IL-MINDBREEZE
16.1.2020 14:02:12 CET | Business Wire | Press release
Mindbreeze, a leading provider of appliances and cloud services for knowledge management, and Booz Allen Hamilton, a leader in management and technology consulting, are collaborating with the Food and Drug Administration (FDA) to deliver enterprise search capabilities for the Center for Drug Evaluation and Research (CDER) regulatory review community. The intelligent Mindbreeze InSpire solution was successfully launched in October to provide broad search capabilities for critical review information and a decision-support mechanism to aid the review process for the Center’s regulated products.
“We are proud to partner with Mindbreeze and the FDA to deliver leading-edge search capabilities to support the Agency’s important public health mission,” said Dr. Roman Salasznyk, Vice President at Booz Allen. “Our team of technologists and enterprise search experts are committed to transform FDA’s human drug review process leveraging enabling technologies that ultimately help bring live-saving treatments to market with greater speed and efficiency.”
Mindbreeze InSpire supports the FDA staff in efficiently managing the drug review process with a solution that compiles more than 150 million submission documents, reviews, and communications into a single user interface and makes them available as a consolidated knowledge base. The solution combines the latest technological developments such as machine learning, natural language processing, and AI-supported search functions in an appliance that is easy to use and implement.
“Our partner Booz Allen Hamilton has built up a wealth of expertise about Mindbreeze in recent years. Their implementation skills and commitment make them the perfect partner for us and our efforts to accelerate future large-scale projects across the US government and life sciences sectors,” adds Daniel Fallmann, founder and CEO of Mindbreeze.
About Mindbreeze
Mindbreeze is a leading international provider of appliances and cloud services for enterprise search, applied artificial intelligence, and knowledge management. Mindbreeze’s global network of partners makes it possible to serve customers across time zones anywhere in the world.
You can find more information at www.mindbreeze.com or follow us on LinkedIn and Twitter @Mindbreeze.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200116005419/en/
Link:
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Phase 3 RAINIER Results Supporting Best-in-Class Potential of Povetacicept in IgA Nephropathy Published in the New England Journal of Medicine and Presented at the American Society of Nephrology Kidney Week 202623.10.2026 19:42:00 CEST | Press release
- Vertex is on track for the U.S. FDA Prescription Drug User Fee Act (PDUFA) date of November 30 for potential accelerated approval of povetacicept –- Data published in NEJM and presented at ASN highlight povetacicept’s unique trifecta of efficacy, favorable safety, and the simplicity of dosing at-home every 4 weeks with a low-volume autoinjector –- Data presented at ASN include a qualitative study examining patient perspectives on current and emerging IgAN therapies, showing that 96% of participants preferred an autoinjector over a prefilled syringe, and 80% of participants preferred dosing every 4 weeks versus weekly dosing - - New clinical studies of povetacicept underway including a study evaluating patient experience on povetacicept administered via autoinjector - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the publication of Phase 3 RAINIER results for povetacicept in the New England Journal of Medicine (NEJM), presentation of these data at the American Soc
BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer23.10.2026 16:15:00 CEST | Press release
New data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 monthsTEVIMBRA-containing arm was associated with a four-month longer median OS compared with ZIIHERA plus chemotherapy BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new survival results from the planned second interim analysis (IA2) and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA® (tislelizumab) plus ZIIHERA® (zanidatamab) and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (LBA79). Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne,
Lifezone Metals Confirms Advanced Negotiations with Orion CMC on Kabanga Nickel Project23.10.2026 16:10:00 CEST | Press release
Lifezone Metals Limited (NYSE: LZM) notes comments made today by Oskar Lewnowski, Founder and Group Chief Executive of Orion Resource Partners, in an interview with Bloomberg Television regarding the Company’s Kabanga Nickel Project in Tanzania. In response to inbound inquiries from media outlets and investors following the interview, the Company can confirm that negotiations with Orion Critical Mineral Consortium (Orion CMC) regarding a significant equity investment into the Kabanga Nickel Project are at an advanced stage. The Orion CMC is a global investment platform launched by Orion Resource Partners in partnership with the U.S. International Development Finance Corporation (DFC) and Abu Dhabi's sovereign investor ADQ. As previously announced, the Company has been running a competitive process, led by Standard Chartered Bank, to secure a strategic investment into the Kabanga Nickel Project. Social Media LinkedIn | X | YouTube About Lifezone Metals Lifezone Metals (NYSE: LZM) is com
inDrive and Pony.ai Announce Collaboration to Explore Autonomous Mobility in Kazakhstan Built on NVIDIA Hyperion23.10.2026 15:00:00 CEST | Press release
Collaboration will establish the roadmap for bringing Pony.ai robotaxis to Kazakhstan on the inDrive ride-hailing platform, leveraging the NVIDIA Hyperion and the NVIDIA Halos safety system. inDrive, the global mobility and delivery platform, today announced it has signed a memorandum of understanding (MOU) with NVIDIA and Pony.ai, a global leader in the large-scale commercialization of autonomous driving technology, to explore the future of autonomous ride-hailing. Kazakhstan will serve as the first test market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261023143469/en/ inDrive partners with Pony.ai and NVIDIA to explore autonomous mobility in Kazakhstan Kazakhstan was chosen first for its regulatory readiness following the creation of the country’s first structured legal framework for driverless transport, as part of its “Year of Digitalization and Artificial Intelligence.” Combined with Kazakhstan’s position as a lea
Brenus Pharma's Novel In Vivo Immunotherapy STC-1010 Shows Safety, Activating T Cells in First-Line MSS Metastatic Colorectal Cancers With 2 Complete Responses.23.10.2026 14:50:00 CEST | Press release
Phase Ia BreAK CRC-001 at ESMO 2026: 43% of patients, all initially unresectable, became eligible for surgery Poster 1023P – Developmental Therapeutics Brenus Pharma, a clinical-stage biotech company, announced first data from the Phase Ia dose escalation of BreAK CRC-001. Nine unresectable patients were treated; 89% had liver metastases and 89% KRAS-mutant tumors, a population refractory to immunotherapy. Median follow-up: 8 months (1–14; data cut-off 6/08/2026). 95% of metastatic colorectal cancers are pMMR/MSS tumors, poorly immunogenic and resistant to immunotherapy. STC-1010, the company’s lead in vivo DC-engager, is designed to make these “cold” tumors visible to immune cells. Safety: no dose-limiting toxicity, only grade 1–2 related adverse events. Clinical activity (seven evaluable patients, RECIST 1.1): 100% disease control, 57% objective response rate (4/7). 43% of patients became operable (3/7): two with no evidence of disease afterward. Molecular profile: ctDNA dropped by u
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
