Pseudomonas aeruginosa

Recce Pharmaceuticals Granted New Patent in Israel for RECCE® Anti-Infectives

Retrieved on: 
Thursday, April 4, 2024

SYDNEY, Australia, April 04, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced that the State of Israel Patent Office has formally granted Recce a new family four patent (patent number: 295116), “Process for Preparation of Biologically Active Copolymer Comprising an Acrolein Derivative and a Polyalkylene Glycol Oligomer,” with expiry in 2041.

Key Points: 
  • SYDNEY, Australia, April 04, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced that the State of Israel Patent Office has formally granted Recce a new family four patent (patent number: 295116), “Process for Preparation of Biologically Active Copolymer Comprising an Acrolein Derivative and a Polyalkylene Glycol Oligomer,” with expiry in 2041.
  • “We are thrilled to have received this newly granted patent in Israel,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • Israel’s pharmaceuticals and biotechnology market has a reputation for high R&D spending and an impressive international reach, with world-class export numbers and a growing market value.
  • Other examples include influenza A, Ross River virus, and coronaviruses, including those responsible for severe acute respiratory syndrome and SARS-CoV-2 (COVID-19).

BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, April 3, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Initial top line results of the Phase 2 trial are expected in the first quarter of 2025.
  • However, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
  • ET to discuss its fourth quarter and full year 2023 financial results and to provide a corporate update.

To Bolster Global Efforts in Combating Antibiotic-Resistant Bacteria KFSH&RC Scientists Discover New Bacteria Species: Riyadhensis

Retrieved on: 
Monday, March 25, 2024

RIYADH, Saudi Arabia, March 25, 2024 (GLOBE NEWSWIRE) -- In a ground-breaking development, scientists at King Faisal Specialist Hospital and Research Centre (KFSH&RC) have identified a new species of bacteria, referred to as "Stenotrophomonas Riyadhensis" through the application of whole-genome sequencing (WGS) technology. This discovery signifies a major advancement in understanding how bacteria interact with existing drugs, paving the way for innovative therapeutic strategies. Such efforts are essential in the global fight against antibiotic-resistant bacteria, highlighting KFSH&RC’s advanced research capabilities and its leading role in fostering scientific discoveries and enhancing patient care.

Key Points: 
  • This discovery signifies a major advancement in understanding how bacteria interact with existing drugs, paving the way for innovative therapeutic strategies.
  • Such efforts are essential in the global fight against antibiotic-resistant bacteria, highlighting KFSH&RC’s advanced research capabilities and its leading role in fostering scientific discoveries and enhancing patient care.
  • This represents substantial progress in combating antibiotic resistance, developing pharmaceuticals, and preventing the spread of diseases.
  • Furthermore, this approach lays the groundwork for scientific collaboration at all levels, enhancing global efforts to combat antibiotic resistance.

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

Retrieved on: 
Wednesday, March 13, 2024

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points: 
  • “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
  • Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
  • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
  • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Retrieved on: 
Monday, March 25, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
  • “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics.
  • “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”
    The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
  • For full prescribing information, see package insert located here .

BiomX Announces Entry into Merger Agreement with Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Retrieved on: 
Wednesday, March 6, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 06, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that it has entered into a definitive merger agreement with Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections (the “Acquisition”). Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT. The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement. Concurrently with entering into the definitive merger agreement, BiomX entered into a definitive purchase agreement for the sale of shares of newly created non-voting convertible preferred stock (“Series X Preferred Stock”) and warrants to purchase shares of BiomX common stock in a private placement to certain institutional accredited investors led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital. The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses. The proceeds from the private placement are expected to provide funding through the results from a planned Phase 2b trial that will evaluate BiomX’s lead product candidate, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) in CF patients expected in the third quarter of 2025 and Phase 2 results from APT’s clinical-stage product candidate, now named BX211, for the treatment of Staphylococcus aureus (S. aureus) infections in DFO patients expected in the first quarter of 2025. The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

Key Points: 
  • Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT.
  • The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement.
  • The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses.
  • The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3 CERTAIN-1 Study of Patients with Complicated Urinary Tract Infection

Retrieved on: 
Tuesday, February 20, 2024

Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.

Key Points: 
  • Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.
  • The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240220917017/en/
    “Gram-negative infections such as cUTI have become increasingly difficult to treat due to acquired bacterial resistance to multiple classes of antibiotics.

Vast Therapeutics Expands Leadership Team with Appointment of Dr. Paul Bruinenberg as Chief Medical Officer

Retrieved on: 
Thursday, March 7, 2024

MORRISVILLE, N.C., March 7, 2024 /PRNewswire/ -- Vast Therapeutics today announced the addition of Paul Bruinenberg, MD, MBA as Chief Medical Officer. Dr. Bruinenberg brings over 30 years of experience as a clinical development executive in respiratory medicine and orphan diseases. This appointment and the recent addition of microbiologist and clinical diagnostics expert Chris Polage, MD, as Medical Director, significantly bolster the company's clinical development expertise in pulmonary infectious diseases and medical microbiology. 

Key Points: 
  • MORRISVILLE, N.C., March 7, 2024 /PRNewswire/ -- Vast Therapeutics today announced the addition of Paul Bruinenberg, MD, MBA as Chief Medical Officer.
  • "Paul's development experience will guide Vast Therapeutics as we successfully transition to a clinical-stage organization," said Nate Stasko, Chief Executive Officer at Vast Therapeutics.
  • "It is an amazing opportunity to join a company with an accepted IND for a novel treatment modality that shows promising efficacy against chronic infections caused by Pseudomonas aeruginosa and non-tuberculosis mycobacteria," commented Paul Bruinenberg, Chief Medical Officer at Vast Therapeutics.
  • Most recently, Dr. Bruinenberg served as the Senior Medical Officer of the TB Alliance leading clinical development against mycobacterial infections.

LG UNVEILS BRAND-NEW DUALCOOL AIR CONDITIONER AT MCE 2024 IN MILAN

Retrieved on: 
Thursday, March 7, 2024

SEOUL, South Korea, March 7, 2024 /PRNewswire/ -- LG Electronics (LG) is revealing its efficient, new DUALCOOL™ residential air conditioner at MCE 2024 – one of Europe's biggest heating, ventilation and air conditioning (HVAC) exhibitions – in Milan, Italy, from March 12-15. Leveraging LG's latest air conditioning technologies, including the comfort-enhancing Soft Air™ function, the new DUALCOOL provides a year-round pleasant indoor environment.

Key Points: 
  • Latest DUALCOOL Model Boasts Sophisticated Design, Company's DUAL Vane System, and the Comfort-Enhancing Soft Air Feature
    SEOUL, South Korea, March 7, 2024 /PRNewswire/ -- LG Electronics (LG) is revealing its efficient, new DUALCOOL™ residential air conditioner at MCE 2024 – one of Europe's biggest heating, ventilation and air conditioning (HVAC) exhibitions – in Milan, Italy, from March 12-15.
  • With its sophisticated 'interior fit' design and refined matte finish, the latest LG DUALCOOL air conditioner is a stylish addition to the home.
  • Incorporating the innovative DUAL Vane™ system, the LG DUALCOOL air conditioner sends warm or cool air in multiple directions to deliver fast, effective temperature control.
  • The new LG DUALCOOL air conditioner is set to launch in Italy on April, with availability in other EU countries.

T2 Biosystems Receives FDA 510(k) Clearance for the Expanded T2Bacteria Panel

Retrieved on: 
Monday, February 12, 2024

LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.

Key Points: 
  • LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.
  • “We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The FDA-cleared T2Bacteria Panel now detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli, and A. baumannii.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.