Mucositis

GlycoMimetics Announces Results of Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Retrieved on: 
Lundi, mai 6, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Mucositis, FAI, Patient, Mitoxantrone, Survival, Etoposide, Research, AML, Cytarabine, MEC, Incidence, Idarubicin, Acquisition, NCI, Inflammation, Cancer

In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.

Key Points: 
  • In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.
  • Patients treated with uproleselan had a median overall survival of 13 months, compared to 12.3 months in the placebo arm.
  • Adverse events were consistent with known side effect profiles of chemotherapy used in the study.
  • The randomized, controlled study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7+3) versus chemotherapy alone.

ChemoMouthpiece, LLC. Announces the Awarding of the 510(k) Marketing Clearance by the FDA for their Oncology Supportive Care Device and Recent Closing of their Private Placement Round

Retrieved on: 
Jeudi, février 22, 2024
Vasoconstriction, Incidence, Marketing, ONS, Oncology Nursing Society, Multimedia, ASCO, FDA, News, Pain, Hodgkin lymphoma, Cryotherapy, Nausea, Manuscript, Risk, Mouth, Society, Wastewater treatment, Patient, Chemotherapy, Clinical trial, Lymphoma, Mucositis, Dentistry

announces the FDA 510(k) Marketing Clearance for their device, The Chemo Mouthpiece™.

Key Points: 
  • announces the FDA 510(k) Marketing Clearance for their device, The Chemo Mouthpiece™.
  • has just closed on their Private Placement Round of $10 million in upfront capital with a full commitment for the second tranche of additional funds in excess of $10 million.
  • "Chemo Mouthpiece™ is fully stocked, as we will begin shipping across the US within the next quarter now that we have FDA Marketing Clearance.
  • ChemoMouthpiece, LLC is a privately held medical device company that develops and commercializes propriety oral cryotherapy products for cancer patients.

FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

Retrieved on: 
Lundi, janvier 8, 2024
Vasculitis, Disease, Food, FDA, NDA, Doctor of Philosophy, Aphthous stomatitis, Shirin David, Conditional sentence, Patient, Radiation, Fast Track, Skin, Mucositis, Pharmaceutical industry

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.

Key Points: 
  • Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.
  • Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics.
  • "We are very pleased to have SGX945 in Behçet's Disease granted fast track designation from the FDA," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
  • "As demonstrated by the granting of the designation, our previous studies with dusquetide in oral mucositis have clearly validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation.

Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Date of authorisation: 12/11/1996, Revision: 39, Status: Authorised

Retrieved on: 
Mardi, janvier 2, 2024
Marketing, Constipation, INN, Leukopenia, Woman, Carcinoma, Lung cancer, Fatigue, Nausea, DNA, Cancer, Neoplasm, Infection, SCLC, Mouth ulcer, Risk management, Anatomy, Paclitaxel, IIA, CHMP, Diarrhea, Fever, ATC, Capsule, European, Disease, Weakness, Mucositis, Anemia, Medical Subject Headings, Febrile neutropenia, European Commission, Cyclophosphamide, Vincristine, International, Neutropenia, Somatic symptom disorder, Aplastic anemia, Language, Cisplatin, Thrombocytopenia, Medication, Select, Patient, Medicine, Vomiting, Ovary, Survival, Ovarian cancer, Cervical cancer, Hair loss, Radiation, Doxorubicin, Committee, Medical device

Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Date of authorisation: 12/11/1996, Revision: 39, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Date of authorisation: 12/11/1996, Revision: 39, Status: Authorised

KAZIA ANNOUNCES THE RELEASE OF PNOC022 CLINICAL STUDY ABSTRACT HIGHLIGHTING PAXALISIB IN DIFFUSE MIDLINE GLIOMA PATIENTS AHEAD OF THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

Retrieved on: 
Mercredi, novembre 15, 2023
DRD2, Annual general meeting, Therapy, Eosinophilia, Disulfiram-like drug, Lymphocyte, Patient, KZIA, PNOC, Colitis, Mucositis, MD, Trial of the century, Diagnosis, DMG, Hyperglycemia, ONC201, Physician, OS, Society, Hypokalemia, DMG interpersonal, Pharmaceutical industry

The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.

Key Points: 
  • The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.
  • Sixty-eight children and young adults with DMG who completed standard of care radiation treatment received paxalisib (an investigational PI3K-mTOR dual inhibitor) and ONC201 (an investigational dopamine receptor D2 (DRD2) and ClpP agonist).
  • The abstract reported that median overall survival (OS) from time of diagnosis was 16.5 months.
  • "The PNOC022 study has exceeded expectations in terms of enrolment rates and has partnered with 29 leading children's cancer centers and physicians across the globe."

Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem

Retrieved on: 
Lundi, septembre 18, 2023
Therapy, Classification, Symantec Endpoint Protection, NDA, Cancer, Head, Mucositis, Type, SOM, Patient, CRL, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

The FDA is expected to issue written meeting minutes approximately 30 days following the meeting.

Key Points: 
  • The FDA is expected to issue written meeting minutes approximately 30 days following the meeting.
  • "We look forward to further understanding the FDA’s review of our NDA for avasopasem and the data from our two randomized placebo-controlled clinical trials,” said Mel Sorensen, M.D., Galera’s President and CEO.
  • “We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis.
  • The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.

Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

Retrieved on: 
Mercredi, août 9, 2023
Workforce, Pancreatic cancer, SBRT, Therapy, Symantec Endpoint Protection, Survival, Clinical trial, NDA, Cancer, Head, Mucositis, Lung cancer, SOM, Radiation, GRECO, Patient, Diagnosis, CRL, FDA, Galera, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

MALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment.

Key Points: 
  • The Company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem.
  • “This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” said Mel Sorensen, M.D., Galera’s President and CEO.
  • The Company will focus resources to define the path forward for avasopasem and to progress the ongoing clinical trials for rucosopasem.
  • The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.

VANFLYTA® Now Available in U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Mercredi, août 9, 2023
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Neutropenia, REMS, Maintenance, Hypermagnesemia, Cardiac arrest, Febrile neutropenia, Hypophosphatemia, Magnesium, Diarrhea, Mitigation, Hypocalcemia, Pharmacy, Food, QT interval, Indigestion, ECG, HSCT, Abdominal pain, QT, Sepsis, Acute myeloid leukemia, Alkaline phosphatase, Vomiting, Insomnia, AML, Lymphocytopenia, Patient, NE, Physician, Risk, Hypokalemia, Daiichi Sankyo, Anemia, HR, CR, Mucositis, Nausea, Hypernatremia, FLT3, Fungal infection, Upper respiratory tract infection, Lancet, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Safety, Headache, Thrombocytopenia, Nosebleed, Hyperkalemia, TSE, Disease, Pharmaceutical industry, Hypoalbuminemia

VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.

Key Points: 
  • VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.
  • The results of QuANTUM-First were published in The Lancet .1
    The safety of VANFLYTA was evaluated in 265 patients with newly diagnosed FLT3-ITD positive AML who received VANFLYTA once daily (35.4 mg with chemotherapy, 26.5 to 53 mg as maintenance) in the QuANTUM-First trial.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.
  • Provider and patient support and information regarding distribution, access, and reimbursement are now available through Daiichi Sankyo Access Central by visiting www.DSIAccessCentral.com or calling 1-866-4-DSI-NOW (1-866-437-4669).

VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Jeudi, juillet 20, 2023
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Magnesium, QT interval, Doctor of Philosophy, Alkaline phosphatase, Patient, Division, Risk, Daiichi Sankyo, HR, Leukemia, Nosebleed, Thrombocytopenia, REMS, Maintenance, Febrile neutropenia, Diarrhea, Pharmacy, Duke Cancer Institute, Sepsis, Vomiting, FLT3, Fungal infection, Lancet, Death, Headache, Safety, Neutropenia, Cardiac arrest, Indigestion, ECG, Abdominal pain, Acute myeloid leukemia, Insomnia, Lymphocytopenia, Anemia, CR, Mucositis, Hypermagnesemia, Hyperkalemia, Hypophosphatemia, Mitigation, Hypocalcemia, HSCT, QT, Bone marrow, AML, NE, Hypokalemia, Nausea, Hypernatremia, Upper respiratory tract infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, TSE, Pharmaceutical industry, Nursing, MD, Hypoalbuminemia

VANFLYTA will be available by prescription in the U.S. in the coming weeks.

Key Points: 
  • VANFLYTA will be available by prescription in the U.S. in the coming weeks.
  • VANFLYTA is approved with a Boxed WARNING for QT prolongation, torsades de pointes and cardiac arrest.
  • The FDA concurrently approved a companion diagnostic test to detect FLT3-ITD mutations in patients with newly diagnosed AML.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.

A pneumonia-causing bug disappeared during the pandemic – but a surge may come this winter

Retrieved on: 
Jeudi, juillet 13, 2023
Infection, Asthma, Urinary tract infection, Kidney, Wheeze, Fever, Tonsillitis, Immunity, Brain, COVID, Diarrhea, Respiratory syncytial virus, Mycoplasma, Sinusitis, Vomiting, Epidemic, School, RSV, Hospital, Swelling, Mycoplasma pneumoniae, Mucositis, Sneeze, Bacteria, Headache, Scarlet fever, Virus, Sore throat, Pneumonia, Mouth, Fatigue, Vaccine, Pharmaceutical industry

There were record numbers of people infected with respiratory syncytial virus (RSV), flu and even strep A.

Key Points: 
  • There were record numbers of people infected with respiratory syncytial virus (RSV), flu and even strep A.
  • But the latest data suggests a surge in infections may be coming this winter.
  • It typically causes a mild chest infection, but it can cause life-threatening illness, such as pneumonia and brain swelling.
  • As with other respiratory infections, M pneumoniae is transmitted when an infected person coughs or sneezes, creating “respiratory droplets”.
  • Crowded places, such as schools and hospitals, are ideal environments for the bug to spread.

Potential resurgence

    • But, contradicting these trends, between April 2021 and March 2022 – when most other respiratory infections had made a comeback- – M pneumoniae infections remained largely absent.
    • Data from 212,207 diagnostic tests collected from 42 sites across 23 countries identified only 214 samples positive for M pneumoniae (0.1% of the samples).
    • The reasons for this lack of resurgence are not fully understood and are probably due to many factors.
    • M pneumoniae infections are known to peak and trough, with epidemics occurring every four to six years as alternative variants circulate.