CFR

IceCure Medical Files Appeal with U.S. FDA Requesting a Review of its De Novo Classification for ProSense® in Early-Stage Breast Cancer

Retrieved on: 
Wednesday, November 15, 2023

IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients.

Key Points: 
  • IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients.
  • On September 20, 2023, IceCure announced that the FDA denied its De Novo request.
  • Per the FDA's guidelines, IceCure expects a response to its appeal by the end of January 2024.
  • Outside of the U.S., ProSense® is approved for early-stage breast cancer in numerous countries, including in the European Union, Brazil, and China.

GA Telesis Engine Services' U.S. SPAH Facility Receives FAA Part 145 Air Agency Certificate

Retrieved on: 
Tuesday, November 14, 2023

With this major milestone, the joint venture will provide the airline industry with quick-turnaround jet engine maintenance and play an instrumental role in increasing performance reliability.

Key Points: 
  • With this major milestone, the joint venture will provide the airline industry with quick-turnaround jet engine maintenance and play an instrumental role in increasing performance reliability.
  • "We are ready to serve our customers' needs," said Russ Shelton, president of GA Telesis Engine Strategies .
  • "The Wilmington Air Park is within 1,500 trucking miles of 80 percent of the engine maintenance opportunities in North America, and we have prepared over the last year to hit the ground running.
  • This is a major milestone in the evolution of our partnership with ATSG ."

UMF|PerfectCLEAN Introduces QUICKfoam™>10, a Groundbreaking Solution for Eliminating Biofilm in Drains

Retrieved on: 
Monday, November 13, 2023

NORTHBROOK, Ill., Nov. 13, 2023 /PRNewswire/ -- UMF|PerfectCLEAN is pleased to introduce QUICKfoam™>10, a game-changing product developed to transform the fight against biofilm in drains. QUICKfoam>10 is a 10-gallon, battery-powered foaming unit that generates high-density Klorese™ disinfectant foam to treat any size drain. Klorese is the only chemistry with a neutral pH that is EPA-registered to kill bacteria in biofilm and meets the legal requirements of EPA regulation 40 CFR 403 for sanitary sewer disposal, meaning it is safe to pour down the drain. Biofilm is a protective slime that makes pathogens highly resistant to disinfectants. QUICKfoam>10 foams away bacteria in biofilm safely, efficiently, and thoroughly.

Key Points: 
  • "These pathogens form wet biofilm in drains and p-traps, allowing them to persist for long periods of time.
  • With QUICKfoam>10 , our healthcare customers have an invaluable tool in mitigating the risk to patients from antibiotic-resistant organisms in biofilm.
  • The guidelines included a recommendation to disinfect sink drains using an EPA-registered disinfectant with kill claims against bacteria in biofilm.
  • EPA-Registered and Neutral pH: Klorese, the core component of QUICKfoam-10, is EPA-registered to kill biofilm while maintaining a neutral pH.

S&P Global Commodity Insights' Fertecon Ammonia Benchmarks Selected As Basis For ICE Futures Contract

Retrieved on: 
Thursday, November 9, 2023

NEW YORK, Nov. 9, 2023 /PRNewswire/ -- The Platts Fertecon spot physical price assessment of ammonia delivered to Northwest Europe on a cost and freight basis (CFR NWE Ammonia) was selected by Intercontinental Exchange, Inc. (NYSE:ICE), a leading global provider of data, technology, and market infrastructure, as the basis for a new ammonia futures contract. Platts and Fertecon are part of S&P Global Commodity Insights, the leading independent provider of information, analysis, data and benchmark prices for commodities, energy and energy transition markets.

Key Points: 
  • Platts and Fertecon are part of S&P Global Commodity Insights, the leading independent provider of information, analysis, data and benchmark prices for commodities, energy and energy transition markets.
  • The new ICE ammonia futures contract will financially settle against the Platts Fertecon weekly price of anhydrous ammonia (of 82% nitrogen and transported as a liquid under pressure at approximately -33°Celcius) as delivered duty-paid or duty-free on a cost and freight basis to Northwest Europe.
  • Fertecon is well known for half a century for its benchmark status in fertilizer-based price assessments such as ammonia.
  • In addition to the futures contract based on the Platts Fertecon Ammonia price assessments, ICE will also be launching spread derivatives that are based on three Platts spot physical price differentials assessments for Fuel Oil and Oil:
    The Platts and Platts Fertecon price assessments, licensed by ICE, appear in S&P Global Commodity Insights publications and services, including Ammonia Market Report.

Markforged Introduces FX10, The Most Versatile Tool Designed For The Factory Floor

Retrieved on: 
Tuesday, November 7, 2023

Continuing Markforged’s heritage of reliable printers that deliver strong, precise parts, the FX10 is designed to supercharge manufacturing line productivity and profitability.

Key Points: 
  • Continuing Markforged’s heritage of reliable printers that deliver strong, precise parts, the FX10 is designed to supercharge manufacturing line productivity and profitability.
  • View the full release here: https://www.businesswire.com/news/home/20231107499924/en/
    The FX10 features built-in automation for quality assurance and print routines designed to deliver strong, accurate parts every print.
  • (Photo: Business Wire)
    “We engineered the FX10 to be the best tool for the manufacturing floor,” said Shai Terem, CEO of Markforged.
  • The FX10 can accelerate the digitization of the manufacturing floor by increasing the adoption of digital inventory to build supply chain resiliency.

DP World Expands Automotive Logistics Expertise with Acquisition of CFR Rinkens

Retrieved on: 
Thursday, October 19, 2023

DP World , a global leader in supply chain solutions has reinforced its commitment to the global automotive industry with the acquisition of CFR Rinkens , a specialized logistics service provider headquartered in Long Beach, California.

Key Points: 
  • DP World , a global leader in supply chain solutions has reinforced its commitment to the global automotive industry with the acquisition of CFR Rinkens , a specialized logistics service provider headquartered in Long Beach, California.
  • The acquisition of CFR Rinkens represents a strategic move to enhance its capabilities in delivering precisely tailored solutions to its automotive clients.
  • CFR Rinkens, with its specialized expertise, provides invaluable proficiency in containerized finished vehicles, semi-knock-down vehicle logistics, and innovative racking systems.
  • Beat Simon, Global Chief Commercial Officer, Logistics at DP World, said: “We are thrilled to welcome CFR Rinkens into the DP World family as we continue to deliver our strategy to provide innovative end-to-end logistics services to our clients.

Cadmus Awarded Multi-year, USAID ES3 Contract With $93 Million Total Ceiling

Retrieved on: 
Thursday, October 12, 2023

Winning ES3 highlights Cadmus’ ongoing role as the Agency’s leading safeguards support contractor.

Key Points: 
  • Winning ES3 highlights Cadmus’ ongoing role as the Agency’s leading safeguards support contractor.
  • This single-award, Agency-wide contract supports a consistent, quality approach to safeguards implementation across USAID, including implementing partner training and environmental officer backstopping support.
  • Cadmus will deliver via its dedicated in-house USAID safeguards support team, its in-house and global network of subject matter experts, and by bringing to USAID the full capabilities of its small business-centered ES3 team.
  • “We are incredibly proud that the Cadmus team has been awarded this contract to continue our environmental and social safeguards support for USAID,” said President and CEO Ian Kline.

Cullen/Frost Bankers, Inc. Hosts Third Quarter 2023 Earnings Conference Call

Retrieved on: 
Thursday, October 5, 2023

SAN ANTONIO, Oct. 5, 2023 /PRNewswire/ -- Cullen/Frost Bankers, Inc. (NYSE: CFR) will host a conference call on Thursday, October 26, 2023 to discuss third quarter 2023 earnings.

Key Points: 
  • SAN ANTONIO, Oct. 5, 2023 /PRNewswire/ -- Cullen/Frost Bankers, Inc. (NYSE: CFR) will host a conference call on Thursday, October 26, 2023 to discuss third quarter 2023 earnings.
  • Earnings Release: The earnings release for Cullen/Frost Bankers, Inc. will be available at approximately 8:00 a.m. Central Time (CT) on the internet at https://investor.frostbank.com/ .
  • Conference Call and Live Webcast: The conference call will begin at 1:00 p.m. CT (2:00 p.m. Eastern) and will be hosted by Phil Green, Chairman and CEO, Jerry Salinas, Group Executive Vice President and CFO and A.B.
  • Following the prepared remarks there will be a question and answer session for the analyst community.

EXPRESSION SYSTEMS INTRODUCES CHEMICALLY DEFINED INSECT CELL CULTURE MEDIUM FOR SUPERIOR PROTEIN EXPRESSION YIELDS

Retrieved on: 
Thursday, October 5, 2023

DAVIS, Calif., Oct. 5, 2023 /PRNewswire/ -- Expression Systems, an Advancion company, today introduced a new, chemically defined insect cell culture medium that offers exceptional performance while improving the consistency and efficiency of gene therapy and other biologics manufacturing processes.  

Key Points: 
  • ESF AdvanCD™ is a 100% chemically defined, animal-origin-free, protein-free, serum-free insect cell culture medium for use in viral vector manufacturing, structural biology and other applications
    DAVIS, Calif., Oct. 5, 2023 /PRNewswire/ -- Expression Systems, an Advancion company, today introduced a new, chemically defined insect cell culture medium that offers exceptional performance while improving the consistency and efficiency of gene therapy and other biologics manufacturing processes.
  • ESF AdvanCD™ chemically defined insect cell culture medium is a proprietary formulation manufactured exclusively by Expression Systems, a leading global provider of specialty cell culture media formulations, cell lines, and contract services for the baculovirus expression platform.
  • The ESF AdvanCD cell culture medium supports scalable baculovirus infection and protein expression in Spodoptera and Trichoplusia cell lines.
  • "ESF AdvanCD cell culture medium is the next generation of Expression Systems' best-in-class products for developing and producing advanced therapies leveraging the productivity advantages of the BEVS platform," said Dr. Thera Mulvania, President, Expression Systems.

GH Research Provides Updates and Guidance on its Clinical Development Program for GH001 in Treatment-Resistant Depression

Retrieved on: 
Friday, September 29, 2023

DUBLIN, Ireland, Sept. 29, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today provided updates and guidance on its clinical development program for GH001, its proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, in treatment-resistant depression (TRD).

Key Points: 
  • DUBLIN, Ireland, Sept. 29, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today provided updates and guidance on its clinical development program for GH001, its proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, in treatment-resistant depression (TRD).
  • The double-blind phase is followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status.
  • We are awaiting that follow-up letter from the FDA and look forward to working with them to resolve any outstanding concerns.
  • We plan to provide an update in our next earnings release in November 2023.