IV

Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, EEA, IV, Civil service commission, Acute leukemia, Fatigue, Astex Pharmaceuticals, European Medicines Agency, Clinical trial, Multimedia, EMA, Induction chemotherapy, AML, Patient, European Economic Area, Physician, EC, European Commission, Nursing, Vaccine, Decitabine, EU

Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.

Key Points: 
  • Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
  • The EC decision applies to the European Economic Area (EEA), which includes the EU member states, Iceland, Liechtenstein and Norway.
  • INAQOVI® is the first and only oral hypomethylating agent licensed in the EEA in this patient population.
  • Safety findings for the fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine1.

The Covery's CEO Announces Personal Investment to Bring Wellness to Hometown Community

Retrieved on: 
Friday, September 22, 2023
The Well Spa, Heart, Sport, Athlete, Sunshine State, Health, IV, Collection, Diving, Pharmaceutical industry, Film industry, Peptide, Coveris

JACKSONVILLE, Fla., Sept. 22, 2023 /PRNewswire/ -- The Covery, a boutique Wellness Spa brand offering a diverse collection of non-invasive therapies that work to strengthen both the mind and body, is thrilled to announce their newest location opening in the Sunshine State. This marks an exciting milestone for both the brand and its CEO, Tatum Crews, who is taking on this endeavor as she doubles down on her commitment with this personal investment of becoming a franchisee. The Covery is thrilled to continue their national expansion efforts and to bring restorative wellness to the Jacksonville area.

Key Points: 
  • This marks an exciting milestone for both the brand and its CEO, Tatum Crews, who is taking on this endeavor as she doubles down on her commitment with this personal investment of becoming a franchisee.
  • The Covery is thrilled to continue their national expansion efforts and to bring restorative wellness to the Jacksonville area.
  • "As the CEO of The Covery Wellness Spa, I am committed to our vision of promoting health and well-being," said The Covery CEO, Tatum Crews.
  • Crews has been in the corporate side of both the health and wellness and franchise industries for over 10 years.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

Retrieved on: 
Friday, September 22, 2023
Priority review, Food and Drug Administration Safety and Innovation Act, Innovation Act, IV, Prevalence, Amputation, Diabetes, QIDP, Methicillin, S. aureus, Methicillin-resistant Staphylococcus aureus, Infection, Act, MRSA, NDA, Fast Track, Osteomyelitis, ABSSSI, GAIN, Diabetic foot infection, Patient, Ulcer, Disease, DFI, Mortality, Toxic shock syndrome, Bacteria, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, Food, Pharmaceutical industry, FDASIA

Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.

Key Points: 
  • Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.
  • Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA).
  • "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations."

NAfME Music Education Policy Roundtable Continues Expansion during Federal Education Appropriations Season

Retrieved on: 
Tuesday, September 19, 2023
Communication, IV, Leadership development, FAME, II, Future, Literature, University of Iowa, Iowa City Community School District, National Association, Culture, National Association for Music Education, Teaching, Policy, Music Publishers Association, Music Construction Set, Organization, Child, Knowledge, El Sistema, Learning, Parent, Curriculum, Public policy, Multimedia, Hip hop music, Composer, Advancement, University, SLAM, Wind, School, Student, Trust, Round Table, OOT, AES, MPA, Nursing, Music, Nightclub, Tutoring, Online shopping, Brain, Education

RESTON, Va., Sept. 19, 2023 /PRNewswire-PRWeb/ -- This summer, the National Association for Music Education (NAfME) welcomed several new members to the Music Education Policy Roundtable (hereafter, the Roundtable), a public policy coalition consisting of more than 80 organizations that advocates for a high-quality music education for all students.

Key Points: 
  • This summer, the National Association for Music Education (NAfME) welcomed several new members to the Music Education Policy Roundtable, a public policy coalition consisting of more than 80 organizations that advocates for a high-quality music education for all students.
  • RESTON, Va., Sept. 19, 2023 /PRNewswire-PRWeb/ -- This summer, the National Association for Music Education (NAfME) welcomed several new members to the Music Education Policy Roundtable (hereafter, the Roundtable), a public policy coalition consisting of more than 80 organizations that advocates for a high-quality music education for all students.
  • The Roundtable believes that music education should be taught by certified music educators, delivering sequential, standards-based music education to all students across the United States.
  • The National Association for Music Education (NAfME) is a collaborative community that supports music educators and advocates for equitable access to music education.

Pulmatrix Announces FDA Acceptance of IND Application for PUR3100 to Treat Acute Migraine

Retrieved on: 
Tuesday, September 19, 2023
Multicenter trial, User experience, IV, Efficacy, Acute, Pharmacokinetics, Sympathetic nervous system, DHE, Randomness, Dihydroergotamine, Evaluation, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry, Tolerability, Safety, Migraine

BEDFORD, Mass., Sept. 19, 2023 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system diseases, today announced the U.S. Food and Drug Administration ("FDA") has accepted the PUR3100 investigational new drug ("IND") application and the Company has received a study may proceed letter for a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Event Study to Evaluate the Safety, Tolerability, and Efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in the Acute Treatment of Migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE via oral inhalation using a dry powder inhaler.

Key Points: 
  • The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE via oral inhalation using a dry powder inhaler.
  • Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix noted, "We are pleased with the PUR3100 IND acceptance and receipt of the study may proceed letter for the Phase 2, proof of concept study.
  • The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE.
  • We are currently pursuing options to advance PUR3100 into a Phase 2 clinical trial to investigate PUR3100 efficacy, safety, tolerability in treating acute migraine subjects."

CS Analytical Expands USP 1207 Container Closure Integrity Testing Programs for IV Bag Systems

Retrieved on: 
Tuesday, September 19, 2023
CCIT, IV, CCI, USP, Flexible, FDA, Micrometre, Industrial design

CLIFTON, N.J., Sept. 19, 2023 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is excited to announce that it had expanded its capabilities to test the ever-challenging IV Bag Container System in accordance with the key concepts of USP 1207 Container Closure Integrity Testing (CCIT) requirements. The CS Analytical CCIT Team has developed new test approaches that enable a method to be effectively developed and validated to a defined micron leak level, while continuing to explore the application of novel technologies and instrumentation for these unique systems.

Key Points: 
  • Taking these challenging package systems head on, the CS Analytical Team has spent almost two years developing alternative test strategies that meet the intent of USP 1207 and provide effective options for clients to consider when working with flexible bag systems.
  • CLIFTON, N.J., Sept. 19, 2023 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is excited to announce that it had expanded its capabilities to test the ever-challenging IV Bag Container System in accordance with the key concepts of USP 1207 Container Closure Integrity Testing (CCIT) requirements.
  • However, with recent regulatory expectations that require a more extensive approach to verifying container closure integrity, highlighted by USP 1207, the ability to effectively test these systems present many unique challenges .
  • Additionally, CS Analytical remains committed to exploring new technologies and applications in support of container closure integrity testing flexible IV bag systems.

20+ Year National Disaster Recovery Veteran Valarie Philipp Joins GrantWorks

Retrieved on: 
Monday, September 18, 2023
State, IV, Senior, Infrastructure, 1994 Northridge earthquake, COVID-19, Philipp, Development aid, Lead, IX, FEMA Public Assistance, Regulation and licensure in engineering, Associate, Welfare, VII, Gold, Esophageal varices, FEMA, Cyclone, Knowledge, III, VI, Airline, Risk management, Engineering

TALLAHASSEE, Fla., Sept. 18, 2023 /PRNewswire-PRWeb/ -- GrantWorks, Inc., a recognized leader of federal and state grant administration and consulting services, is pleased to welcome Valarie Philipp, P.E., as its Vice President of Disaster Recovery Programs. Based in Florida, Philipp will provide strategic guidance and technical expertise to clients nationwide and lead GrantWorks' Federal Emergency Management Agency Public Assistance recovery efforts across the continental U.S., Puerto Rico, and the U.S. Virgin Islands.

Key Points: 
  • Valarie Philipp, P.E., a 20+ year veteran of national FEMA disaster recovery experience, recently joined GrantWorks, Inc. as its Vice President of Disaster Recovery Programs.
  • TALLAHASSEE, Fla., Sept. 18, 2023 /PRNewswire-PRWeb/ -- GrantWorks, Inc., a recognized leader of federal and state grant administration and consulting services, is pleased to welcome Valarie Philipp, P.E., as its Vice President of Disaster Recovery Programs .
  • Based in Florida, Philipp will provide strategic guidance and technical expertise to clients nationwide and lead GrantWorks' Federal Emergency Management Agency Public Assistance recovery efforts across the continental U.S., Puerto Rico, and the U.S. Virgin Islands.
  • Her disaster recovery expertise and passion align perfectly with our company's values and goals," said Bruce Spitzengel, GrantWorks' President and founder.

