Concomitant

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

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星期日, 六月 2, 2024
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Key Points: 

    Praxis Precision Medicines to Present on Ulixacaltamide at the American Academy of Neurology 2024 Annual Meeting

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    星期五, 四月 12, 2024

    BOSTON, April 12, 2024 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will deliver presentations of two abstracts showcasing progress of its clinical program evaluating ulixacaltamide for adults with essential tremor (ET) at the American Academy of Neurology (AAN) 2024 Annual Meeting taking place in Denver, Colorado, April 13 – 18, 2024.

    Key Points: 
    • BOSTON, April 12, 2024 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will deliver presentations of two abstracts showcasing progress of its clinical program evaluating ulixacaltamide for adults with essential tremor (ET) at the American Academy of Neurology (AAN) 2024 Annual Meeting taking place in Denver, Colorado, April 13 – 18, 2024.
    • “With Essential3, we’ve developed a decentralized trial program unlike any other in ET, and among the first in the industry,” said Marcio Souza, president and chief executive officer of Praxis.
    • “The experiences of patients with ET are often overlooked so we designed a trial that removes typical obstacles to participation and concentrates on endpoints that truly matter.
    • In our earlier Phase 2 Essential1 study, we observed that patients who were already on propranolol experienced additional benefits when adding ulixacaltamide.

    Ligand Pharmaceuticals Announces New Topiramate Injection Data Presented at 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference

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    星期一, 四月 8, 2024

    The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.

    Key Points: 
    • The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.
    • The authors presented modeling and simulations of IV topiramate dosing based on previous studies conducted by UMN faculty in healthy research participants and patients.
    • Ligand licensed the rights to the IV formulation of topiramate from UMN and entered into a global license agreement with CURx Pharmaceuticals to further develop and commercialize the product.
    • “The availability of an injectable topiramate formulation will make it possible to ensure continuity of therapy.

    CMP Pharma, Inc Announces that Tadliq®, the First and Only FDA-approved Liquid Suspension of Tadalafil, is Now Available

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    星期一, 十月 24, 2022

    FARMVILLE, N.C., Oct. 24, 2022 /PRNewswire/ -- CMP Pharma announced today that Tadliq (Tadalafil) Oral Suspension, 20 mg/5 mL, the first and only FDA-approved oral liquid suspension of tadalafil, is now available.

    Key Points: 
    • FARMVILLE, N.C., Oct. 24, 2022 /PRNewswire/ -- CMP Pharma announced today that Tadliq (Tadalafil) Oral Suspension, 20 mg/5 mL, the first and only FDA-approved oral liquid suspension of tadalafil, is now available.
    • Tadliq is the first and only FDA-approved liquid oral suspension of tadalafil for adult patients with difficulty swallowing.
    • Tadliq has a mildpeppermint flavor and is available in 150 mL bottles with a 24-month shelf life.
    • Support service representatives are available Monday through Friday from 8 AM to 5 PM EST by contacting the program at 1-844-267-0001.

    Rallybio Announces Positive Preliminary Results for RLYB212, an anti-HPA-1a Monoclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia

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    星期三, 九月 28, 2022

    Rallybio Corporation (Nasdaq: RLYB) today announced positive preliminary results from its ongoing Phase 1b proof-of-concept study of RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT).

    Key Points: 
    • Rallybio Corporation (Nasdaq: RLYB) today announced positive preliminary results from its ongoing Phase 1b proof-of-concept study of RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT).
    • These preliminary results continue to support our projected effective target therapeutic concentrations for the prevention of maternal HPA-1a alloimmunization by RLYB212.
    • Consistent with previously reported data, these preliminary results showed acceptable safety and tolerability with no serious adverse events.
    • Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is a potentially life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns.