EC

European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Systemic Sclerosis

Retrieved on: 
Thursday, June 22, 2023
Inflammation, Civil service commission, Prevalence, Small RNA, Marketing, ATyr Pharma, European Medicines Agency, COMP, Neuropilin, Scar, ILD, Toxicity, Medicine, Sarcoidosis, Research, FC, Scleroderma, Biomarker, Committee, EMA, Fibrosis, Patient, SAN, Autoimmune disease, European, Biology, Diagnosis, FDA, EC, Death, Systemic scleroderma, Skin, European Commission, Safety, Disease, Pharmaceutical industry, EU

Efzofitimod is a first-in-class immunomodulator that downregulates innate immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2.

Key Points: 
  • Efzofitimod is a first-in-class immunomodulator that downregulates innate immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2.
  • “We are pleased that the EC recognizes the need for new and impactful treatments for the nearly 100,000 people living with systemic sclerosis in the European Union (EU),” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr.
  • “This orphan drug designation takes into account more than just the rarity of the disease.
  • Efzofitimod received orphan drug and Fast Track designations for systemic sclerosis from the United States Food and Drug Administration (FDA) in 2022.

Interlink Electronics, Inc. Announces Expansion of its Electrochemical Gas Sensors Family with Solutions for Hydrogen, Ammonia and NOX Gases at Sensors Converge Conference in Santa Clara, CA on June 21 and 22

Retrieved on: 
Wednesday, June 21, 2023
Internet of things, Interlink, Gas, Booth, Electronics, HMI, NOX, Interlink Electronics, Consumer, EC, Conference, Instrumentation, Hydrogen, Health care, Automotive industry, Ammonia, Industrial

IRVINE, Calif., June 21, 2023 /PRNewswire/ -- Interlink Electronics, Inc. (NASDAQ: LINK), a world-leading trusted technology partner in the rapidly advancing world of human-machine interface (HMI) devices, sensors, membrane keypads and other cutting-edge technologies, is pleased to announce the launch of its new miniature electrochemical gas sensors for accurate detection of Hydrogen, Ammonia and NOX gases.

Key Points: 
  • These sensors will be on display at Booth 1050 at the Sensors Converge Conference in Santa Clara, CA on June 21st & 22nd.
  • This prestigious event brings together industry leaders, innovators, and experts from the sensor technology domain, offering a unique platform for networking, knowledge sharing, and exploring the latest advancements in this dynamic field.
  • "These additions to our product portfolio increase the breadth of gas sensing options we can provide to our customers while also enabling us to offer unique, fully integrated, application-specific complete solutions," said Steven N. Bronson, President and CEO.
  • The company's technical team will be available to discuss customers' specific requirements and help develop solutions that will address their most challenging sensing needs.

CSL Behring Announces the First Patient Has Received FDA-Approved HEMGENIX® (etranacogene dezaparvovec-drlb) for Hemophilia B

Retrieved on: 
Tuesday, June 20, 2023
Insurance, Medicine, Bleeding, Senior, Civil service commission, Life, CSL Behring, Health care, Medicines and Healthcare products Regulatory Agency, Food and Drug Administration, Factor IX, Haemophilia, IX, Data collection, Medication, CSL, Organization, MD, Standard of care, Patient, European Economic Area, European, Joint, United Kingdom, FDA, EC, Food, European Commission, Safety, Medical device, Pharmaceutical industry, Nursing, Health insurance

"As part of our longtime promise to patients, CSL Behring is thrilled to mark this latest milestone of the first commercial patient having received HEMGENIX and look forward to continuing to deliver this paradigm-shifting treatment to the hemophilia B community," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring.

Key Points: 
  • "As part of our longtime promise to patients, CSL Behring is thrilled to mark this latest milestone of the first commercial patient having received HEMGENIX and look forward to continuing to deliver this paradigm-shifting treatment to the hemophilia B community," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring.
  • While prophylactic hemophilia B treatments have significantly advanced over the past several decades and are effective, treatments are typically administered on a strict infusion schedule and breakthrough bleeds into joints are still possible.
  • HEMGENIX has the potential to fundamentally transform the treatment paradigm through a single, one-time infusion in people living with hemophilia B by addressing the genetic cause of the condition.
  • "As of May 2023, payers covering roughly 60 percent of the U.S. population have established clear medical policies covering HEMGENIX.

MRCT Center and Medable Launch First, Comprehensive IRB/EC Review Toolkit for Decentralized Clinical Trials

Retrieved on: 
Tuesday, June 20, 2023
Data Management, Biotechnology, Technology, FDA, Health, Pharmaceutical, Medical Devices, Research, Software, Science, Clinical Trials, Faculty, Tufts Center for the Study of Drug Development, Public, ECS, Clinical trial, Data collection, Innovation, EST, Multimedia, Committee, DCT, DCTS, Harvard University, Bangladesh Technical Education Board, Ethics, Trial of the century, Harvard Medical School, Certified IRB Professional, Patient, IRB, OHRP, Office for Human Research Protections, Annual general meeting, Drug development, Hospital, Institutional review board, DIA, EC, Food, Medical device, Medicine

Medable Inc. , the leading technology provider for patient-centric clinical trials, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) announce a comprehensive toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review.

Key Points: 
  • Medable Inc. , the leading technology provider for patient-centric clinical trials, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) announce a comprehensive toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review.
  • The first-of-its-kind toolkit provides a common framework, tools, and best practices for uniform ethical review and approval and provides a roadmap for the ethical conduct of DCTs.
  • View the full release here: https://www.businesswire.com/news/home/20230620838809/en/
    MRCT Center and Medable Launch Comprehensive IRB/EC Review Toolkit for DCTs (Graphic: Business Wire)
    “The new DCT IRB/EC Review Toolkit will ease ethics reviews of decentralized trials by establishing commonality and removing some of the guesswork that has made DCT reviews cumbersome,” said Dr. Barbara Bierer , Professor of Medicine at Harvard Medical School and Faculty Director of the MRCT Center.
  • Medable’s customers have achieved impressive results with decentralized and hybrid trials – including 200 percent faster enrollment and 50 percent cost reductions.

Santhera Grants Exclusive North America License for Vamorolone to Catalyst Pharmaceuticals in Deal Valued at up to USD 231 Million Plus Royalties

Retrieved on: 
Tuesday, June 20, 2023
Centerview Partners, Treasury, Vamorolone, Catalyst Pharmaceuticals, Prescription Drug User Fee Act, JSC, Duchenne muscular dystrophy, Civil service commission, Marketing, Health care, European Medicines Agency, LR, NDA, European Directive on Traditional Herbal Medicinal Products, Medication, USD, Committee, EMA, U.S. FDA, Standstill, Patient, CEST, PDUFA, Committee for Medicinal Products for Human Use, MAA, Rare, FDA, EC, News, Muscular dystrophy, European Commission, MHRA, CHMP, BST, Tutoring, Pharmaceutical industry, Dentistry, EU, DMD, Catalysis

Total consideration to Santhera is up to USD 231 million (including equity investment), plus royalty payments from product sales, with near-term cash proceeds for Santhera of USD 126 million.

Key Points: 
  • Total consideration to Santhera is up to USD 231 million (including equity investment), plus royalty payments from product sales, with near-term cash proceeds for Santhera of USD 126 million.
  • Under the terms of the agreement, Santhera will grant Catalyst exclusive commercialization rights to vamorolone in North America, comprising the U.S., Canada and Mexico.
  • At closing, Santhera will receive an upfront cash payment of USD 75 million.
  • Santhera will host a conference call on June 20, 2023, at 14:30 CEST / 13:30 BST / 08:30 EDT to discuss the agreement on vamorolone.

ACI Readies European Banks and Merchants for Instant Payments

Retrieved on: 
Tuesday, June 20, 2023
Mobile, Wireless, Technology, Payments, Finance, Security, Fintech, Banking, Professional Services, Software, Artificial Intelligence, Transfer, Acceleration, SEPA, API, EPC, ACI Worldwide, ACIW, Mandate, RT1, Warsop, Friction, Credit transfer, TIPS, SCT, Growth, EC, ACI, European Commission, Single Euro Payments Area, Cryptocurrency, Bank, Mobile phone, Electronic funds transfer, EU

In addition, ACI recently launched its ACI Instant Pay solution in Europe and the U.K., enabling merchants to accept online, mobile and in-store payments instantly via a simple API integration with ACI Payments Orchestration Platform.

Key Points: 
  • In addition, ACI recently launched its ACI Instant Pay solution in Europe and the U.K., enabling merchants to accept online, mobile and in-store payments instantly via a simple API integration with ACI Payments Orchestration Platform.
  • Merchants are set to gain significantly from the adoption of instant payments through the elimination of interchange fees, instant settlement — which means instant liquidity — and the elimination of chargebacks.
  • “Instant payments will help to secure the competitiveness of banks, financial services providers and merchants.
  • In 2022, instant payments were 2.5% of total payments volume, while other forms of electronic payments represented 66.4%, and paper-based payments represented 31.1%.

