Pivotal trial

Paracrine Receives Full FDA Approval of Investigational Device Exemption (IDE) to Launch a U.S. Pivotal Trial in Patients With Diabetic Foot Ulcers

Retrieved on: 
Wednesday, November 17, 2021
Health, FDA, Medical Devices, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Patient, Investigational device exemption, IDE, Sale, Safety, DFU, Technology, Diabetes, Adipose tissue, PMA, American Diabetes Association, Foot, Diabetic foot ulcer, Physician, Treatment, Risk, Biotechnology, Randomness, Pivotal trial, FDA, Ulcer, Pharmaceutical industry, Paracrine, Celution, Diabetic Foot Ulcers, PARACRINE, CELUTION, DIABETIC FOOT ULCERS

The ASCEND Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of ADRCs in the treatment of patients with DFUs.

Key Points: 
  • The ASCEND Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of ADRCs in the treatment of patients with DFUs.
  • The trial will include up to 291 patients at 25 clinical sites in the U.S. Trial results will be submitted in a Premarket Approval (PMA) application to the FDA to support regulatory approval.
  • Paracrine, Inc. is a biotechnology company developing the worlds first device-based autologous multifactorial cell therapy platform to treat debilitating chronic conditions.
  • Diabetic foot ulcers (DFUs) are responsible for more hospital admissions than any other diabetic complication.

Caltrans Is 1 Of Just 7 Winners Of 2021 National Roadway Safety Award

Retrieved on: 
Wednesday, October 6, 2021
Federal Highway Administration, Partnership, Complete streets, Dots, American Highway Users Alliance, Injury, California Department, Fatality, Pivotal trial, Environment, Transport, Program, Pivot, North Carolina, Integration, Safety, Crash, Road, Risk management

WASHINGTON, Oct. 6, 2021 /PRNewswire/ -- The California Department of Transportation, or Caltrans, was honored today with a 2021 National Roadway Safety Award for an intensive 15-month effort that comprehensively updated the state's Strategic Highway Safety Plan (SHSP).

Key Points: 
  • WASHINGTON, Oct. 6, 2021 /PRNewswire/ -- The California Department of Transportation, or Caltrans, was honored today with a 2021 National Roadway Safety Award for an intensive 15-month effort that comprehensively updated the state's Strategic Highway Safety Plan (SHSP).
  • The National Roadway Safety Awards are a biennial awards program sponsored jointly by the Federal Highway Administration and the Roadway Safety Foundation.
  • The seven winners of the National Roadway Safety Award projects were selected from a nationwide pool of applicants and evaluated on three criteria: Effectiveness, Innovation, and Efficient Use of Resources.
  • of Transportation for its long-life pavement markings safety effort;
    Village of Whitefish Bay, WI for its community-wide roadway safety improvements;
    Texas Dept.

Radius Health Business Update

Retrieved on: 
Tuesday, July 27, 2021
Pharmaceutical industry, Health sciences, Pivotal trial, Food and Drug Administration, Medication, Health

To date in 2021, 80+% of our top 50 TYMLOS prescribers are fracture / bone health focused, a trend we see accelerating.

Key Points: 
  • To date in 2021, 80+% of our top 50 TYMLOS prescribers are fracture / bone health focused, a trend we see accelerating.
  • Radius plans to move forward with a seamless Phase 2/3 pivotal trial for PWS.
  • Radius goal: through the pivotal trial and subsequent data readout, demonstrate efficacy and safety for FDA approval, and to help patients living with PWS.
  • Radius is a commercial biopharmaceutical company committed to serving patients with unmet medical needs in endocrinology and other therapeutic areas.

Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial

Retrieved on: 
Monday, June 28, 2021
Clinical trials, Preterm birth, Companies, Pivotal trial, Sanofi, Health, Clinical research, Respiratory syncytial virus

MEDLEY is the third pivotal trial to report positive data for nirsevimab.

Key Points: 
  • MEDLEY is the third pivotal trial to report positive data for nirsevimab.
  • In April, Sanofi reported that nirsevimab met its primary endpoint of achieving a statistically significant reduction of LRTI caused by RSV in healthy preterm and term infants in the Phase 3 MELODY trial.
  • Coupled with recently published Phase 2b trial results, MELODY and MEDLEY results are part of a robust body of evidence demonstrating the potential of nirsevimab to provide RSV protection to all infants.
  • These results, combined with the recent positive efficacy outcome of our MELODY Phase 3 trial and our Phase 2b data, contribute to the body of evidence demonstrating nirsevimabs potential to protect all infants against RSV with one dose.

TRACON Pharmaceuticals Announces Results of Independent Data Monitoring Committee Review of Safety Data from ENVASARC Pivotal Trial

Retrieved on: 
Tuesday, June 1, 2021
Clinical trials, Health sciences, Health, Medical research, Clusters of differentiation, Clinical endpoint, Clinical research, Pivotal trial, PD-L1, Breakthrough therapy

Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year.

Key Points: 
  • Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year.
  • Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials.
  • The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.
  • TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Nicox’s Completes Pre-Defined Enrollment of NCX 4251 Mississippi Phase 2b Blepharitis Trial

Retrieved on: 
Tuesday, June 1, 2021
NicOx, Health, Blepharitis, Clinical trial, Pivotal trial

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that as of today, more than 200 patients, the pre-defined target, have been randomized in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that as of today, more than 200 patients, the pre-defined target, have been randomized in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial.
  • Mississippi is a Phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis.
  • Should NCX 4251 meet this primary efficacy endpoint for blepharitis, the Mississippi trial could represent the first of two pivotal trials needed to support an NDA in the U.S. for the treatment of acute exacerbations of blepharitis.
  • The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis.

Emboline Raises over $55 Million in Series D Funding for Pivotal FDA Clinical Study and Market Launch of the Emboliner™ Embolic Protection Catheter to Minimize Stroke Risk from TAVR

Retrieved on: 
Tuesday, May 25, 2021
Percutaneous aortic valve replacement, Stroke, Pivotal trial, Medicine

This investment will support a planned US-based pivotal trial for FDA approval as well as investigational studies for new indications, and manufacturing and commercial operations for the Emboliner.

Key Points: 
  • This investment will support a planned US-based pivotal trial for FDA approval as well as investigational studies for new indications, and manufacturing and commercial operations for the Emboliner.
  • The Emboliner provides embolic debris protection for all three major cerebral aortic arch vessels as well the kidneys, abdomen and lower body.
  • Unlike partial embolic protection or deflection devices, the Emboliner is designed to capture and remove all debris generated during transcatheter heart procedures.
  • Emboline, Emboliner and SafePass are trademarks of Emboline, Inc.
    View original content to download multimedia: http://www.prnewswire.com/news-releases/emboline-raises-over-55-million-...

Avisa Diagnostics Inc. (Formerly, FogChain Corp.) Announces Closing of Reverse Takeover Transaction

Retrieved on: 
Tuesday, May 4, 2021
Medical specialties, Organ systems, Pharmaceutical industry, Bronchiectasis, Clinical trials, Cystic fibrosis, Investigational device exemption, Avisa, Food and Drug Administration, Pivotal trial, Health

b'NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES.\nSANTA FE, N. M., May 04, 2021 (GLOBE NEWSWIRE) -- Avisa Diagnostics Inc. (formerly, FogChain Corp.) (the \xe2\x80\x9cCompany\xe2\x80\x9d) is pleased to announce the closing of its previously announced reverse takeover transaction (the \xe2\x80\x9cTransaction\xe2\x80\x9d) with Avisa Pharma Inc. (\xe2\x80\x9cAvisa\xe2\x80\x9d).

Key Points: 
  • b'NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES.\nSANTA FE, N. M., May 04, 2021 (GLOBE NEWSWIRE) -- Avisa Diagnostics Inc. (formerly, FogChain Corp.) (the \xe2\x80\x9cCompany\xe2\x80\x9d) is pleased to announce the closing of its previously announced reverse takeover transaction (the \xe2\x80\x9cTransaction\xe2\x80\x9d) with Avisa Pharma Inc. (\xe2\x80\x9cAvisa\xe2\x80\x9d).
  • Person (as defined in in Rule 902(k) of Regulation S under the Securities Act) absent registration or an applicable exemption from the registration requirement.
  • The Company has established clinical proof-of-concept through trials in cystic fibrosis, tuberculosis and community-acquired pneumonia, which demonstrated positive safety and clinical efficacy results.
  • Avisa is planning pivotal trials in Post-COVID-19 bronchiectasis and ventilator-associated pneumonia and plans to submit Investigational Device Exemption applications to the U.S. FDA for these trials next year.

Satsuma Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 25, 2021
Clinical trials, Pivotal trial

The new Phase 3 trial will take into account our findings from analyses of the EMERGE Phase 3 pivotal trial results.

Key Points: 
  • The new Phase 3 trial will take into account our findings from analyses of the EMERGE Phase 3 pivotal trial results.
  • In conjunction with its March 2021 STS101 development plan update, the Company reported preliminary results to date from the ASCEND trial.
  • Net losses for the fourth quarter and full year 2020 were $12.5 million and $47.6 million, respectively, or $0.72 and $2.73 per common share, respectively.
  • Including the recent financing, the Company believes it has sufficient financial resources to fund operations into the second half of 2023.

Citius Pharmaceuticals to Highlight its Phase 3 Clinical Trial Product Mino-Lok® at Benzinga Biotech Small Cap Conference on March 25

Retrieved on: 
Tuesday, March 23, 2021
Bacterial diseases, Medicine, Medical specialties, Bloodstream infections, Sepsis, Clinical medicine, Catheter, Mino, Antibiotic, Pivotal trial

During the corporate presentation, Mr. Mazur will discuss the Company's Phase 3 program for its lead product candidate Mino-Lok, an antibiotic lock solution being developed to treat patients with catheter-related bloodstream infections (CRBSIs).

Key Points: 
  • During the corporate presentation, Mr. Mazur will discuss the Company's Phase 3 program for its lead product candidate Mino-Lok, an antibiotic lock solution being developed to treat patients with catheter-related bloodstream infections (CRBSIs).
  • "We are eagerly awaiting the third interim efficacy analysis from our independent Drug Monitoring Committee regarding the Mino-Lok Phase 3 trial in progress," said Mr. Mazur.
  • "This pivotal trial is progressing according to plan, and we expect full enrollment this year.
  • Citius issued its most recent Letter to Shareholders in February, highlighting recent updates on its business and clinical developments as well as news for its pipeline of products.