GMU's Arlington Campus. Organized by Blue Clarity, the hackathon event brings academia, government, private sector, and techies together to brainstorm novel solutions to fight counterfeiting and protect intellectual property rights. Hackathon participants have spent weeks devising innovative technical solutions that combat the sale of counterfeit products on e-commerce sites and social media, support government agencies in this fight, or help protect IP rights holders. Final submissions are due October 29, 2023 at 11:59 pm EST.

Key Points: 
  • WASHINGTON, Oct. 26, 2023 /PRNewswire/ -- George Mason University's Terrorism, Transnational Crime and Corruption Center is gearing up to host a second annual Bring Down Counterfeiting Hackathon "Demo Day" on Saturday, November 4 at GMU's Arlington Campus.
  • Organized by Blue Clarity , the hackathon event brings academia, government, private sector, and techies together to brainstorm novel solutions to fight counterfeiting and protect intellectual property rights.
  • Hackathon participants have spent weeks devising innovative technical solutions that combat the sale of counterfeit products on e-commerce sites and social media, support government agencies in this fight, or help protect IP rights holders.
  • We are thrilled to work again this year with the amazing people at TraCCC to take on the challenge of combating counterfeiting."

PROCEPT BioRobotics® Receives U.S. FDA Investigational Device Exemption to Investigate Aquablation® Therapy for Prostate Cancer

Retrieved on: 
Tuesday, September 12, 2023
Office of Criminal Investigations, Medicine, BPH, Quality of life, Research, USC, NYU Langone Health, Patient, Investigational device exemption, Keck School of Medicine of USC, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Prostate cancer, Pharmaceutical industry, Aquablation therapy, Urology

REDWOOD CITY, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics Corporation (NASDAQ: PRCT) (“PROCEPT BioRobotics”), a global leader in surgical robotics, announced today the Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to investigate the safety and efficacy of Aquablation therapy for prostate cancer.

Key Points: 
  • REDWOOD CITY, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics Corporation (NASDAQ: PRCT) (“PROCEPT BioRobotics”), a global leader in surgical robotics, announced today the Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to investigate the safety and efficacy of Aquablation therapy for prostate cancer.
  • The study will enroll patients with localized prostate cancer at three prestigious cancer centers, Keck Medical Center of USC, Perlmutter Cancer Center at NYU Langone Health, and Mount Sinai Tisch Cancer Center.
  • “Aquablation Therapy, recognized for its efficacy and safety in resecting prostate tissue for BPH, offers a potential paradigm shift in how urologists might address localized prostate cancer.
  • Reza Zadno, CEO of PROCEPT BioRobotics, remarked, "Receiving IDE approval to explore Aquablation Therapy for men with localized prostate cancer marks a pivotal moment for PROCEPT.

Femasys Inc. Announces Financial Results for the Second Quarter Ended June 30, 2023 and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Patent, Insurance, Investigational device exemption, Office of Criminal Investigations, Research and development, Marketing, Public Health Agency of Canada, Woman, Audit committee, Anesthesia, IDE, FDA, Therapy, Health Canada, Pregnancy rate, Public Health Agency, First Ever, Safety, Nursing, Pharmaceutical industry, Cryptocurrency

ATLANTA, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • Femasys expects the resulting patent, when issued, will have an anticipated expiration in 2039 at the earliest.
  • Sales increased by $17,401 to $320,514 for the three months ended June 30, 2023 compared to $303,113 for the same period in 2022.
  • Gross margin percentage was 65.5% for the three months ended June 30, 2023 as compared to 66.2% for the three months ended June 30, 2022.
  • Gross margin percentage was 64.9% for the six months ended June 30, 2023 as compared to 64.0% for the same period in 2022.

Revolution Medicines, Inc. to Acquire EQRx, Inc. in All-Stock Transaction to Gain More Than $1 Billion in Additional Capital

Retrieved on: 
Tuesday, August 1, 2023
Pancreatic cancer, Revolution, LLP, Office of Criminal Investigations, AACR, ESMO, Development of the human body, Research, Latham & Watkins, NSCLC, Goldman Sachs, Lung cancer, Movement, Cancer, Acquisition, RAS, Patient, OFF, European Society for Medical Oncology, Triple, IND, Guggenheim Partners, Conference, Pharmaceutical industry

REDWOOD CITY, Calif. and CAMBRIDGE, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (“Revolution Medicines” or the “Company”) (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, and EQRx, Inc. (“EQRx”) (Nasdaq: EQRX) today announced a definitive agreement through which Revolution Medicines plans to acquire EQRx in an all-stock transaction intended to add more than $1 billion in net cash to Revolution Medicines’ balance sheet. The total number of shares of Revolution Medicines common stock to be issued to EQRx security holders will be determined in close proximity to the closing of the stockholder votes on the transaction based on the formula described below (see Transaction Details section). The deal, which was overseen by independent committees of Revolution Medicines’ and EQRx’s respective boards of directors, has been approved by the directors of each company. The transaction, which is subject to customary closing conditions, will enhance Revolution Medicines’ efforts to fulfill its vision to discover, develop and deliver pioneering RAS(ON) Inhibitor drugs on behalf of patients with RAS-addicted cancers.

Key Points: 
  • The deal, which was overseen by independent committees of Revolution Medicines’ and EQRx’s respective boards of directors, has been approved by the directors of each company.
  • Revolution Medicines’ acquisition of EQRx reflects both companies’ confidence in Revolution Medicines’ ability to deploy this amount of capital effectively.
  • At the close of the transaction, one EQRx director will be designated by Revolution Medicines to serve on its board of directors.
  • A live webcast of the call will also be available on the Investors section of Revolution Medicines’ website at https://ir.revmed.com/events-and-presentations .

The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway

Retrieved on: 
Thursday, May 18, 2023
Surgery, Health, FDA, Medical Devices, Robotics, Technology, Clinical Trials, Other Technology, Investigational device exemption, Office of Criminal Investigations, De novo, Multimedia, History, Trial of the century, RAS, Patient, MIRA, IDE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

Virtual Incision Corporation today announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Virtual Incision Corporation today announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA).
  • The submission seeks authorization to market the MIRA Surgical System for use in bowel resection procedures and comes on the heels of Virtual Incision’s completed Investigational Device Exemption (IDE) clinical study.
  • “If we are successful with our submission, the FDA De Novo pathway will establish MIRA in a brand-new medical device category of miniaturized RAS.
  • In the longer term, the objective is to enable wide adoption in any healthcare facility for any patient undergoing abdominal surgery.

International SOS Hires Former Boeing Company VP And Chief Security Officer As New Security Advisor

Retrieved on: 
Thursday, January 26, 2023
Technology, Other Defense, Security, Military, Professional Services, Government Technology, Environmental, Social and Governance (ESG), Other Professional Services, Defense, Overseas, TSA, Office of Criminal Investigations, Sony Pictures, Organization, U.S. Immigration and Customs Enforcement, International SOS, Government, United States Department of State, Threat, Assistant, United States Customs Service, Travel, The Coca-Cola Company, Boeing, Terrorism, DHS, National Security Advisor (India), Food, Health, Senior, Security Service, Naval Criminal Investigative Service, Intelligence, FBI, Information Committee, Diplomatics, Policy, Knowledge, Domestic Security Alliance Council, International, Crime, United States Department of Homeland Security, SOS, Domestic, United States International Programming to Ukraine and Neighboring Regions, Regulation of tobacco by the U.S. Food and Drug Administration, United States Department of the Army, Immigration, Airline, Management

International SOS has announced today that they have hired retired Vice President and Chief Security Officer of The Boeing Company, Dave Komendat, as their new Senior Security Advisor.

Key Points: 
  • International SOS has announced today that they have hired retired Vice President and Chief Security Officer of The Boeing Company, Dave Komendat, as their new Senior Security Advisor.
  • “International SOS is known for providing the most high-quality health and security care to its clients, and I’m pleased to join this team,” said Dave Komendat, Senior Security Advisor at International SOS.
  • “Dave is among the best of the best in the security industry,” said Jarrett Michau, Chief Executive Officer, Americas, at International SOS.
  • This roster includes but is not limited to:
    Kelly Johnstone, former Chief Security Officer and Executive Vice President of The Coca Cola Company.

Luis Hernandez, Strategic New Hire, Unique Forensic Technology Products and Services

Retrieved on: 
Thursday, August 11, 2022
Supply chain, Medicine, United States Department of Defense, Assistant, Service-Disabled Veteran-Owned Small Business, CDT, Commerce, Research, Department, CF, Supply chain risk management, PPE, MD, GSA, VR, Program, SDVOSB, Security, ASPR, HUBZone, National Counterproliferation Center, DCIS, MAS, Food and Drug Administration, Crime, Defense Criminal Investigative Service, 2017 BBC Sports Personality of the Year Award, FBI, Office of Criminal Investigations, Virtual reality, OCI, Small business, Counter-proliferation, Contagious disease, Economic development, Solution, FDA, U.S. Department of Commerce Office of Security, First responder, CPC, Intelligence, Special agent, SCRM, Standard operating procedure, Senior Consultant, SOP, Defense, Law enforcement, Private investigator, Industry, Supply

PUNTA GORDA, Fla., Aug. 11, 2022 /PRNewswire-PRWeb/ -- Cambridge Federal, Cambridge Forensics (dba) is pleased to announce the appointment of Mr. Luis Hernandez as the Managing Partner and Director of the Supply Chain Division for Cambridge Forensics. Cambridge Forensics has recently launched it's new forensic tracing and coding line from the SmartWater Group for Supply Chains to it's list of products; Mr. Hernandez will be the resident expert on solutions for all things Supply Chain – welcome to the team!

Key Points: 
  • Cambridge Federal is committed to fostering economic development and career opportunities for the surrounding community.
  • Luis Hernandez has been a Defense Criminal Investigative Service (DCIS) Special Agent, and Program Manager Counterproliferation investigations.
  • Cambridge Forensics is headquartered in Punta Gorda, Florida, and has created a research and development lab investigating unique solutions leveraging the SmartWater Group unique forensic coded products and services for Supply Chain, Law Enforcement, and Medical Contagious Disease Training (CDT) initiatives.
  • Luis Hernandez (Supply Chain Director) LinkedIn: https://www.linkedin.com/in/luis-hernandez-39526963
    Kelli Clark (Office Manager) LinkedIn: linkedin.com/in/kelli-clark-41091697

Former Acting U.S. Attorney Nathaniel Mendell Joins Morrison & Foerster in Boston

Retrieved on: 
Tuesday, March 1, 2022
Financial technology, Color, Civil and political rights, Veteran, The American Lawyer, Government, Intellectual property, Morrison & Foerster, Growth, White House, Morrison, United States Department of Justice, Illegal drug trade, Privacy, IRS Criminal Investigation, Office of Criminal Investigations, District, Lawsuit, Culture, Racketeer Influenced and Corrupt Organizations Act, Environment, Corporation, Harvard Law School, Office of Inspector General, U.S. Department of Health and Human Services, Mofo, Woman, Lawyer, Leadership, Private law, RICO, Federal Bureau of Investigation, Technology, Patent, Justice, State bureau of investigation, Chambers, False Claims Act, Department, Policy, Private investigator, Pharmaceutical industry, Financial services, Property management

BOSTON, March 1, 2022 /PRNewswire-PRWeb/ -- Morrison & Foerster , a leading global law firm, is pleased to announce that Nathaniel Mendell has joined the firm as a partner in its Investigations + White Collar Defense Group , based in the Boston office.

Key Points: 
  • BOSTON, March 1, 2022 /PRNewswire-PRWeb/ -- Morrison & Foerster , a leading global law firm, is pleased to announce that Nathaniel Mendell has joined the firm as a partner in its Investigations + White Collar Defense Group , based in the Boston office.
  • Mr. Mendell joins Morrison & Foerster from the U.S. Attorney's Office for the District of Massachusetts, where he most recently served as Acting U.S. Attorney and previously served as First Assistant U.S. Attorney.
  • Mr. Mendell joins an elite group of former prosecutors who help lead the firm's white collar investigative teams.
  • "Nathaniel is a highly accomplished trial attorney who will be a key asset to our clients in Boston and in the Northeast in particular," said Morrison & Foerster Global Litigation Department Co-Chair Bradley D. Wine .

The Government and FDA Ordered to Return Five Truckloads of DMAA to Hi-Tech Pharmaceuticals

Retrieved on: 
Thursday, June 13, 2019
Health, Warrant, DMAA, Office of Criminal Investigations, Food and Drug Administration, Government

Salinas Judge stated as follows in her ruling on the government taking Hi-Tech's DMAA.

Key Points: 
  • Salinas Judge stated as follows in her ruling on the government taking Hi-Tech's DMAA.
  • The affiant for the DMAA warrants was Gerald Dunham, a special agent with the FDA's Office of Criminal Investigations.
  • The agents then immediately executed the DMAA Warrants and seized massive amounts of Hi Tech's inventory (the "2017 Seized Items").
  • Defendants bring their motion pursuant to Federal Rule of Criminal Procedure 41(g), which provides:
    (g) Motion to Return Property.