Elite Robots is coming back strong to Automatica with new top-of-the-line cobots and strategic partners

Retrieved on: 
Tuesday, June 20, 2023
Software, Technology, Robotics, Electronic Design Automation, ISO, TCP, 3D, CS, Multimedia, Hygiene, International Federation of Automatic Control, Photography, IP68, FPS, AIR, Quality control, EC, Welding, Automation, Mobile phone, Nightclub, Computer data storage, Telescopic sight

(Photo: Business Wire)

Key Points: 
  • (Photo: Business Wire)
    Elite Robots will present a range of cutting-edge end-to-end solutions, developed in collaboration with its local partners, at HALL B4 - Booth 311.
  • The spotlight will undoubtedly be on the new top-of-the-line products launched by Elite Robots in 2023: EC64-19 and CS620.
  • Making its European debut at Automatica, the CS620 is poised to impress the public.
  • CS620 will soon be joined by Elite Robots’ new heavyweight champion, CS625.

EBA issues Opinion in response to the European Commission’s proposed amendments to the draft technical standards on crowdfunding service providers

Retrieved on: 
Sunday, June 18, 2023
Prejudice, European Banking Authority, Civil service commission, European Data Protection Supervisor, Commission, Opinion, General Data Protection Regulation, Risk management, EBA, Intention, Documentation, European, Time, Authority, EC, European Commission, RTS, Medical device, EU

14 June 2023

Key Points: 
  • 14 June 2023
    The European Banking Authority (EBA) published today an Opinion on the amendments proposed by the European Commission to the EBA final draft Regulatory Technical Standards (RTS) on requirements on credit scoring of crowdfunding projects, pricing of crowdfunding offers, and risk management policies and procedures.
  • In the Opinion, while accepting the change proposed by the Commission on the treatment of personal data, the EBA notes the importance of ensuring that crowdfunding providers can access historical data to improve the assessment of creditworthiness and the performance of their scoring models.
  • In its Opinion, the EBA recognises the importance of treating personal data in accordance with the “storage limitation” principle established under Article 5(1) of the General Data Protection Regulation (EU) 2016/679 (‘GDPR’) and, therefore, accepts the proposed amendment.
  • This Opinion is based on Article 10(1) of Regulation (EU) No 1093/2010 (‘EBA Regulation’), which requires the Authority to submit its response in the form of an opinion to amendments proposed by the European Commission.

Ecopetrol informs resignation of Vice-President of Corporate Affairs and General Secretary

Retrieved on: 
Saturday, June 17, 2023
Permian, Corporate Affairs, Telecommunications, Multimedia, XM, Acquisition, Gulf of Mexico, ISA, BVC, Growth, Transport, EC, NYSE, Behavior

BOGOTÁ, Colombia, June 16, 2023 /PRNewswire/ -- Ecopetrol S.A. (BVC: ECOPETROL; NYSE: EC) informs that the Vice President of Corporate Affairs and General Secretary, María Paula Camacho Rozo, resigned from her position effective July 5, 2023, to assume a new professional challenge in another company.

Key Points: 
  • BOGOTÁ, Colombia, June 16, 2023 /PRNewswire/ -- Ecopetrol S.A. (BVC: ECOPETROL; NYSE: EC) informs that the Vice President of Corporate Affairs and General Secretary, María Paula Camacho Rozo, resigned from her position effective July 5, 2023, to assume a new professional challenge in another company.
  • The company appreciates the management and achievements of Maria Paula during her 25 years of work for the Ecopetrol Group and wishes her success in her new professional projects.
  • Ecopetrol is the largest company in Colombia and one of the main integrated energy companies in the American continent, with more than 18,000 employees.
  • This press release contains business prospect statements, operating and financial result estimates, and statements related to Ecopetrol's growth prospects.

Tachyum Among Recipients of 8.1 Billion Euro IPCEI Grant

Retrieved on: 
Tuesday, June 13, 2023
Technology, Hardware, Semiconductor, Civil service commission, GPGPU, Research, Information, TPU, CAPEX, CPU, European Commission, HPC, Prodigy, OPEX, AI, Union, EC, Economics, GPU, Renewable energy, Video game, EU

Tachyum ™ is one of 56 companies from 14 European Union countries selected to share in an up to 8.1 billion euro public grant as part of a recently announced Important Project of Common European Interest in Microelectronics and Communication Technologies (IPCEI ME/CT).

Key Points: 
  • Tachyum ™ is one of 56 companies from 14 European Union countries selected to share in an up to 8.1 billion euro public grant as part of a recently announced Important Project of Common European Interest in Microelectronics and Communication Technologies (IPCEI ME/CT).
  • The IPCEI is part of a wider EC effort to ensure a greener, digital, more secure, resilient and sovereign European economy.
  • Tachyum is participating in IPCEI with the project “Accelerating Prodigy 2 HPC/AI, an EU processor,” which addresses a fundamental tenet of the multi-national program – the need for a competitive EU processor.
  • In addition to the 8.1 billion euros in public funding, an additional 13.7 billion euros is expected in private investments.