Agency

AF Group Names Middle Market Agency of the Year Winners

Retrieved on: 
Tuesday, April 9, 2024
Partnership, IMA, National accounts, Hub International, Agency, AF Group

LANSING, Mich., April 9, 2024 /PRNewswire/ -- AF Group is proud to recognize two agencies with Middle Market (United Heartland and Third Coast Underwriters) Agency of the Year awards based on their strong premium performance, new business growth and retention during 2023.

Key Points: 
  • LANSING, Mich., April 9, 2024 /PRNewswire/ -- AF Group is proud to recognize two agencies with Middle Market (United Heartland and Third Coast Underwriters) Agency of the Year awards based on their strong premium performance, new business growth and retention during 2023.
  • "IMA and Hub Mid-South have shown tremendous and consistent dedication to providing value to our shared customers," said Michelle McLane, senior vice president of Middle Market and National Accounts for AF Group's Commercial Markets division.
  • "We are so honored and proud to be named United Heartland's Agency of the Year," said Jeff Jamison, Wichita Market president for IMA Financial Group.
  • They represent a commitment to shared values and consistent drive to serve our mutual customers with care," said Justin Bealhen, vice president of Middle Market for AF Group's Commercial Markets division.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

Orphan designation: rovatirelin Treatment of spinocerebellar ataxia, 11/11/2022 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Civil service commission, Spinocerebellar ataxia, Diagnosis, Brain, Prevalence, Disease, BBB, Clinical, Locus coeruleus, Patient, Committee, Thyrotropin-releasing hormone, Spinocerebellar tract, Traffic barrier, EMA, IRIS, Neuron, TRH, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of spinocerebellar ataxia in the European Union on 11 November 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia [...]

Retrieved on: 
Tuesday, April 9, 2024
Community, Civil service commission, Diagnosis, Prevalence, Disease, Patient, Committee, Haemophilia, EMA, IRIS, Human, Agency, European, COMP, Bleeding, Factor VIII, Telephone numbers in Hungary, European Commission, MDC, Marketing, Blood, Liver, Medicine, Pharmaceutical industry

Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia A, 13/04/2022 Positive

Key Points: 


Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia A, 13/04/2022 Positive

Orphan designation: imatinib Treatment of pulmonary arterial hypertension, 21/06/2021 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Enzyme, Prevalence, Cell, Disease, Patient, Committee, Cancer, EMA, IRIS, Imatinib, Orthostatic hypertension, Agency, European, COMP, European Commission, MDC, PAH, Marketing, FGK, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of pulmonary arterial hypertension (PAH) in the European Union on 21 June 2021.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Autologous CD34+ cells transduced with a lentiviral RNA vector that results in integrated cDNA encoding for functional cystinosin Treatment of cystinosis, 19/02/2021 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Prevalence, Cell, Bone marrow, Disease, Novartis, Patient, Committee, RNA, Autotransplantation, EMA, IRIS, Cystinosis, Agency, European, COMP, Blood, European Commission, Marketing, Medicine, Pharmaceutical industry

All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.

Key Points: 
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The medicine, also known as AVR-RD-O4, is a gene therapy, produced from immature blood (stem) cells collected from the patient.
  • After infusion into the patient, these cells permanently settle in the bone marrow, where they multiply to produce mature blood cells.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Olorofim Treatment of invasive Scopulariopsis, 14/01/2022 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Growth, Prevalence, Survival, Disease, Clinical, Patient, Committee, EMA, IRIS, Update, Scopulariopsis, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of invasive Scopulariopsis in the European Union on 14 January 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Adeno-associated virus serotype rh10 containing the human GALC gene Treatment of Krabbe disease, 15/10/2021 Positive

Retrieved on: 
Tuesday, April 9, 2024
Diamond, Community, Diagnosis, Civil service commission, Prevalence, Disease, Patient, Committee, EMA, IRIS, Krabbe disease, GALC, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of Krabbe disease in the European Union on 15 October 2021.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • For more information, see:
    Key facts
    - Active substance
    - Adeno-associated virus serotype rh10 containing the human GALC gene
    - Intended use
    - Treatment of Krabbe disease
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/21/2511
    - Date of designation
    - Sponsor
    Forge Biologics Europe S.L.

Orphan designation: Azithromycin dihydrate Prevention of bronchopulmonary dysplasia, 14/01/2022 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Bronchopulmonary dysplasia, Ureaplasma urealyticum infection, BPD, Prevalence, Protein, Disease, Infection, Clinical, Inflammation, Patient, Committee, Bacteria, EMA, IRIS, Update, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the prevention of bronchopulmonary dysplasia in the European Union on 14 January 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Diamond, Community, MC1R, Civil service commission, Narcolepsy, Diagnosis, Pigment, Erythropoietic protoporphyria, Prevalence, Disease, EPP, Patient, Committee, EMA, IRIS, Agency, European, Skin, COMP, Sponsor, European Commission, Pain, Phototoxicity, PAH, Marketing, Phenylalanine hydroxylase, Medicine, Pharmaceutical industry

Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawn

Key Points: 


Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawn