Mitigation

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

Retrieved on: 
Tuesday, August 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.

Michael Baker International Introduces vAIRify

Retrieved on: 
Thursday, August 10, 2023
Federal Aviation Administration, Private sector, Software as a service, UAS, Information system, PMP, Aircraft, Mitigation, FAA, Documentation, Engineering, CSM, Anchor Skysuites, National Applications Office, Transport, SOA, GIS, Satellite navigation device, Risk management

PITTSBURGH, Aug. 10, 2023 /PRNewswire/ -- Michael Baker International, a global leader in engineering, planning and consulting services, today introduced vAIRify, a new cloud-native, software-as-a-service (SaaS) offering designed to facilitate safe and effective program management for unmanned aircraft systems (UAS) pilots and program managers. vAIRify is part of Michael Baker's SkySuite, a platform of applications designed to support end-to-end flight planning and program management for the aviation industry.

Key Points: 
  • PITTSBURGH, Aug. 10, 2023 /PRNewswire/ -- Michael Baker International , a global leader in engineering, planning and consulting services, today introduced vAIRify, a new cloud-native, software-as-a-service (SaaS) offering designed to facilitate safe and effective program management for unmanned aircraft systems (UAS) pilots and program managers.
  • vAIRify is part of Michael Baker's SkySuite, a platform of applications designed to support end-to-end flight planning and program management for the aviation industry.
  • "We developed vAIRify to optimize flight planning and reduce the pain points associated with flight documentation – ultimately allowing users to get in the air faster," said Kranti Bandi, CSM, SOA, PMP, National Applications Development Director at Michael Baker International.
  • "vAIRify offers the tools our clients need to develop robust and streamlined UAS programs."

Rightfoot Launches Zero-Login Financial Data for Financial Institutions and Lenders

Retrieved on: 
Thursday, August 10, 2023
Technology, Finance, Security, Fintech, Banking, Professional Services, Software, Data Analytics, Data Management, Kraken, Marketing, Bank statement, NSF, API, BCV, Mitigation, Engineering, Bain Capital Ventures, Black box group, Magic, Growth, Online shopping, Bank, Cryptocurrency

Rightfoot has been building and testing Connect Magic with financial institutions, lenders, and technology companies across the United States, and will use the funds to launch and expand access.

Key Points: 
  • Rightfoot has been building and testing Connect Magic with financial institutions, lenders, and technology companies across the United States, and will use the funds to launch and expand access.
  • Financial institutions need to understand the full financial picture of their customers.
  • Instead of requiring bank username and password, Rightfoot Connect Magic requires only the consent of the customer in order to securely retrieve data.
  • “Getting access to actionable customer data has been a known-mammoth of a problem for financial institutions across sectors and product offerings.

U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma

Retrieved on: 
Thursday, August 10, 2023
Lymphocyte, Safety, Rash, Effectiveness, Janssen Pharmaceuticals, Patient, Fatigue, Disease, Tissue, REMS, University, Neutrophil, Diarrhea, GPRC5D, Xeroderma, Multiple myeloma, Hepatotoxicity, Bone marrow, Toxicity, Research, Ageusia, Independent Review Committee, Cytokine release syndrome, FDA, Headache, Skin, DSM-IV codes, Nail, CD3, CRS, Hypotension, Epithelium, Confidence interval, CR, Weight loss, Johnson & Johnson, Fever, ORR, Dysphagia, Mitigation, Xerostomia, SC, CI, B-cell maturation antigen, Clinical trial, Medicine, Physician, Upper respiratory tract infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, BCMA, Vaccine, Pharmaceutical industry, HORSHAM, Cytopenia, Bispecific monoclonal antibody, Dysgeusia, Infection

HORSHAM, Pa., Aug. 10, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TALVEY™ (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.1 This indication is approved under accelerated approval based on response rate and durability of response.1 Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).1 

Key Points: 
  • * "Patients at this stage of disease have a poor prognosis.
  • Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer."
  • "Our team of scientists never settles in their determination to discover and develop effective therapies.
  • With the discovery of this new antigen, we continue to strive for research breakthroughs while remaining focused on delivering curative regimens in our commitment to eliminate cancer."

CRITICALSTART® Transforms the Security Landscape with Managed Cyber Risk Reduction

Retrieved on: 
Wednesday, August 9, 2023
IDC, NIST, Risk, Mitigation, Magic, Black hat, Information security operations center, Intelligence, Research, Critical Start, SOC, MTTR, Attention, Security information and event management, Security, Organization, Security operations center, MDR, Triage, MCRR, SLA, Benchmarking, MITRE, SIEM, Risk management, Arms industry

PLANO, Texas, Aug. 9, 2023 /PRNewswire/ -- Today, Critical Start, a leading provider of Managed Detection and Response (MDR) cybersecurity solutions, announced the introduction of Managed Cyber Risk Reduction (MCRR), a groundbreaking new approach to security designed to reshape the way businesses combat cyber risks. MCRR, the next evolution of MDR, provides a comprehensive managed solution to address risks, vulnerabilities, and threats. It's designed to go beyond threat-based detect and response to support organizational security programs across the five functions of the National Institute of Standards and Technology Cybersecurity Framework (NIST CSF): Identify, Protect, Detect, Respond, and Recover.

Key Points: 
  • Accessing and analyzing the data required to communicate cyber risk in a way that informs decisions about how security investments and projects translate to risk is often laborious and painful.
  • The Critical Start Cyber Operations Risk & Response™ platform provides holistic cyber risk monitoring, as well as maturity assessments to peer benchmarks, posture analytics, and full response capabilities.
  • "Managed Cyber Risk Reduction extends MDR to include proactive areas of security and delivers the highest level of cyber risk reduction for every dollar invested."
  • "Organizations increase the odds substantially of outwitting cyber-attackers by taking a more proactive and holistic approach to reducing cyber risk, like the one presented by Critical Start's new Managed Cyber Risk Reduction."

VANFLYTA® Now Available in U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Wednesday, August 9, 2023
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Neutropenia, REMS, Maintenance, Hypermagnesemia, Cardiac arrest, Febrile neutropenia, Hypophosphatemia, Magnesium, Diarrhea, Mitigation, Hypocalcemia, Pharmacy, Food, QT interval, Indigestion, ECG, HSCT, Abdominal pain, QT, Sepsis, Acute myeloid leukemia, Alkaline phosphatase, Vomiting, Insomnia, AML, Lymphocytopenia, Patient, NE, Physician, Risk, Hypokalemia, Daiichi Sankyo, Anemia, HR, CR, Mucositis, Nausea, Hypernatremia, FLT3, Fungal infection, Upper respiratory tract infection, Lancet, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Safety, Headache, Thrombocytopenia, Nosebleed, Hyperkalemia, TSE, Disease, Pharmaceutical industry, Hypoalbuminemia

VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.

Key Points: 
  • VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.
  • The results of QuANTUM-First were published in The Lancet .1
    The safety of VANFLYTA was evaluated in 265 patients with newly diagnosed FLT3-ITD positive AML who received VANFLYTA once daily (35.4 mg with chemotherapy, 26.5 to 53 mg as maintenance) in the QuANTUM-First trial.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.
  • Provider and patient support and information regarding distribution, access, and reimbursement are now available through Daiichi Sankyo Access Central by visiting www.DSIAccessCentral.com or calling 1-866-4-DSI-NOW (1-866-437-4669).

UPSHER-SMITH EXPANDS VIGADRONE® (VIGABATRIN) FRANCHISE TO INCLUDE TABLETS

Retrieved on: 
Tuesday, August 1, 2023
Seizure, REMS, Communication, Eye, Risk, Fatigue, Loss, Tremor, Depression, Bronchitis, Use, Medication, Mitigation, Otitis, Health care, Vision, Tablet, Spasm, Magnetic resonance imaging, Eye examination, Medicine, Brain, IME, Parent, Weight gain, Behavior, MRI, Suicidal ideation, Dizziness, Allergy, Patient, Peripheral vision, Swelling, Vigabatrin, CPS, Child, Anemia, Kidney, Somnolence, Irritation, Paratriathlon, FDA, Irritability, Autopsy, Caregiver, Safety, Breast milk, Health insurance, Hydraulic machinery, Retail, Medical device, Nursing, Residential care, Toy, Birth control, Medical imaging, Dietary supplement

MAPLE GROVE, Minn., July 31, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of VIGADRONE® (vigabatrin) Tablets, USP 500 mg, a fully substitutable, AB-rated generic version of Sabril® (vigabatrin) Tablets, 500 mg.* The Company also offers VIGADRONE® (vigabatrin) for Oral Solution, USP 500 mg.

