Urinary tract infection

Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

Retrieved on: 
Friday, February 23, 2024

This press release features multimedia.

Key Points: 
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240223169844/en/
    The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam.
  • The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
  • “While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam.

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.

University Medical Devices Raises $1.6 Million in Seed Funding to Launch First-of-its-Kind Nasal Specimen Collection Device for Diagnosing Upper Respiratory Infections

Retrieved on: 
Tuesday, February 20, 2024

University Medical Devices (UMD) today announced the closure of its first round of seed funding.

Key Points: 
  • University Medical Devices (UMD) today announced the closure of its first round of seed funding.
  • Funds are earmarked to advance UMD’s infrastructure, covering regulatory, medical, legal, manufacturing, packaging, sales and marketing.
  • This funding round represents a major step toward UMD achieving profitability and sustainability, with a strong emphasis on bringing its first product – MicroWash – to market.
  • MicroWash plays a pivotal role in addressing the challenges posed by the “tripledemic” – flu, COVID and RSV – as well as other respiratory infections.

SEKISUI Diagnostics Receives Emergency Use Authorization for the OSOM® Flu SARS-CoV-2 Combo Test

Retrieved on: 
Tuesday, March 5, 2024

BURLINGTON, Mass., March 5, 2024 /PRNewswire/ -- SEKISUI Diagnostics, a global medical diagnostics manufacturer, has received EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test for use in professional and home testing settings.

Key Points: 
  • BURLINGTON, Mass., March 5, 2024 /PRNewswire/ -- SEKISUI Diagnostics, a global medical diagnostics manufacturer, has received EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test for use in professional and home testing settings.
  • The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen.
  • As with other OSOM Rapid Tests, it is made in the USA and supported by a highly skilled technical support team of medical technologists/professionals.
  • "The utility of detecting COVID and Flu on one test is now more important than ever having moved into the endemic phase of COVID.

SENA Health Announces Partnership with Inspira Health to Support Hospital-Level Care in the Home

Retrieved on: 
Tuesday, March 5, 2024

PHILADELPHIA, March 5, 2024 /PRNewswire/ -- SENA Health announces its partnership with Inspira Health to support patients receiving Healing at Home clinical services. The home-based services deliver advanced-level care to eligible Inspira Health patients in the comfort of their own homes. The program combines expert care with advanced technology to offer a seamless, integrated service that maximizes health outcomes.

Key Points: 
  • PHILADELPHIA, March 5, 2024 /PRNewswire/ -- SENA Health announces its partnership with Inspira Health to support patients receiving Healing at Home clinical services.
  • The home-based services deliver advanced-level care to eligible Inspira Health patients in the comfort of their own homes.
  • "Inspira Health sets itself apart as a truly innovative and forward-thinking organization in the region," said Dr. Anthony Wehbe, Founder and CEO of SENA Health.
  • Inspira Health, in collaboration with SENA, has recently obtained the CMS Acute Hospital Care at Home Waiver.

Vivacelle Bio Integrates Sub-Saharan Africa Strategy into Series B Financing Round

Retrieved on: 
Thursday, February 22, 2024

Targeted $20M Series B Round to include Sub-Saharan Africa in product development.

Key Points: 
  • Targeted $20M Series B Round to include Sub-Saharan Africa in product development.
  • Vivacelle Bio is partnering with Propelevate to drive the Sub-Saharan Africa strategy, which is fully integrated into its Series B financing round.
  • Through partnership with Propelevate, Vivacelle Bio will engage global health funders and stakeholders during final stages of product development, and Propelevate will drive Vivacelle Bio's go-to-market strategy for African markets upon regulatory approval.
  • "We are excited to partner with Vivacelle Bio because of their commitment to Sub-Saharan Africa.

Bacteria in your gut can improve your mood − new research in mice tries to zero in on the crucial strains

Retrieved on: 
Thursday, February 15, 2024

But can they improve your mood, too?

Key Points: 
  • But can they improve your mood, too?
  • But the short answer, according to my team’s recently published research, is likely yes.
  • The beneficial bacteria in probiotics become part of a community of other microscopic organisms living in your digestive system called the gut microbiome.

Studying mood in mice

  • So how do you measure the mood of mice?
  • We exposed them to poop from either stressed mice or normal mice by sprinkling soiled bedding in their enclosures.
  • Microbes from the donor mice started to populate the gut microbiomes of the clean mice.
  • Within a few weeks, the clean mice exposed to poop from stressed mice started to develop stress- and anxiety-like behavior, even though nothing else had changed.

Which bacteria affect mood?

  • The results of our experiments led us back to our original question: Which bacteria can change your mood?
  • In our analysis, we found that a group of bacteria called Lactobacillus was greatly reduced in the stressed mice.
  • So we had to come up with a way to test how different strains affect anxious behavior.
  • Instead of tackling this colossal task alone, we created a method that other microbiome scientists can also use to look at this group of bacteria as systematically as possible.
  • To recreate the same experimental conditions for each species of microbe, we created a group of mice with only six species of bacteria in their microbiome, the bare minimum needed for normal and healthy development, which did not include Lactobacillus.

What’s next?

  • We hope that our research will open avenues for other scientists to test different probiotics.
  • In the meantime, give the Lactobacillus in your gut some love through a healthy, probiotics-rich diet.


Andrea Merchak has received funding from the National Institutes of Health (T32 NS115657, F31 AI174782).

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Tuesday, February 13, 2024

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

FLEX LOGIX JOINS INTEL FOUNDRY SERVICES ACCELERATOR IP ALLIANCE TO ENABLE FAST, LOW POWER, RECONFIGURABLE SOC'S

Retrieved on: 
Monday, February 12, 2024

MOUNTAIN VIEW, Calif., Feb. 12, 2024 /PRNewswire/ -- Flex Logix® Technologies, Inc., the leading supplier of embedded FPGA (eFPGA) IP and reconfigurable DSP/AI solutions, announced today that it has joined the Intel Foundry Services (IFS) Accelerator IP Alliance. Through the alliance, Flex Logix will now have access to Intel's leading edge process design kits, like Intel 18A, to provide embedded FPGA and reconfigurable DSP/AI solutions for mutual customers.

Key Points: 
  • Brings industry-leading silicon IP from Flex Logix to IFS customers using Intel 18A in data center, edge, 5G, automotive and military-aerospace for many use-cases
    MOUNTAIN VIEW, Calif., Feb. 12, 2024 /PRNewswire/ -- Flex Logix® Technologies, Inc ., the leading supplier of embedded FPGA (eFPGA) IP and reconfigurable DSP/AI solutions, announced today that it has joined the Intel Foundry Services (IFS) Accelerator IP Alliance.
  • Through the alliance, Flex Logix will now have access to Intel's leading edge process design kits, like Intel 18A, to provide embedded FPGA and reconfigurable DSP/AI solutions for mutual customers.
  • "Flex Logix is the leader in embedded FPGA IP with more than 20 licensed customers, more than 40 licensed chips and over 25 chips in silicon," said Geoff Tate, CEO of Flex Logix.
  • We are proud to join the Intel Foundry Services Accelerator IP Alliance and look forward to delivering IP to our mutual customers, enabling the world's most advanced SoCs."

Vaccination, testing, clean air: COVID hasn’t gone away – here’s where Australia needs to do better

Retrieved on: 
Sunday, February 11, 2024

In May 2023 the World Health Organization (WHO) declared COVID was no longer a public health emergency of international concern.

Key Points: 
  • In May 2023 the World Health Organization (WHO) declared COVID was no longer a public health emergency of international concern.
  • But the virus continues to infect millions of people globally and the WHO recognises COVID as an ongoing pandemic.
  • As of February 1 there were 287 outbreaks in residential aged care homes, and people are still dying from the virus.

Vaccination

  • COVID vaccination reduces severe illness and can in turn reduce pressure on the health system.
  • Boosters are important as we know immunity wanes over time, both after infection and vaccination.
  • There’s also no recommendation that people at greater occupational risk of catching COVID, such as health-care workers, childcare workers or emergency and essential services workers receive another vaccination at this stage.
  • Also, although older people are generally at greatest risk from a COVID infection, COVID in younger age groups can still in some cases cause severe and potentially long-term illness (and we know vaccination reduces the risk of long COVID).
  • Recent figures show only 16.6% of people aged between 65 and 74 have received a booster dose in the past six months.
  • The Australian government has recognised the need for a strong vaccination program as a means to minimise levels of severe COVID and death.

Testing

  • While testing is encouraged if you have COVID symptoms, there’s no requirement or incentive to test or report positive results.
  • In New South Wales for example, laboratory confirmed cases are trending downwards while wastewater testing suggests COVID prevalence remains high.

Ventilation

  • In September 2023 the Australasian Health Infrastructure Alliance released guidance on pandemic preparedness.
  • This document calls for the design of any new health-care building to take minimising the risk of infection transmission into account.
  • Strategies to optimise ventilation in buildings must involve early consultation with qualified ventilation specialists who can address requirements such as the air exchange rate relative to the size of the building and number of expected occupants.
  • Mandating this would ensure we build facilities which minimise the transmission of most respiratory infections – not just COVID.

Other things

  • Employers have a responsibility to enable access to paid sick leave, especially for those working with vulnerable communities and in health care.
  • Hand hygiene, although a foundation of infection prevention and control, appears to have less of a role in controlling COVID transmission.
  • Stephane is also the President of the Australasian College for Infection Prevention and Control (ACIPC) and was the recipient of an Early Career Research Grant from ACIPC in 2016.
  • Peta-Anne undertakes contracted consultancies for the World Health Organization and is a focal point for the Global Outbreak Alert and Response Network.
  • Sally is President Elect of the Australasian College for Infection Prevention and Control and a recipient of an ACIPC Early Career Researcher Grant in 2023.