Intercept

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

Retrieved on: 
Thursday, February 29, 2024

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
  • In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.
  • The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC.
  • Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency.

Raw Story Sues OpenAI for Violating Copyright Act

Retrieved on: 
Wednesday, February 28, 2024

Raw Story, America’s largest independent progressive news site, today filed suit against OpenAI for using thousands of Raw Story’s news articles to train ChatGPT in violation of the Digital Millennium Copyright Act.

Key Points: 
  • Raw Story, America’s largest independent progressive news site, today filed suit against OpenAI for using thousands of Raw Story’s news articles to train ChatGPT in violation of the Digital Millennium Copyright Act.
  • “Raw Story’s copyright-protected journalism is the result of significant efforts of human journalists who report the news,” said Raw Story Publisher Roxanne Cooper.
  • Begun as a small, one-man political blog, Raw Story grew to become the largest independent progressive news website in America.
  • The suit is case 24-cv-01514, Raw Story Media, Inc. et al v. OpenAI, Inc. et al.

Boost Payment Solutions Shares Business Momentum Highlighted by Over $12 Billion Processed and a 195% Year-Over-Year Increase in Transactions in 2023

Retrieved on: 
Monday, January 29, 2024

NEW YORK, Jan. 29, 2024 /PRNewswire/ -- Boost Payment Solutions, a global leader in B2B payments, today shared some of the company's key business highlights from 2023, including having processed a company-record single largest commercial card payment in 2023 in the amount of $50 million. By optimizing B2B payment processes, Boost is helping businesses streamline their operations, optimize working capital, reduce costs, and improve efficiency.

Key Points: 
  • By optimizing B2B payment processes, Boost is helping businesses streamline their operations, optimize working capital, reduce costs, and improve efficiency.
  • "Throughout 2023, Boost has experienced significant growth and success, solidifying our position as a leader in the industry," said Dean M. Leavitt, Founder and CEO of Boost Payment Solutions.
  • Our innovative and patented B2B payment solutions have gained widespread recognition with over 50 percent of the 2023 Fortune 100 companies having made or received payments through the Boost platform."
  • Boost Intercept, patented in the U.S. and Canada, is a straight-through processing (STP) payment technology that eliminates the need for human intervention in payment and reconciliation.

Sophos Positioned a Leader in the 2023 Gartner® Magic Quadrant™ for Endpoint Protection Platforms for the 14th Consecutive Time

Retrieved on: 
Friday, January 12, 2024

OXFORD, United Kingdom, Jan. 12, 2024 (GLOBE NEWSWIRE) -- Sophos , a global leader in innovating and delivering cybersecurity as a service, today announced that it is positioned as a Leader in the 2023 Gartner® Magic Quadrant™ for Endpoint Protection Platforms (EPP), marking the 14th consecutive time the company has been a Leader in the report.

Key Points: 
  • OXFORD, United Kingdom, Jan. 12, 2024 (GLOBE NEWSWIRE) -- Sophos , a global leader in innovating and delivering cybersecurity as a service, today announced that it is positioned as a Leader in the 2023 Gartner® Magic Quadrant™ for Endpoint Protection Platforms (EPP), marking the 14th consecutive time the company has been a Leader in the report.
  • Already this year, Sophos was named a Customers’ Choice in the Gartner® Peer Insights™ Voice of the Customer for Endpoint Protection Platforms (EPP) report.
  • Like Intercept X, Sophos MDR is recognized and is the most reviewed MDR solution on Gartner Peer Insights and G2 .
  • Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact.

DTEX Systems Collaborates with Google Public Sector, Carahsoft and Coalfire to Supercharge Insider Risk Defenses in US Government

Retrieved on: 
Tuesday, January 9, 2024

DTEX Systems , the global leader for insider risk management, today announced it is collaborating with Google Public Sector, Carahsoft Technology Corp. and Coalfire to expedite its FedRAMP accreditation.

Key Points: 
  • DTEX Systems , the global leader for insider risk management, today announced it is collaborating with Google Public Sector, Carahsoft Technology Corp. and Coalfire to expedite its FedRAMP accreditation.
  • The collaboration will enable DTEX to expand its Federal footprint while accelerating adoption and time-to-value of its purpose-built InTERCEPT platform for Federal insider risk management.
  • “Recent cases of data loss, including the leaks of classified Pentagon documents, highlight the need for risk adaptive technologies to proactively prevent insider-related security incidents,” said Marshall Heilman, DTEX Systems CEO.
  • “Google Public Sector is committed to working with partners such as DTEX Systems to fast-track compliance and bring innovative data-driven technologies, including AI, and expertise to government agencies faster,” said Troy Bertram, managing director of Google Cloud’s Public Sector Partner Ecosystem.

