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Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on:

Tuesday, March 12, 2024

Filtration, Vespula, Toxicity, Histamine, EAACI, Immunotherapy, Asthma, Report, Allergy, Skin, Pregnancy, PR, EEC, MITES, RNA, Criterion, History, CMR, Contraindication, HEP, Draft, Guideline, Patient, Ames test, Diagnosis, Dermatitis, Venom, Literature, Trial of the century, Reproduction, Silicon–germanium, SPT, Food allergy, Cosmetics, EECS, Absorption, Marketing, Safety, Data collection, Directive 2001/83/EC, GMP, ID50, Antibody, Documentation, European, Type IV hypersensitivity, Genotoxicity, Applicant (sketch), Aeroallergen, CHMP, PRIME, Immunoglobulin G, Type, Publication, Biology, Pollen, DNA, Environment, Immune system, Toolbox, NLN, AIT, Atopic dermatitis, Fatality, Chapter, Anaphylaxis, Process validation, ICH, Antigen, Rhinitis, Clinical trial, Erythema, Knowledge, Prescription, Human, Network, Medication, Scope, VIT, ICT, EMA, Collection, Macrophage, Outline, Metabolism, Registry, Inflammation, Immunoglobulin E, Nature, European Pharmacopoeia, Food, Risk, Prevalence, Mastocytosis, Observation, Cytokine, NPP, Patient safety, Disease, Finished, Medical device

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Key Points:

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Guideline on allergen products development for
immunotherapy and allergy diagnosis in moderate to lowsized study populations

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Table of contents

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Executive summary ..................................................................................... 3

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1.
Specific effects ................................................................................................. 17
14
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Guideline on allergen products development for immunotherapy and allergy diagnosis
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12.
Management for allergies may involve avoidance of the allergen, medications to relieve
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symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.
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Recommendations are made on the clinical development, potential study designs and safety

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considerations for allergen products within the scope of the guideline.
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
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While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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there is no such treatment available for type IV allergies.
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Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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quality and clinical development according to the current knowledge.
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However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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conditions will require separate clinical trials (see Section 6).
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In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

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DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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substantially to the allergen products as discussed above.
1
156

?

Guideline on the clinical development of products for specific immunotherapy for the treatment

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158

of allergic diseases - CHMP/EWP/18504/2006
?

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Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

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Guideline on process validation for finished products - information and data to be provided in
regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

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?

Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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4.
In any
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case, a reduced validation should include all relevant manufacturing process steps that are considered
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product specific.
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Diagnostic allergen products (Type I allergy)

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A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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intracutaneous or provocation testing.
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7.1.
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8.
Clinical development of products for AIT: Study design,
efficacy and safety
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In general, the clinical development should be performed according to current guidelines.
In such single trial, the suitability as a test allergen as well as the
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dose finding for the therapeutic allergen could be investigated.
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8.2.1.
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In general, sensitivity and specificity of the product should be determined.
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10.2.
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4.
Allergol Immunopathol, 1989;
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17(2):53-65

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ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Retrieved on:

Tuesday, March 12, 2024

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The completed comments form should be sent to

Key Points:

The completed comments form should be sent to
[email protected]
*For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
to align with ICH E2D(R1) guideline.
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July 2003
E2D

Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH
regulatory bodies.
12
November 2003
New
Codification
November
2005
E2D

E2D

Revision of E2D
Code

History

E2D(R1) Endorsement by the Members of the ICH Assembly
under Step 2 and release for public consultation.
Date
New
Codification

5 February 2024

E2D(R1)

POST-APPROVAL SAFETY DATA:
DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
E2D(R1)
ICH Consensus Guideline
Table of Contents
1.
The ICH E2D guideline provides guidance on definitions and standards for post-
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approval individual case safety reporting, as well as good case management practices.
Detailed guidance on the
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specific structure, format, standards, and data elements for transmitting Individual Case Safety

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Reports (ICSRs) is provided in the ICH E2B guideline.
Guidance on periodic reporting of
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aggregated safety data is covered in the ICH E2C guideline.
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This guideline provides recommendations that are harmonised to the extent possible given

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differences in post-market safety reporting requirements among ICH regions.
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2.1.2

Adverse Drug Reaction (ADR)

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Adverse drug reactions, as defined by local and regional requirements, concern noxious and

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unintended responses to a medicinal product.
66
Product labelling may include information related to ADRs for the pharmaceutical class to

67

which the medicinal product belongs.
In some cases, ?other observations? can occur
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without any associated AEs/ADRs, while in other cases ?other observations? can occur with

79

an associated AE/ADR.
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For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

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regions refer to AEs.
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Refer to local and regional requirements for specifications and requirements on the reporting

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of AEs or ADRs to each Regulatory Authority.
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2.2

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An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

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point of time.
Cases missing any of the above criteria do not qualify for reporting; due diligence
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should be exercised to collect the missing criteria.
6
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An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

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Other Observations), or both.
Primary sources, often referred
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to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

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to the MAH or regulatory authority.
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2.7

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A digital platform is the software and technology used to enable transmission of information

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between users (see Section 4.3, Digital Platforms).
Expedited Report
Primary Source

Healthcare Professional (HCP)

Consumer

Digital Platform

7

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2.8

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An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

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thereby enabling review to be performed.
MAHs should also follow the
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advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

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287

regulatory authorities.
MAHs may conduct an MRP
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using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

396

selected.
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Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately

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reflected in appropriate ICH E2B data elements.
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Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

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pharmacovigilance data, as duplicates negatively impact signal detection.
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Duplicate detection relies on good quality data and is generally based on similarities but should

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take into account that information in ICSRs may differ between reporters.

Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress

Retrieved on:

Thursday, March 7, 2024

“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points:

“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
This marks the first marketing approval milestone for CSL and Arcturus since signing the Collaboration and License agreement in November 2022.
In November 2023, Arcturus received Orphan Drug Designation from the U.S. FDA for ARCT-032, for the treatment of Cystic Fibrosis.
We have achieved a total of approximately $396.0 million in upfront payments and milestones from CSL as of December 31, 2023.

Xerox Holdings Corporation Announces Pricing of Upsized Convertible Notes Offering

Retrieved on:

Thursday, March 7, 2024

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Xerox Holdings Corporation (NASDAQ: XRX) (the “Company” or “Xerox”) announced today the pricing of $350,000,000 aggregate principal amount of 3.75% Convertible Senior Notes due 2030 (the “Notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Act”).

Key Points:

Xerox Holdings Corporation (NASDAQ: XRX) (the “Company” or “Xerox”) announced today the pricing of $350,000,000 aggregate principal amount of 3.75% Convertible Senior Notes due 2030 (the “Notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Act”).
The size of the offering was increased by $50 million subsequent to the initial announcement of the offering.
The Company also granted the initial purchasers of the Notes a 13-day option to purchase up to $50,000,000 aggregate principal amount of additional notes.
Any tender offer will be made solely pursuant to an offer to purchase to the holders of the 2024 Notes and the 2025 Notes.

Regula Elevates ID Fraud Protection with Enhanced Liveness Checks

Retrieved on:

Thursday, March 7, 2024

View the full release here: https://www.businesswire.com/news/home/20240306499292/en/

Key Points:

View the full release here: https://www.businesswire.com/news/home/20240306499292/en/
Regula Document Reader SDK verifies the authenticity of an ID by checking its optically variable features (Photo: Business Wire)
Responding to this growing need for additional fraud protection, Regula has released an update for its Regula Document Reader SDK , a comprehensive solution for the most reliable and secure identity document verification.
The updated Regula Document Reader SDK can reliably validate the authenticity of an ID by verifying such optically variable features.
With advanced document liveness detection, Regula Document Reader SDK effectively prevents identity fraud and other types of fraud, such as printed photo attacks and screen replay attacks.
That’s why we never stop researching and improving the functionality of Regula Document Reader SDK,” says Ihar Kliashchou, Chief Technology Officer at Regula.

LivaNova Announces Pricing of Private Offering of $300 Million of 2.50% Convertible Senior Notes Due 2029

Retrieved on:

Wednesday, March 6, 2024

Prior to December 15, 2028, the notes will be convertible only upon satisfaction of certain conditions.

Key Points:

Prior to December 15, 2028, the notes will be convertible only upon satisfaction of certain conditions.
If the initial purchasers of the notes exercise their option to purchase additional notes, LivaNova expects to enter into additional capped call transactions with the option counterparties.
The cash exchangeable senior notes were issued by LivaNova USA, Inc. and are guaranteed by LivaNova.
In connection with the issuance of the cash exchangeable senior notes, LivaNova USA, Inc. entered into capped call transactions with certain financial institutions.

SoFi Technologies, Inc. Prices $750 Million Convertible Senior Notes Offering Due 2029

Retrieved on:

Wednesday, March 6, 2024

SoFi Technologies, Inc. (“SoFi”) (NASDAQ: SOFI) today announced that it priced its private offering of 1.25% convertible senior notes due 2029 (the “notes”) in an aggregate principal amount of $750 million.

Key Points:

SoFi Technologies, Inc. (“SoFi”) (NASDAQ: SOFI) today announced that it priced its private offering of 1.25% convertible senior notes due 2029 (the “notes”) in an aggregate principal amount of $750 million.
Following the completion of the offering, SoFi may engage in additional exchanges of, or SoFi may repurchase, its 2026 notes.
These activities may adversely affect the trading price of SoFi’s common stock and the notes SoFi is offering.
Moreover, market activities by holders of the 2026 notes that participate in the exchanges may impact the initial conversion price of the notes SoFi is offering.

Tandem Diabetes Care Prices Upsized Private Placement of $275.0 Million of Convertible Senior Notes Due 2029

Retrieved on:

Wednesday, March 6, 2024

Medical Devices, Health, Diabetes, Health Technology, General Health, Biotechnology, Person, Note, Sale, Exercise, Debt-to-GDP ratio, Tandem Diabetes Care, Risk, Observation, Security (finance)

The offering was upsized from the previously announced offering size of $250.0 million aggregate principal amount of notes.

Key Points:

The offering was upsized from the previously announced offering size of $250.0 million aggregate principal amount of notes.
The sale of the notes is expected to close on March 8, 2024, subject to customary closing conditions.
The notes will mature on March 15, 2029, unless earlier converted, redeemed or repurchased.
The capped call transactions cover, subject to customary adjustments, the number of shares of Tandem’s common stock initially underlying the notes.

Kosmos Energy Ltd. Prices Upsized Offering of $350 Million 3.125% Convertible Senior Notes Due 2030

Retrieved on:

Wednesday, March 6, 2024

Oil, Gas, Energy, Maritime, Transport, Other Energy, Observation, Sale, Exercise, New York Stock Exchange, