Leukopenia

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

Retrieved on: 
Saturday, February 17, 2024
Penta, Committee, Infection, Leukopenia, Lotilaner, Atopic dermatitis, Cattle, Dog, Sheep, CVMP, InterDigital, Skin, Viral, Hyperthermia, Metritis, Chicken, Horse, Viremia, Classification, Drinking water, Cat, QRD, Guideline, The Committee

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.

Key Points: 
  • The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
  • The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).
  • Concept papers, guidelines
    Quality
    The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.
  • The comments received during the consultation procedure were taken into account for the revision of the annex.

Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update

Retrieved on: 
Wednesday, February 14, 2024
Investigational New Drug, Peripheral edema, Anemia, Gastroenteritis, Medicine, Periodic breathing, Leukopenia, Diarrhea, Quality of life, Cough, Dizziness, Deep vein thrombosis, Nausea, Vomiting, DVT, Common, Tremor, Back pain, Constipation, Safety, Dexamethasone, First grade, Lower respiratory tract infection, URTI, Bronchitis, Therapy, Fatigue, Bortezomib, Pharmacokinetics, Thrombocytopenia, Rash, Patient, Neutropenia, Acceleration, Multiple myeloma, RMOC, IND, Insomnia, Lenalidomide, Appetite, Abdominal pain, Weakness, Pharmaceutical industry

The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).

Key Points: 
  • The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).
  • Remarkably, the trial is progressing ahead of schedule and with the addition of RMOC is now projected to conclude enrollment by Q1/2024.
  • I’m excited about the potential opportunity STAR-LLD can bring to multiple myeloma patients.”
    Earlier last month, Starton disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma.
  • Notably, no hematologic toxicities greater than Grade 1 have been observed following up to 3 cycles of treatment thus far.

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

Retrieved on: 
Friday, February 2, 2024
Partnership, Conjunctivitis, Medicine, Inflammation, Vitamin, Thrombocytopenia, Immune system, Tyrosine, Patient, Light, Nosebleed, Intellectual disability, Itch, Ageing, Diet, Keratitis, Skin, Pharmacy, Tongue, Rash, DSM-IV codes, Allergy, Blood, Leukopenia, Photophobia, Mouth ulcer, Phenylalanine, Erythroderma, Tell, Insurance, Face, Breast milk, Plasma, Nursing

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Takeda’s GAMMAGARD LIQUID® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, CIDP, Rasch, Patient, Chronic inflammatory demyelinating polyneuropathy, Facial muscles, Paresthesia, Common, Leukopenia, Neutropenia, Anemia, Migraine, University, Abdominal pain, Chills, Head, Recombinant, Tremor, Food, Safety, Antibody, Pain, Neurology, Weakness, Headache, IVIG, Somnolence, Vomiting, Trial of the century, Dizziness

“Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”

Key Points: 
  • “Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”
    The approval is based on results from a prospective, open-label, single-arm, multicenter clinical study (ADVANCE-CIDP 2) that evaluated the efficacy and safety of GAMMAGARD LIQUID in adults with CIDP who developed a relapse in the randomized, double-blinded, placebo-controlled study evaluating efficacy, safety and tolerability of HYQVIA (ADVANCE-CIDP 1) in adults with CIDP.
  • Efficacy in ADVANCE-CIDP 2 was based on responder rate, where a responder was defined as a subject who demonstrated an improvement of functional disability.
  • The responder rate was 94.4% (N=18, 95% CI: 74.2% to 99.0%).
  • “Because CIDP is a progressive and complex disease, multiple treatment options are needed, and clinicians now have an additional therapy that can help adults with CIDP manage their disease.”
    GAMMAGARD LIQUID is the only IVIG with multiple neuromuscular disorder indications in the U.S. since it is now approved for CIDP and it is the only FDA-approved IVIG to treat multifocal motor neuropathy as a maintenance therapy to improve muscle strength and disability in adults.1 It is also indicated in the U.S. as a replacement therapy for people two years of age or older living with primary immunodeficiency.1

ASCO GI 2024: Golden Biotech's Antroquinonol Shows Significantly Prolonged Survival in Untreated Metastatic Pancreatic Cancer Patients

Retrieved on: 
Thursday, January 18, 2024
Hope, Pancreatic cancer, Patient, Incidence, OS, Leukopenia, Clinical trial, Neutropenia, Standard of care, ASCO, Survival, Anemia, Thrombocytopenia, Society, Cancer, Liver cancer, EMA, ODD, SOC, FOLFIRINOX, Aes, Lung, Hepatocellular carcinoma, PFS, FDA, Paclitaxel, Committee, AML, GBC, Acute myeloid leukemia, Pharmaceutical industry

Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options.

Key Points: 
  • Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options.
  • The ASCO Gastrointestinal Cancers Symposium 2024 Committee has selected Golden Biotech's Phase 2 Study, titled "A Phase I/II study of Antroquinonol in combination with Nab-Paclitaxel and Gemcitabine for patients with metastatic pancreatic cancer," for poster presentation.
  • When compared to gemcitabine and other existing first-line therapies for metastatic pancreatic cancer, Antroquinonol in combination with the standard of care exhibited a significant survival advantage.
  • Antroquinonol in combination with the standard of care may provide patients with significantly improved median overall survival and reduced hematological side-effects.

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024
Fungal infection, Liver, Marketing, Chills, INN, Risk, Leukopenia, Hypotension, Fungus, Hypertension, Nausea, DNA, Inflammation, Liver disease, Anatomy, IIA, CHMP, Diarrhea, Fever, Infection, ATC, Hepatomegaly, European, Neutrophil, Neoplasm, HIV, Tachycardia, Anemia, Hypocalcemia, Hypokalemia, Patient, Medical Subject Headings, Caspofungin, European Commission, Echinocandin, Kidney failure, International, Bilirubin, Neutropenia, Blood, Language, Thrombocytopenia, Magnesium, Select, Medicine, Vomiting, Phlebitis, Amphotericin B, Allergy, Fluconazole, Headache, Rat, Haematopoiesis, Committee, Checklist, Alkaline phosphatase, Rash, Medical device

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 24, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, Platinum, INN, Risk, HER2, Leukopenia, Heartburn, Woman, BRCA, Man, Nausea, DNA, Cancer, Neoplasm, Mutation, Pancreatic cancer, ADP, Prostate, Anatomy, Cell division, Cough, IIA, Diarrhea, Prostate cancer, HRD, Fatigue, Breast cancer, ATC, Platelet, Pancreas, Prednisone, Disease, Genome, Abdomen, Testosterone, PARP, Neutrophil, Bevacizumab, Appetite, Human, Anemia, Patient, Medical Subject Headings, Peritoneum, International, FIGO, Tubing (recreation), Neutropenia, Language, Castration, Dizziness, Thrombocytopenia, BRCA1, Gene, Tablet, Select, Time, Vomiting, Ovary, Prednisolone, X-ray, Ovarian cancer, Headache, BRCA2, European Medicines Agency, Indigestion, Periodic breathing, Birth control

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 24, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Lynparza, olaparib, Date of authorisation: 16/12/2014, Revision: 24, Status: Authorised

Starton Therapeutics Announces Initial Key Safety and Efficacy Signals with STAR-LLD in Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, January 3, 2024
Quality of life, Leukopenia, URTI, Constipation, Lower respiratory tract infection, IND, Insomnia, CD8, Diarrhea, PD-1, DVT, Anemia, Gastroenteritis, Tremor, Fatigue, Common, CD4, Nausea, Multiple myeloma, Neutropenia, Abdominal pain, Therapy, Lenalidomide, Pharmacokinetics, Weakness, Dizziness, Thrombocytopenia, Cytotoxic T cell, Dexamethasone, Appetite, Periodic breathing, Bortezomib, Toxicity, Back pain, Patient, Safety, Peripheral edema, Deep vein thrombosis, Vomiting, Cough, Rash, Bronchitis

Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date. Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks. In comparison, adverse events in these patients observed during a prior regimen containing Revlimid® included nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the more common side effects of lenalidomide (Revlimid®), which include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have been observed with STAR-LLD. Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects. These data suggest that STAR-LLD may prove to be superior in tolerability to oral Revlimid, expanding the number of patients that get the full Revlimid® benefit and improving quality of life.

Key Points: 
  • Patient acceptance of self-administration using the ambulatory pump for lenalidomide delivery has been confirmed in this study.
  • Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date.
  • Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks.
  • Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects.

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

Retrieved on: 
Tuesday, January 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