“Sophos MDR is a Must” and Sophos Intercept X is “A Real Threat for Hackers,” Say Sophos Customers in G2’s Peer-to-Peer Winter 2024 Report

Retrieved on: 
Monday, December 18, 2023

OXFORD, United Kingdom, Dec. 18, 2023 (GLOBE NEWSWIRE) -- “Sophos MDR is a must.” Sophos Intercept X is “…a real threat for hackers!” This is a sampling of the praise Sophos customers shared in G2’s peer-to-peer Winter 2024 Report, making Sophos the only vendor to earn the coveted Leader position in five key cybersecurity categories. This is the fourth report in a row where Sophos has swept as a Leader. The five categories include:

Key Points: 
  • “It’s a true honor when our customers confirm that, ‘Sophos MDR is a must,’ and our Sophos Intercept X endpoint solution is ‘a real threat for hackers,’” said Raja Patel, chief product officer at Sophos.
  • “This confidence is the reason Sophos repeatedly sweeps the cybersecurity categories in G2’s customer ratings reports.
  • This proactive and hands-on approach is what sets Sophos MDR apart and makes it a highly appreciated solution,” said a mid-market customer
    “…a real threat for hackers !!!
  • They’re powered by Sophos X-Ops threat intelligence, a cross-operational task force of more than 500 security experts within SophosLabs, Sophos SecOps and SophosAI.

Terns Pharmaceuticals Mourns the Loss of Senthil Sundaram, Former Chief Executive Officer

Retrieved on: 
Monday, November 27, 2023

Sen was a visionary leader who inspired us all with his passion, dedication, and unwavering commitment to improving patient care through scientific innovation.

Key Points: 
  • Sen was a visionary leader who inspired us all with his passion, dedication, and unwavering commitment to improving patient care through scientific innovation.
  • Our thoughts and prayers are with his family and loved ones during this difficult time,” said David Fellows, Chairman of the Board of Terns.
  • Prior to joining Terns in August 2020, Mr. Sundaram was the Chief Financial Officer of Nightstar Therapeutics plc, a clinical-stage gene therapy company, until it was acquired by Biogen in 2019.
  • Prior to Nightstar, Mr. Sundaram served in a variety of positions at Intercept Pharmaceuticals, Inc., including most recently as its Vice President and Head of Business Development.

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023

These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).

Key Points: 
  • These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).
  • One severe TEAE (pruritus, OCA5/B100 IR) occurred in Study 214; no TEAEs led to study discontinuation in Study 214.
  • The Company expects to have the necessary data from the OCA-bezafibrate combination program to submit a request in 2023 for an End-of-Phase 2 meeting with the FDA.
  • These data include analyses from both Phase 2 studies, in addition to Phase 1 and preclinical data.

SHI Joins DTEX Global Partner Program to Meet Increasing Worldwide Demand for Proactive Insider Risk Management Solutions

Retrieved on: 
Thursday, December 14, 2023

DTEX Systems, the global leader in insider risk management, today announced the addition of SHI International Corp. to the DTEX Systems Global Partner Program .

Key Points: 
  • DTEX Systems, the global leader in insider risk management, today announced the addition of SHI International Corp. to the DTEX Systems Global Partner Program .
  • As the newest member of the DTEX partner network, SHI will help customers enhance their insider risk management capabilities and mitigate data loss.
  • SHI helps companies achieve business goals through the use of technologies, including cybersecurity solutions that address people, technology, and processes.
  • “Insider risk continues to be the fastest growing area of cybersecurity today,” said Brian Stoner, Vice President, Worldwide Channel and Alliances, DTEX Systems.

Abcuro Appoints Mark Pruzanski, M.D., as Chairman of its Board of Directors

Retrieved on: 
Wednesday, December 6, 2023

Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced the appointment of Mark Pruzanski, M.D., as Chairman of its Board of Directors.

Key Points: 
  • Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced the appointment of Mark Pruzanski, M.D., as Chairman of its Board of Directors.
  • Dr. Pruzanski brings more than 30 years of experience as a life sciences executive, entrepreneur and investor.
  • “We are thrilled to welcome Mark as the Chairman of the Board during a pivotal stage for Abcuro as we continue to advance our registrational Phase 2/3 MUSCLE clinical study for the treatment of inclusion body myositis,” said Alex Martin, Chief Executive Officer of Abcuro.
  • “Mark is a biotech leader with a proven record in bringing innovative new medicines to market for patient populations with unmet medical needs.