Urinary tract infection

Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, February 27, 2024

Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.

Key Points: 
  • Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.
  • Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
  • "Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals.
  • Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013.

Global Cephalosporin Drug Market Forecast to Reach USD 21.9 Billion by 2029: Exceptional Growth in Bacterial Infection Treatments Fuels Market Expansion - ResearchAndMarkets.com

Retrieved on: 
Friday, February 23, 2024

A sterling analysis of the global cephalosporin drug market has been conducted, encapsulating the various segments such as generation, route of administration, and application.

Key Points: 
  • A sterling analysis of the global cephalosporin drug market has been conducted, encapsulating the various segments such as generation, route of administration, and application.
  • This report delves into the current industry patterns, the comprehensive competitive landscape, and the elaborative market dynamics from 2019 to 2029.
  • Highlighting the significance of bacterial infections as a driving force behind the growth of the cephalosporin drug market, the report underscores the increasing global demand for effective antibiotics.
  • With a robust forecast predicting substantial growth, this report is an essential asset for those seeking to navigate the complex pathways of the cephalosporin drug market.

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