Key Points: 
  • Please see Important Safety Information, including Boxed Warning for Risk of Permanent Vision Loss at the end of this communication.
  • All people who take VIGADRONE:
    You are at risk for permanent vision loss with any amount of VIGADRONE.
  • Your risk of vision loss may be higher the more VIGADRONE you take daily and the longer you take it.
  • The most common side effects of VIGADRONE in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness.

DataDome to Demonstrate How it Stops At-Scale Fraud in its Tracks at Black Hat USA 2023

Retrieved on: 
Tuesday, August 1, 2023
Head, Black hat, API, ChatGPT, ML, PST, Doctor of Philosophy, IPS, Great Places, Mitigation, Medical device, Nightclub, Research

NEW YORK, Aug. 1, 2023 /PRNewswire/ -- DataDome, a leading provider of AI-powered online fraud and bot mitigation, is proud to announce that it is returning to Black Hat USA 2023, both in person and virtually.

Key Points: 
  • NEW YORK, Aug. 1, 2023 /PRNewswire/ -- DataDome , a leading provider of AI-powered online fraud and bot mitigation, is proud to announce that it is returning to Black Hat USA 2023, both in person and virtually.
  • "We are excited to return to Black Hat USA and connect with other cybersecurity professionals keen to learn more about the evolving bot-driven fraud landscape," said Antoine Vastel, Head of Research at DataDome.
  • This year at Black Hat, attendees can:
    Put their site to the test.
  • It is Great Place to Work certified , and was ranked the 21st cybersecurity company on the 2022 Inc. 5000 list.

TruContact Phone Behavior Intelligence and Dialer Intelligence Wins TMC 2023 Contact Center Technology Award

Retrieved on: 
Thursday, July 27, 2023
PBI, TRU, Mitigation, TCPA, TMC, CRM, NYSE, TransUnion, Mobile phone

CHICAGO, July 27, 2023 (GLOBE NEWSWIRE) -- TransUnion (NYSE: TRU) today announced that TMC , a global, integrated media company, has named TruContact™ Phone Behavior Intelligence (PBI) and Dialer Intelligence , powered by Neustar® a 2023 Contact Center Technology Award winner.

Key Points: 
  • CHICAGO, July 27, 2023 (GLOBE NEWSWIRE) -- TransUnion (NYSE: TRU) today announced that TMC , a global, integrated media company, has named TruContact™ Phone Behavior Intelligence (PBI) and Dialer Intelligence , powered by Neustar® a 2023 Contact Center Technology Award winner.
  • “Congratulations to TransUnion for being awarded a 2023 CUSTOMER Magazine Contact Center Technology Award.
  • The TruContact Phone Behavior Intelligence and Dialer Intelligence products have been selected for demonstrating innovation, quality and unique features, which have had a positive impact on the customer experience,” said Rich Tehrani , CEO, TMC.
  • “We’re pleased to recognize their achievement.”
    “We’re honored to receive this award for our solutions,” said Robert McKay, TransUnion senior vice president, TruContact Customer Contact Intelligence Solutions.

Hanwha Aerospace Selected as Preferred Bidder for Land 400 Phase 3 by Australian Army

Retrieved on: 
Thursday, July 27, 2023
Hanwha Group, Land, HDA, Hanwha Aerospace, Army, Redback, AUKUS, COVID, Infantry, Mitigation, South Korea, Commonwealth, Tanks in the Australian Army, Drug

SEOUL, South Korea, July 27, 2023 /PRNewswire/ -- Hanwha Aerospace announced today that its subsidiary, Hanwha Defense Australia(HDA), has been selected as the preferred bidder for the Land 400 Phase 3 Infantry Fighting Vehicle (IFV) program with the Redback IFV.

Key Points: 
  • SEOUL, South Korea, July 27, 2023 /PRNewswire/ -- Hanwha Aerospace announced today that its subsidiary, Hanwha Defense Australia(HDA), has been selected as the preferred bidder for the Land 400 Phase 3 Infantry Fighting Vehicle (IFV) program with the Redback IFV.
  • This program includes 129 vehicles across two variants and will be delivered under an accelerated schedule, in alignment with the Australian Army's Defence Strategic Review.
  • "Hanwha's selection as the preferred bidder for the Land 400 Phase 3 has significant implications for Korea-Australia defense and economic cooperation."
  • "We are excited for the next phase of this program that will see HDA and Australian industry deliver a world class IFV to the Australian Army," said Richard Cho, Managing Director of HDA.