FDC

Genasys Partners in European Union-Funded Project to Revolutionize Public Warning

Retrieved on: 
Tuesday, March 26, 2024

101082555) that goes beyond smartphone-based alerting by developing a solution that will extend the reception and processing of Galileo Emergency Warning Satellite Service (EWSS) public safety warnings into display panels, indoor warning systems, and acoustic devices.

Key Points: 
  • 101082555) that goes beyond smartphone-based alerting by developing a solution that will extend the reception and processing of Galileo Emergency Warning Satellite Service (EWSS) public safety warnings into display panels, indoor warning systems, and acoustic devices.
  • Genasys’ experience in innovating satellite-connected speaker systems that broadcast audible voice messages with exceptional clarity qualified us to partner in this consortium.
  • Genasys Protect ALERT will be used to conduct an end-to-end Project AWARE demonstration with the Republic of Slovenia Administration for Civil Protection and Disaster Relief, a customer and consortium member.
  • The Republic of Slovenia Administration for Civil Protection and Disaster Relief will host one of the demonstrations planned at the end of the project.

VitalEdge Technologies and FDC Solutions Announce Strategic Alliance to support Caterpillar's Dealer Network

Retrieved on: 
Monday, April 8, 2024

As part of this alliance, FDC Solutions becomes the endorsed implementation and support partner for VitalEdge Technologies' end-to-end dealer management platform, e-Emphasys ERP.

Key Points: 
  • As part of this alliance, FDC Solutions becomes the endorsed implementation and support partner for VitalEdge Technologies' end-to-end dealer management platform, e-Emphasys ERP.
  • FDC Solutions provides consulting services and software solutions to more than 80 Cat dealers around the world.
  • "We are excited to partner with VitalEdge Technologies as we strive to provide the next generation of digital transformation solutions to the Cat dealer community," said Bob Jenkins, co-president of FDC Solutions.
  • During the conference, VitalEdge Technologies and FDC Solutions will share additional details on the alliance and their joint development initiatives.

NewAmsterdam Pharma to Present New Analysis from the Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe at 2024 American College of Cardiology Congress

Retrieved on: 
Monday, March 25, 2024

ROSE2 evaluated obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy; full results from the trial were previously presented at the National Lipid Association Scientific Sessions in June 2023.

Key Points: 
  • ROSE2 evaluated obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy; full results from the trial were previously presented at the National Lipid Association Scientific Sessions in June 2023.
  • At ACC, NewAmsterdam will share new data demonstrating obicetrapib and ezetimibe’s impact on small dense LDL-C, a robust predictor of residual risk of future cardiovascular events.
  • NewAmsterdam recently initiated TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC (‘fixed-dose combination”) in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.
  • Details of the presentation are as follows:
    Presentation at the 2024 American College of Cardiology (ACC) Congress:

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD

Retrieved on: 
Tuesday, March 12, 2024

NAARDEN, The Netherlands and MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.

Key Points: 
  • The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk.
  • The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo.
  • NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl.
  • Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet as treatments for hypercholesterolaemia and significantly reducing cardiovascular events

Retrieved on: 
Friday, March 22, 2024

“The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.

Key Points: 
  • “The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.
  • This first-in-class medicine with proven efficacy in reducing hypercholesterolaemia and preventing cardiovascular risks, is a testament to our tireless efforts to help improve the cardiovascular treatment landscape.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024.

ENNOVI Introduces a New Flexible Circuit Production Process for Low Voltage Connectivity in EV Battery Cell Contacting Systems

Retrieved on: 
Wednesday, April 3, 2024

SINGAPORE, April 3, 2024 /PRNewswire/ -- ENNOVI, a mobility electrification solutions partner, introduces a more advanced and sustainable way of producing flexible circuits for low voltage signals in electric vehicle (EV) battery cell contacting systems. While flexible printed circuits (FPC) are often employed in these systems, they are the most expensive component in the current collector assembly. ENNOVI's flexible die-cut circuit (FDC) technology offers a more cost-effective and sustainable solution, with fewer manufacturing procedures and faster continuous reel-to-reel production.

Key Points: 
  • SINGAPORE, April 3, 2024 /PRNewswire/ -- ENNOVI, a mobility electrification solutions partner, introduces a more advanced and sustainable way of producing flexible circuits for low voltage signals in electric vehicle (EV) battery cell contacting systems.
  • While flexible printed circuits (FPC) are often employed in these systems, they are the most expensive component in the current collector assembly.
  • ENNOVI's flexible die-cut circuit (FDC) technology offers a more cost-effective and sustainable solution, with fewer manufacturing procedures and faster continuous reel-to-reel production.
  • Generally, FPCs are manufactured using a multi-stage, batch photolithography process to etch copper traces for the flexible circuit.

ENNOVI Introduces a New Flexible Circuit Production Process for Low Voltage Connectivity in EV Battery Cell Contacting Systems

Retrieved on: 
Wednesday, April 3, 2024

SINGAPORE, April 3, 2024 /PRNewswire/ -- ENNOVI, a mobility electrification solutions partner, introduces a more advanced and sustainable way of producing flexible circuits for low voltage signals in electric vehicle (EV) battery cell contacting systems. While flexible printed circuits (FPC) are often employed in these systems, they are the most expensive component in the current collector assembly. ENNOVI's flexible die-cut circuit (FDC) technology offers a more cost-effective and sustainable solution, with fewer manufacturing procedures and faster continuous reel-to-reel production.

Key Points: 
  • SINGAPORE, April 3, 2024 /PRNewswire/ -- ENNOVI, a mobility electrification solutions partner, introduces a more advanced and sustainable way of producing flexible circuits for low voltage signals in electric vehicle (EV) battery cell contacting systems.
  • While flexible printed circuits (FPC) are often employed in these systems, they are the most expensive component in the current collector assembly.
  • ENNOVI's flexible die-cut circuit (FDC) technology offers a more cost-effective and sustainable solution, with fewer manufacturing procedures and faster continuous reel-to-reel production.
  • Generally, FPCs are manufactured using a multi-stage, batch photolithography process to etch copper traces for the flexible circuit.

NewAmsterdam Pharma Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 28, 2024

NAARDEN, The Netherlands and MIAMI, Feb. 28, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • "2023 was a year of remarkable progress for NewAmsterdam, marked by consistent clinical execution and substantial corporate development.
  • NewAmsterdam completed enrollment of over 350 patients in April 2023 and expects to report topline data in the third quarter of 2024.
  • NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth quarter of 2024.
  • Cash Position: As of December 31, 2023, NewAmsterdam recorded cash of $340.5 million, compared to $467.7 million as of December 31, 2022.

Fosfor Announces the Fosfor Decision Cloud to Amplify Business Outcomes With AI

Retrieved on: 
Monday, March 4, 2024

Fosfor AI radically increases productivity for virtually any user persona, thereby reducing time-to-insights and accelerating the realization of business outcomes.

Key Points: 
  • Fosfor AI radically increases productivity for virtually any user persona, thereby reducing time-to-insights and accelerating the realization of business outcomes.
  • “The Decision Cloud marks a major milestone in the evolution of Fosfor and is a major breakthrough in the way businesses can develop and deploy AI to achieve business value,” said Debasis Satpathy, Chief Business Officer, Fosfor.
  • “Providing the foundational capability to integrate with virtually any data source to cost-effectively bring business data into cloud warehouses where the Decision Cloud can then transform it into insights and business value.
  • We look forward to working together with Fosfor to define the modern decision stack and create transformational outcomes for our customers.”