GFR

CalciMedica Announces FDA Clearance of IND Application for Phase 2 Trial of Auxora™ for the Treatment of Severe Acute Kidney Injury

Retrieved on: 
Tuesday, February 13, 2024

LA JOLLA, Calif., Feb. 13, 2024 /PRNewswire/ -- CalciMedica, Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, Auxora™, a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.

Key Points: 
  • CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.
  • "Through KOURAGE, we aim to determine how Auxora can benefit patients with severe AKI and potentially reduce the high mortality rate associated with this disease."
  • AKI is classified as stages 1, 2 and 3 depending on the degree of kidney injury.
  • A single dose of Auxora after IRI increased GFR by 61% and decreased mononuclear (inflammatory) cell infiltration by 30%.

NANO Nuclear Energy Chief Executive Officer to Present Before New Hampshire Commission Investigating the Implementation of Next Generation Nuclear Reactor Technology in the State

Retrieved on: 
Monday, October 16, 2023

New York, N.Y., Oct. 16, 2023 (GLOBE NEWSWIRE) -- NANO Nuclear Energy Inc. (“NANO Nuclear”), an emerging microreactor and advanced nuclear technology company led by a world-class nuclear engineering team developing proprietary, portable and carbon free energy solutions, is pleased to announce that Chief Executive Officer James Walker will provide counsel and testimony on November 6th, 2023 alongside fellow experts in the field for New Hampshire’s Commission To Investigate The Implementation Of Next Generation Nuclear Reactor Technology on the state-wide implementation of new-generation technologies, including “Generation IV” reactors.

Key Points: 
  • “New Hampshire has a plethora of experience with nuclear energy, but I would like to thank NANO Nuclear and Mr. Walker for contributing to our inquiry into advanced nuclear technologies, including Generation IV reactors and microreactors,” said Rep. Keith Ammon, New Hampshire State Representative and Chair, Nuclear Technology Study Commission.
  • Established under HB543, a bill sponsored by New Hampshire State Representatives including Rep. Keith Ammon (R-New Boston), the commission is tasked with assessing developments in nuclear energy technology, notably Generation IV reactors.
  • “At the start of this year, we were encouraged by the Federal government's commitment to advancing the domestic nuclear energy sector,” said James Walker, Chief Executive Officer of NANO Nuclear Energy.
  • “It is time to move past the stigmas of the past when it comes to nuclear energy, and I applaud New Hampshire for taking a proactive stance in investigating our novel nuclear technologies.”

ILUS Finalizes Acquisition and Provides Shareholder Update

Retrieved on: 
Friday, October 6, 2023

ILUS’ Industrial subsidiary, Quality Industrial Corp. (QIND), successfully filed its S-1 Registration Statement on the 19th of September, 2023.

Key Points: 
  • ILUS’ Industrial subsidiary, Quality Industrial Corp. (QIND), successfully filed its S-1 Registration Statement on the 19th of September, 2023.
  • We now look forward to announcing our next strategic acquisition and exhibiting results of the progress made in our businesses,” added ILUS CEO, Nicolas Link.
  • During the third quarter, ILUS finalized the strategy and administrative procedures to spin out several of its public safety businesses into Emergency Response Technologies (ERT), which is wholly owned by ILUS.
  • ILUS wishes to inform Shareholders that its next Annual Shareholder Meeting will take place in Miami on Friday the 26th of January, 2024.

EQS-News: New Formula Leverages Proenkephalin A 119-159 (penKid) for Improved GFR Estimation in Steady-State and Critically Ill Patients

Retrieved on: 
Tuesday, October 17, 2023

PenKid is a kidney function biomarker that correlates with gold standard GFR measurements in stable and acute kidney injury (AKI) patients.

Key Points: 
  • PenKid is a kidney function biomarker that correlates with gold standard GFR measurements in stable and acute kidney injury (AKI) patients.
  • Based on penKid, a new formula was developed to estimate the GFR, outperforming widely used conventional equations based on creatinine alone.
  • Hennigsdorf/Berlin, Germany, October 5, 2023 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces that a new, improved formula has been developed for estimating the GFR using its kidney function biomarker penKid (1).
  • According to the data, penKid strongly correlates with the measured GFR (mGFR), while the penKid-based formula for estimating GFR performs better than routinely used equations.

DaVita Statement on GLP-1 and Potential Implications on Chronic Kidney Disease

Retrieved on: 
Thursday, October 12, 2023

The following statement can be attributed to Dr. Jeff Giullian, chief medical officer for DaVita Inc.

