Leukocytosis

Danco Statement on Filing of Cert Petition, September 8, 2023

Retrieved on: 
Friday, September 8, 2023
REMS, Pregnancy, Fifth Circuit Four, Reproductive rights, Bleeding, Allergy, Medication, Diarrhea, Internal bleeding, Pharmacy, Mifepristone, IUD, Gestational age, Misoprostol, Health care, Fever, Danco, Weakness, Woman, Prescription, Angioedema, Prostaglandin, Hypovolemic shock, Patient, Abdominal pain, Sepsis, Rash, Tachycardia, Vomiting, Leukocytosis, Administration, Death, Syncope, Vaginal bleeding, Dizziness, Fungal infection, United States Court of Appeals for the Fifth Circuit, Anaphylaxis, Anemia, Supreme court, Law of the United Kingdom, Nausea, Court, Genetically modified bacteria, FDA, Headache, Hematocrit, Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, Safety, Full, Pharmaceutical industry, Birth control, Vaccine, Dentistry, Nursing, Infection

Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.

Key Points: 
  • Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.
  • The changes in 2016 and 2021—approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.
  • The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.

Danco Statement on 5th Circuit Ruling, August 16, 2023

Retrieved on: 
Thursday, August 17, 2023
REMS, Pregnancy, Reproductive rights, Bleeding, Allergy, Medication, Diarrhea, Internal bleeding, Pharmacy, Mifepristone, IUD, Gestational age, Misoprostol, Health care, Fever, Danco, Weakness, Woman, Prescription, Multimedia, Prostaglandin, Angioedema, Hypovolemic shock, Patient, Abdominal pain, Sepsis, Rash, Tachycardia, Tablet, Vomiting, Leukocytosis, Congress, Death, Administration, Syncope, Vaginal bleeding, Dizziness, United States Court of Appeals for the Fifth Circuit, Fungal infection, Anaphylaxis, Anemia, Supreme court, Nausea, Genetically modified bacteria, FDA, Headache, Hematocrit, Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, Safety, Full, Birth control, Pharmaceutical industry, Vaccine, Dentistry, Nursing, Infection

NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.

Key Points: 
  • NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.
  • Danco remains confident in the safety and effectiveness of Mifeprex® and committed to making the drug available as broadly as possible.
  • Danco will continue to be at the forefront of this fight, working closely with the reproductive rights community and pharmaceutical industry, as this case moves forward.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

SCOTUS Issues Stay

Retrieved on: 
Saturday, April 22, 2023
REMS, Pregnancy, Bleeding, Allergy, Medication, Diarrhea, Internal bleeding, Pharmacy, IUD, Gestational age, Misoprostol, Health care, Fever, Danco, Weakness, Woman, Prescription, Multimedia, Angioedema, Prostaglandin, Hypovolemic shock, Patient, Abdominal pain, Sepsis, Rash, Tachycardia, Vomiting, Leukocytosis, Administration, Death, Literature, Syncope, Vaginal bleeding, Dizziness, Fungal infection, Anaphylaxis, Anemia, Supreme court, Law of the United Kingdom, Nausea, Genetically modified bacteria, FDA, Headache, Hematocrit, Full, Medical device, Pharmaceutical industry, Birth control, Vaccine, Nursing, Infection, Mifepristone

NEW YORK, April 21, 2023 /PRNewswire/ -- We at Danco are gratified the Supreme Court has granted a stay, which keeps the approval of Mifeprex intact without any changes. This stay is an important step in maintaining access to medication abortion during the litigation. Danco stands by the well-established safety profile of Mifeprex and FDA's repeated and careful review of the data and literature in approving the drug and modifying the conditions under which it is available. We remain committed to working with healthcare providers, patients and state and federal governments to keep Mifeprex available and accessible.

Key Points: 
  • This stay is an important step in maintaining access to medication abortion during the litigation.
  • Danco: Gratified the Supreme Court has granted a stay, which keeps the approval of Mifeprex intact without changes.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.