Smileyscope VR to be Featured at Oracle CloudWorld 2023

Retrieved on: 
Monday, September 18, 2023
Customer success, IV, Anxiety, Medicine, Oracle, LAS, VR, Bear, Patient, Pediatrics, Nursing

LAS VEGAS, Sept. 18, 2023 /PRNewswire-PRWeb/ -- Smileyscope, a pioneering leader in medical virtual reality, is set to be showcased at the prestigious 2023 Oracle CloudWorld event in Las Vegas from September 18th - 21st.

Key Points: 
  • Smileyscope, a pioneering leader in medical virtual reality, is set to be showcased at the prestigious 2023 Oracle CloudWorld event in Las Vegas from September 18th - 21st.
  • LAS VEGAS, Sept. 18, 2023 /PRNewswire-PRWeb/ -- Smileyscope, a pioneering leader in medical virtual reality, is set to be showcased at the prestigious 2023 Oracle CloudWorld event in Las Vegas from September 18th - 21st.
  • Attracting over 40,000 visitors, Oracle CloudWorld is one of the leading tech conferences globally.
  • Smileyscope will be featured in the Customer Success Zone where winners of the Bear Institute PACK (Pediatric Accelerator Challenge for Kids) are highlighted.

argenx Announces Positive CHMP Opinion for Subcutaneous Efgartigimod for Generalized Myasthenia Gravis

Retrieved on: 
Friday, September 15, 2023
1991 World Sportscar Championship, IV, Marketing, SC, GMG, European Medicines Agency, Committee for Medicinal Products for Human Use, Quality of life, Committee, EMA, Euronext, Patient, Physician, ADAPT, Autoimmune disease, Ghent University, Immunoglobulin G, SE, Acetylcholine receptor, Ghent University Hospital, EC, CHMP, Pharmaceutical industry, Vaccine

SC efgartigimod is formulated with Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.

Key Points: 
  • SC efgartigimod is formulated with Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.
  • “Generalized myasthenia gravis is a complex and devastating disease that is debilitating for people who live with it, making routine movements exhausting and challenging to perform,” said Prof. dr. Jan De Bleecker, Ghent University Hospital and Ghent University.
  • The positive CHMP opinion is a scientific recommendation for marketing authorization, serving as a basis for the EC’s final decision on argenx’s application for SC efgartigimod.
  • The decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein.

AlveoGene Launches to Develop Unique Inhaled Gene Therapies for Rare Respiratory Disorders

Retrieved on: 
Thursday, September 14, 2023
Department of Health and Social Care, Infection, OCC, Social work, Idiopathic pulmonary fibrosis, US Foods, Partnership, Cystic Fibrosis Trust, University, Emphysema, IV, Trust, DSM-IV codes, Medical Research Council, Wellcome Trust, Respiratory disease, University Hospitals Cleveland Medical Center, Department of Engineering Science, University of Oxford, Cystic fibrosis, Inflammation, Oxford Sciences Enterprises, GTC, CFTR, AATD, MD, Patient, Diagnosis, OSE, Imperial College London, Pharmaceutical industry, Management, Medical device, Grifols, Circassia

AlveoGene has been created by OSE, Harrington and OCC in partnership with six leading scientists from the world-renowned UK Respiratory Gene Therapy Consortium (GTC).

Key Points: 
  • AlveoGene has been created by OSE, Harrington and OCC in partnership with six leading scientists from the world-renowned UK Respiratory Gene Therapy Consortium (GTC).
  • AlveoGene will also evaluate the potential of the InGenuiTy™ platform alongside other technologies to create a pipeline of novel inhaled gene therapies targeting other rare respiratory disease opportunities, such as lung surfactant deficiencies and idiopathic pulmonary fibrosis.
  • This will enable AlveoGene to rapidly advance our first candidate – AVG-001 a unique, inhaled gene therapy for AATD – towards clinical development.
  • AlveoGene is the culmination of a successful collaboration between leading researchers from top-ranked UK universities, via GTC, and we believe the company has the potential to become a leader in respiratory gene therapy.