Key Points: 
  • The following statement can be attributed to Dr. Jeff Giullian, chief medical officer for DaVita Inc.
    "We've been closely monitoring the developments related to GLP-1s, and are excited about the potential benefits this class of drugs could have on society and patients with kidney disease.
  • We will continue monitoring closely as further evidence becomes available to identify the potential benefit of GLP-1s to those afflicted with kidney disease.
  • In the meantime, DaVita remains focused on providing exceptional patient care and advancing the practice of kidney care."
  • The trial sought to demonstrate benefits for the composite endpoint comprised of five separate endpoints: death from kidney disease; death from cardiovascular disease; sustained reduction in GFR by at least 50%; progression to stage 5 CKD; and initiation of chronic kidney replacement therapy.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Retrieved on: 
Wednesday, September 27, 2023

STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Key Points: 
  • STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.
  • Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023.
  • "We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products," said CEO Renée Aguiar-Lucander.
  • Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Retrieved on: 
Wednesday, September 27, 2023

STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Key Points: 
  • STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.
  • Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023.
  • "We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products," said CEO Renée Aguiar-Lucander.
  • Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen.

Arkstone Medical Solutions Launches Breakthrough OneChoice Report for Microbiology Lab Results

Retrieved on: 
Thursday, August 24, 2023

BOCA RATON, Fla., Aug. 24, 2023 /PRNewswire/ -- Arkstone Medical Solutions, a trailblazer in laboratory infectious disease reporting and proactive antimicrobial stewardship, has unveiled its latest innovation—the OneChoice report for microbiology lab results. Building on the success of its molecular lab results OneChoice report, which has already benefited hundreds of thousands of patients and is trusted by thousands of healthcare providers, Arkstone now extends its revolutionary technology to the wider realm of microbiology. 

Key Points: 
  • BOCA RATON, Fla., Aug. 24, 2023 /PRNewswire/ -- Arkstone Medical Solutions, a trailblazer in laboratory infectious disease reporting and proactive antimicrobial stewardship, has unveiled its latest innovation—the OneChoice report for microbiology lab results.
  • Building on the success of its molecular lab results OneChoice report, which has already benefited hundreds of thousands of patients and is trusted by thousands of healthcare providers, Arkstone now extends its revolutionary technology to the wider realm of microbiology.
  • "With the launch of the OneChoice report for microbiology lab results, Arkstone is poised to make an even greater impact on the healthcare landscape," said Dave Gross, Co-Founder & CTO of Arkstone.
  • The OneChoice report for microbiology lab results solidifies Arkstone's role as the leading provider of laboratory infectious disease reporting and proactive antimicrobial stewardship.

Crowley, GFR Media Carry Roberto Clemente's Legacy Forward

Retrieved on: 
Friday, August 18, 2023

JACKSONVILLE, Fla., Aug. 18, 2023 /PRNewswire-PRWeb/ -- Longtime Puerto Rico shipping and logistics company Crowley has partnered with El Nuevo Día to amplify the legacy of Roberto Clemente Walker— from San Juan to Pittsburgh and beyond. This comes as the Pittsburgh Pirates and Clemente family prepare to welcome "3,000," a photographic exhibit dedicated to honoring the Hall-of-Famer, humanitarian, and beloved Puerto Rican hometown hero.

Key Points: 
  • JACKSONVILLE, Fla., Aug. 18, 2023 /PRNewswire-PRWeb/ -- Longtime Puerto Rico shipping and logistics company Crowley has partnered with El Nuevo Día to amplify the legacy of Roberto Clemente Walker— from San Juan to Pittsburgh and beyond.
  • "As Puerto Rico's longest serving U.S. shipping and logistics company, we are grateful to carry forward the humanitarian legacy of a beloved national hero by delivering the '3,000' exhibit from Puerto Rico to Pittsburgh," said Sal Menoyo, vice president of Puerto Rico and Caribbean logistics, Crowley.
  • I am certain that Pittsburgh will welcome '3,000' with the same sense of pride as they would celebrating one of the city's hometown heroes," said Pedro Zorrilla, CEO of GFR Media.
  • On behalf of my family, we are grateful to GFR and El Nuevo Día, for documenting his life and the milestone 3,000th hit so beautifully while shining a light on his legacy," said Luis Roberto Clemente, son of the late Roberto and Vera Clemente and director of the Roberto Clemente Foundation Legacy Program.

Fresenius Kabi Further Expands Radiology Portfolio with Launch of Gadobutrol Injection

Retrieved on: 
Tuesday, August 8, 2023

Fresenius Kabi Gadobutrol Injection, a high-relaxivity macrocyclic agent, is available immediately in the United States.

Key Points: 
  • Fresenius Kabi Gadobutrol Injection, a high-relaxivity macrocyclic agent, is available immediately in the United States.
  • It is the second MRI offering in the company’s growing radiology portfolio , which also includes:
    "Fresenius Kabi is pleased to introduce Gadobutrol Injection as the newest addition to our U.S. radiology portfolio, expanding the range of cost-effective contrast agent options available to hospitals and clinics," said John Ducker, president and CEO of Fresenius Kabi USA.
  • Gadobutrol Injection is a gadolinium-based contrast agent indicated for use with MRI.1 It is the fourth product offering in the Fresenius Kabi radiology portfolio, which first launched in July 2022 with the introduction of Iodixanol Injection, USP during a nationwide shortage.
  • Fresenius Kabi Gadobutrol Injection is preservative-free, and the container closure is not made with natural rubber latex.