-SCOTUS Issues Administrative Stay-

Retrieved on: 
Saturday, April 15, 2023
Bleeding, IUD, Misoprostol, Prescription, Angioedema, Hypovolemic shock, Patient, April 7, Rash, Syncope, Fungal infection, Court, Federation, REMS, Pregnancy, Allergy, Diarrhea, Internal bleeding, Pharmacy, Gestational age, Weakness, Prostaglandin, Sepsis, Vomiting, Leukocytosis, Administration, Death, Anaphylaxis, Supreme court, Supreme Court of the United States, FDA, Headache, Woman, Health care, Fever, Multimedia, Abdominal pain, Danco Laboratories, Government, Tachycardia, Dizziness, United States Court of Appeals for the Fifth Circuit, Anemia, Law of the United Kingdom, Genetically modified bacteria, Medication, Marketing, United States district court, Vaginal bleeding, Nausea, Hematocrit, Full, Generic drug, Pharmaceutical industry, Birth control, Vaccine, Dentistry, Nursing, Mifepristone, Danco, Infection

NEW YORK, April 14, 2023 /PRNewswire/ -- This afternoon, the US Supreme Court issued an administrative stay of the April 7 order from Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas.  This administrative stay, which runs until midnight on April 19, is a temporary measure that contemplates the Court ruling by then on applications from Danco and the federal government for a broader stay. 

Key Points: 
  • The administrative stay issued today stops Judge Kacsmaryk's order for the time necessary for the Supreme Court to rule on the requests for a full stay.
  • The administrative stay means that the approved status of Mifeprex remains unchanged, including the 2023 revisions to the REMS that allow for dispensing from certified pharmacies and by mail.
  • "It is temporary, but we look forward to the careful consideration we know the Court will give to these important issues.
  • "  Because of the Court's administrative stay, Mifeprex remains approved for use through 70 days' gestation and with the dosing regimen approved in 2016.

Statement In Response To Texas Ruling Upending FDA Approval of Mifeprex®

Retrieved on: 
Saturday, April 8, 2023
Bleeding, IUD, Misoprostol, Public, Food and Drug Administration, Prescription, Angioedema, Hypovolemic shock, Patient, Rash, Science, Syncope, Fungal infection, REMS, Pregnancy, Allergy, Diarrhea, Internal bleeding, Pharmacy, Gestational age, Weakness, Prostaglandin, Sepsis, Vomiting, Leukocytosis, Administration, Death, Anaphylaxis, Supreme court, FDA, Headache, Woman, Reproductive rights, Health care, Fever, Danco, Medicine, Multimedia, Abdominal pain, Danco Laboratories, Tachycardia, Dizziness, United States Court of Appeals for the Fifth Circuit, Anemia, Law of the United Kingdom, Defendant, Genetically modified bacteria, Medication, Vaginal bleeding, Nausea, Hematocrit, Food, Full, Birth control, Vaccine, Dentistry, Nursing, Mifepristone, Infection

 NEW YORK, April 7, 2023 /PRNewswire/ -- Danco Laboratories strongly disagrees with unprecedented preliminary injunction issued by US District Judge Matthew Kacsmaryk in The Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Administration, et al. The lawsuit seeks to overturn FDA's two-plus-decade old approval of Mifeprex and its approval of a generic version of the drug mifepristone. The ruling states that the court is "staying" the 2000 approval of Mifeprex and all subsequent challenged actions related to that approval for the duration of the lawsuit. The ruling is set to take effect in seven days, during which time the Defendants will seek a stay from the US Court of Appeals for the Fifth Circuit. 

Key Points: 
  • The lawsuit seeks to overturn FDA's two-plus-decade old approval of Mifeprex and its approval of a generic version of the drug mifepristone.
  • The ruling states that the court is "staying" the 2000 approval of Mifeprex and all subsequent challenged actions related to that approval for the duration of the lawsuit.
  • Danco is appealing this ruling and feels strongly that the rule of law should prevail in this case, which would result in a reversal of this ruling.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

STATEMENT OF DANCO LABORATORIES REGARDING MIFEPREX®

Retrieved on: 
Friday, March 17, 2023
Bleeding, IUD, Misoprostol, Food and Drug Administration, Prescription, Federal Food, Drug, and Cosmetic Act, Angioedema, Hypovolemic shock, Cosmetic, Patient, Rash, Syncope, Fungal infection, Essential medicines, REMS, Pregnancy, Allergy, Diarrhea, Internal bleeding, Pharmacy, Gestational age, Weakness, Prostaglandin, Sepsis, Vomiting, Leukocytosis, Administration, Death, Anaphylaxis, Hearing, FDA, Headache, Woman, Exercise, Health care, Fever, World Health Organization, Danco, Abdominal pain, Danco Laboratories, Tachycardia, Dizziness, Anemia, Genetically modified bacteria, Medication, Vaginal bleeding, Reading, Nausea, Hematocrit, Food, Full, Pharmaceutical industry, Birth control, Vaccine, Dentistry, Nursing, Mifepristone, Infection

The hearing laid bare both the unprecedented nature of the plaintiffs' legal theory and the speculative nature of their factual allegations.

Key Points: 
  • The hearing laid bare both the unprecedented nature of the plaintiffs' legal theory and the speculative nature of their factual allegations.
  • This too would upend the pharmaceutical industry and has no basis in (and in fact contradicts) the statute, FDA's regulations or case law.
  • The plaintiffs ultimately were forced to admit that they could point to no precedent consistent with their view of the federal statutes at issue.
  • Danco joined this lawsuit in order to ensure that the FDA approval of Mifeprex® remains in force and people continue to have access to this safe and effective product.

Danco Moves to Intervene in Lawsuit Challenging FDA Approval of Mifeprex®

Retrieved on: 
Saturday, January 14, 2023
Nausea, Danco, Mifepristone, Full, Misoprostol, Anemia, Dizziness, Fever, Prostaglandin, Headache, Anaphylaxis, Gestational age, District court, Administration, Syncope, Patient, Bleeding, Vaginal bleeding, Angioedema, FDA, Pregnancy, Weakness, Genetically modified bacteria, Rash, Hematocrit, REMS, Woman, Death, Danco Laboratories, Health care, Internal bleeding, Subclinical infection, Allergy, Douglas v. U.S. District Court ex rel Talk America, Hypovolemic shock, IUD, Sepsis, Medication, Abdominal pain, Prescription, Vomiting, Pharmacy, Leukocytosis, Tachycardia, Diarrhea, Physician, Pharmaceutical industry, Birth control, Vaccine, Dairy product, Medical device, Medicine, Infection

NEW YORK, Jan. 13, 2023 /PRNewswire/ -- Today, Danco Laboratories (Danco) filed a motion to intervene in Alliance for Hippocratic Medicine v. FDA, a lawsuit in which several anti-abortion organizations and four individual physicians asked a federal court to immediately suspend FDA's approval of Mifeprex®.

Key Points: 
  • NEW YORK, Jan. 13, 2023 /PRNewswire/ -- Today, Danco Laboratories (Danco) filed a motion to intervene in Alliance for Hippocratic Medicine v. FDA, a lawsuit in which several anti-abortion organizations and four individual physicians asked a federal court to immediately suspend FDA's approval of Mifeprex®.
  • The lawsuit is also a direct challenge to the FDA approval process for all pharmaceutical products.
  • Danco joins this action to ensure that the FDA approval of Mifeprex® remains in force and people continue to have access to this safe and effective medication.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

Galecto Announces Upcoming Poster Presentation Detailing Results from the Intermediate Assessment of the MYLOX-1 Trial at the 2022 American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Wednesday, December 7, 2022
JAK, Quality of life, Patient, Mortality, Liu v. Securities and Exchange Commission, NSCLC, Security (finance), Poster, Safety, Cancer, Bone marrow, Leukocytosis, Large-cell lung carcinoma, Cirrhosis, LOXL2, IPF, Blood, Primary myelofibrosis, Galecto Biotech, Thrombocytopenia, Collagen, Fibrosis, Disease, Ruxolitinib, Biomarker, Lymphatic system, Anemia, Idiopathic pulmonary fibrosis, Medical imaging, Pharmaceutical industry

BOSTON, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and a world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced that an abstract relating to its ongoing Phase 2 myelofibrosis trial (MYLOX-1) has been accepted for presentation at the 64th American Society of Hematology (ASH) Annual Meeting, taking place in New Orleans, Louisiana and virtually December 10-13, 2022.

Key Points: 

    Optime Care, Specialty Pharmacy Patient Management Organization Announces Enhanced Partnership with Rigel Pharmaceuticals, Inc. for Rezlidhia™ Patients

    Retrieved on: 
    Tuesday, December 13, 2022
    Biotechnology, FDA, Health, Family, Consumer, Other Health, Pharmaceutical, Oncology, Other Science, Research, Managed Care, Genetics, Science, Women, Recurrence, Liver, Hepatotoxicity, Cancer, Uric acid, Mucositis, Disease, Woman, AML, URAC, Hypertension, Potassium, Transaminase, Rash, Sodium, Azacitidine, Partnership, Degenerative disease, Knowledge, HUB, ACHC, Fatigue, Hypotension, Alkaline phosphatase, Clinical trial, Constipation, Fatality, Leukocytosis, Probability, Retinoic acid syndrome, Creatinine, AST, Diarrhea, Jaundice, Postcholecystectomy syndrome, Weight gain, Market access, Dexamethasone, Purging disorder, Edema, Case management (US healthcare system), Mutation, Acute kidney injury, Lymphocyte, Lipase, Disorder, IDH1, CYP3A, Patient, Myelocyte, Nausea, FDA, Hydroxycarbamide, ALT, Breathe Me, Arthralgia, Bilirubin, Accreditation Commission for Health Care, Acute myeloid leukemia, Pharmaceutical industry, Generic drug, Rigel, Fever

    Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, We are excited to work with Optime Care in the complete management of our Rezlidhia patients.

    Key Points: 
    • Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, We are excited to work with Optime Care in the complete management of our Rezlidhia patients.
    • If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.
    • Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA.
    • Our experience with small patient populations, coupled with our strategic partnership with AscellaHealth , enhances our services and ability to serve the specialty pharmacy market.

    GB2064 Shows Reduction in Fibrosis of the Bone Marrow in Patients with Myelofibrosis, Validating LOXL2 as a Clinical Fibrosis Target

    Retrieved on: 
    Thursday, September 29, 2022
    Cirrhosis, IPF, Safety, Fibrosis, Biomarker, NSCLC, Lymphatic system, Idiopathic pulmonary fibrosis, Private Securities Litigation Reform Act, Ruxolitinib, U.S. Securities and Exchange Commission, Patient, Clinical trial, Cancer, Leukocytosis, LOXL2, Quality of life, Bone marrow, JAK, Collagen, Thrombocytopenia, Security (finance), Large-cell lung carcinoma, SEC, Galecto Biotech, Primary myelofibrosis, Blood, Mortality, Disease, Anemia, Medical imaging, Pharmaceutical industry, COVID-19

    The MYLOX-1 clinical trial is an ongoing Phase 2, open-label, single-arm study in myelofibrosis patients who are ineligible, refractory or intolerant to JAK inhibitor therapy.

    Key Points: 
    • The MYLOX-1 clinical trial is an ongoing Phase 2, open-label, single-arm study in myelofibrosis patients who are ineligible, refractory or intolerant to JAK inhibitor therapy.
    • These patients have a progressive disease with poor quality of life, high mortality rates, and very limited treatment options.
    • The primary endpoint of the ongoing MYLOX-1 trial is an assessment of safety and tolerability, while secondary endpoints focus on measurements of bone marrow fibrosis and hematological parameters.
    • In the intermediate assessment, GB2064 demonstrated target engagement and penetration into the fibrotic bone marrow.