Food and Drug Administration Amendments Act of 2007

City of Hope Opens First U.S. Multicenter Clinical Trial for Robotic Single-Port Mastectomies for Breast Cancer Patients

Retrieved on: 
Tuesday, October 3, 2023
Technology, Health, Women, Oncology, Robotics, Health Technology, Research, Surgery, Consumer, Science, Clinical Trials, Surgical oncology, City of Hope, Surgeon, Clinical trial, Cancer, Lead, Food and Drug Administration Amendments Act of 2007, Urology, Patient, Surgical Innovation, Food, Intuition, Breast cancer, Birth control, City, Hope

City of Hope, one of the largest cancer research and treatment organizations in the United States, is opening a multicenter clinical trial to evaluate the efficacy of robotic-assisted, single-incision mastectomies.

Key Points: 
  • City of Hope, one of the largest cancer research and treatment organizations in the United States, is opening a multicenter clinical trial to evaluate the efficacy of robotic-assisted, single-incision mastectomies.
  • “City of Hope is once again taking the lead in investigating innovations, treatments and therapies that are making big leaps forward for patients with cancer.
  • “City of Hope offers the most advanced breast cancer treatments,” said Jamie Rand , M.D., a breast cancer surgeon at City of Hope and subinvestigator on the clinical trial.
  • Surgeons at City of Hope, a leader in robotic surgery , have performed more than 16,000 nonmastectomy robotic procedures.

Understanding the Power of Patients: Examples of Patient Impact on Clinical Development, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, September 28, 2023
University, Senior, University of Cambridge, Heart, Trial of the century, Patient engagement in Canada, Food and Drug Administration Amendments Act of 2007, Patient, FDA, Food, Caregiver, Medical device, Medical imaging, Takeda, Research

TORONTO, Sept. 28, 2023 /PRNewswire-PRWeb/ -- Patient engagement in clinical development is understood to be beneficial to all stakeholders but it's not easy for companies to figure out how they implement patient feedback in their work.

Key Points: 
  • In this free webinar, learn how to address and provide updated community draft guidance to The Food and Drug Administration (FDA).
  • Attendees will learn best practices for incorporating multiple stakeholders — patients, caregivers, clinicians, researchers, drug companies, genetic counselors and regulatory experts — into guidance efforts.
  • The featured speakers will discuss how to engage with patients to develop digital endpoints that are meaningful to them.
  • In addition, how to address and provide updated community draft guidance to The Food and Drug Administration (FDA) will be discussed.

Microbot Medical Engages CRO to Support its Upcoming U.S. Pivotal Clinical Trial

Retrieved on: 
Wednesday, September 27, 2023
Partnership, ZEUS robotic surgical system, Clinical trial, Contract research organization, Research, Food and Drug Administration Amendments Act of 2007, FDA, Food, Safety, Fine chemical, Pharmaceutical industry

This is an additional step in the preparations to the commencement of the Company's planned upcoming clinical trial.

Key Points: 
  • This is an additional step in the preparations to the commencement of the Company's planned upcoming clinical trial.
  • The CRO will provide an array of comprehensive research management services, leveraging their expertise and resources to bolster Microbot's clinical trial initiatives.
  • The CRO will also furnish guidance throughout the clinical trial process, along with essential functional support and resources, to ensure a seamless execution of the Company's U.S. pivotal clinical trial.
  • The Company's upcoming U.S. pivotal clinical trial has been designed to evaluate the safety and efficacy of the LIBERTY® Robotic Surgical System in endovascular procedures.

Cue Biopharma Announces Completion of Patient Enrollment in Phase 1b Study of CUE-101 in Combination with KEYTRUDA®

Retrieved on: 
Tuesday, September 26, 2023
Papillomaviridae, Neoplasm, Fast Track, Food and Drug Administration Amendments Act of 2007, Patient, Cancer, FDA, Pembrolizumab, ORR, Food, Pharmaceutical industry

“Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration (FDA),” said Daniel Passeri, chief executive officer of Cue Biopharma.

Key Points: 
  • “Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration (FDA),” said Daniel Passeri, chief executive officer of Cue Biopharma.
  • “We believe the updated data will build upon the already promising clinical profile established to date, which has shown an enhancement of clinical efficacy with the CUE-101-pembrolizumab combination compared to pembrolizumab alone.
  • This clinical validation is also being supported by a Phase 1 trial with our second CUE-100 series biologic, CUE-102, for Wilms’ Tumor 1-expressing tumors.
  • Data to date has demonstrated clinical evidence of anti-tumor activity across multiple indications in patients treated in the dose escalation portion of the study, and we look forward to presenting the data at SITC.”

Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (epinephrine) Sublingual Film

Retrieved on: 
Wednesday, September 20, 2023
PK, Tmax, Allergy, Emergency, NDA, Cmax, Food and Drug Administration Amendments Act of 2007, Patient, Anaphylaxis, Adrenaline, FDA, Therapy, Food, Pharmaceutical industry

As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023.

Key Points: 
  • As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023.
  • The Company intends to commence the pivotal trial in the fourth quarter 2023, following alignment with the FDA.
  • In addition, the Company’s current development plan continues to include a standard repeat-dose study of Anaphylm and an already-approved comparator.
  • Further information on this comparison is available in the Company’s corporate presentation located on the Investor page of the Company’s website.

FDA awards nearly $7.5 million to pediatric device consortium led by Children’s National Hospital

Retrieved on: 
Tuesday, September 19, 2023
Walter Reed Army Medical Center, Therapy, Report of the 1st Annual Symposium on Relaxed Improvisation, Elective surgery, University, FDA Center for Devices and Radiological Health, Research, African Americans, Food and Drug Administration Amendments Act of 2007, Acquisition, PDC, Tufts Medical Center, Johns Hopkins University, Mass, Mass General Brigham, AdvaMed, RWE, World Creativity and Innovation Day, Ecosystem, FDA, Health, Device, Conference, Food, Harwell Science and Innovation Campus, Birth control, Pharmaceutical industry

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital .

Key Points: 
  • WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital .
  • New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.
  • Along with Children’s National, APDI consortium members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center and Medstar Health Research Institute.
  • Eskandanian says the new Children’s National Research and Innovation Campus provides the ideal environment for the collaborative work needed to advance pediatric innovation.

IN8bio Strengthens Intellectual Property Portfolio with Newly Granted Global Patents

Retrieved on: 
Tuesday, September 19, 2023
Genetic engineering, GBM, Cancer, Hope, NK, Cell, IP, HSCT, Pharmacotherapy, Food and Drug Administration Amendments Act of 2007, Leukemia, Patient, DRI, CPI-0610, Growth, FDA, Food, Deltex Medical Group, Vaccine, Pharmaceutical industry

IN8bio now holds 19 total granted U.S. and international patents, and numerous pending patent applications.

Key Points: 
  • IN8bio now holds 19 total granted U.S. and international patents, and numerous pending patent applications.
  • NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, today announced significant updates to its foundational IP portfolio.
  • The company was recently granted patents around the world that cover use of the combination of its proprietary DeltEx DRI platform with CAR-T and CPI’s.
  • IN8bio boasts a strong IP portfolio of granted patents encompassing the DRI, CAR-T and HSCT families, with multiple additional applications pending globally to further expand its patent portfolio and IP position.

Redwood Scientific Technologies Inc. (RSCI.OTC.PK) Announces Successful S1 Registration Filing and Provides Updates on TBX FREE Clinical Trial Progress

Retrieved on: 
Monday, September 18, 2023
Institutional review board, Security (finance), Food and Drug Administration Amendments Act of 2007, Clinical trial, FDA, TBX, IRB, Food, Pharmaceutical industry

NEW YORK, Sept. 18, 2023 /PRNewswire/ -- Redwood Scientific Technologies is delighted to announce the successful filing of its S1 registration statement with the Securities and Exchange Commission (SEC).

Key Points: 
  • NEW YORK, Sept. 18, 2023 /PRNewswire/ -- Redwood Scientific Technologies is delighted to announce the successful filing of its S1 registration statement with the Securities and Exchange Commission (SEC).
  • The company has received confirmation from the SEC, affirming the completion of this important milestone.
  • Redwood Scientific Technologies files S1 and updates on Clinical Trial process.
  • Mr. Cardiff further provided updates on the progress of the clinical trials process for TBX FREE and TBX VAPE FREE.

Can at-home DNA tests predict how you'll respond to your medications? Pharmacists explain the risks and benefits of pharmacogenetic testing

Retrieved on: 
Saturday, September 16, 2023
Disulfiram-like drug, DNA, Depression, Genetics, CYP2C19, Citalopram, Cancer, Research, Cell, Bangladesh Technical Education Board, Warfarin, Pharmacist, Food and Drug Administration Amendments Act of 2007, Protein, Drug, Patient, Risk, National, Gene, Tobacco, Pharmacogenomics, Vitamin K, Liver, Knowledge, Safety, Bupropion, Food, Genome, Vaccine, Pharmaceutical industry, Dietary supplement, Generic drug, Antibiotics

This variability in drug response is what pharmacogenomic testing hopes to explain by looking at the genes within your DNA.

Key Points: 
  • This variability in drug response is what pharmacogenomic testing hopes to explain by looking at the genes within your DNA.
  • Pharmacogenomics, or PGx, is the study of how genes affect your response to medications.

How do PGx tests work?

    • PGx tests look for variations within the genes of your DNA to predict drug response.
    • There are commercially available PGx tests that patients can have sent directly to their doorstep with or without the involvement of a health care professional.
    • These direct-to-consumer PGx tests collect DNA from either a saliva sample or cheek swab that is then sent to the laboratory.

Limitations of PGx testing

    • PGx testing will not be able to predict how you will respond to all medications for several reasons.
    • PGx tests can predict how you will respond only to medications associated with the genes it tests for.
    • Some drugs are broken down in very complicated pathways entailing multiple proteins and byproducts, and the usefulness of PGx testing for them remains unclear.
    • In other words, PGx testing is predictive rather than deterministic.

Risks of PGx testing

    • PGx testing carries the risk of not telling the whole story of drug response.
    • If variations within the gene are not found, the testing company often assumes the proteins those genes code for function normally.
    • Sharing your PGx test results with all the clinicians involved in your care can help prevent medication failure and improve safety.

Benefits of PGx testing

    • Direct-to-consumer PGx testing can empower patients to advocate for themselves and be an active participant in their health care by increasing access to and knowledge of their genetic information.
    • Patients’ knowledge of their PGx genetic profile has the potential to improve treatment safety.

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

Retrieved on: 
Tuesday, September 12, 2023
Infection, Biologics license application, KOL, Extremities, Surgeon, File, Amputation, Conference call, Internet, Ligation, Clinical trial, Trauma, Sale, Saphenous, Regenerative Medicine Advanced Therapy, Food and Drug Administration Amendments Act of 2007, Patient, Standard of care, Risk, HUMA, Injury, Peripheral artery disease, FDA, HAV, BLA, Conference, Food, Vaccine, Pharmaceutical industry

DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.

Key Points: 
  • ET today -
    DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.
  • Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.
  • Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft.
  • Human Acellular Vessel (HAV) for Vascular Trauma Repair: Top Line Phase 2/3 V005 Results and KOL Perspectives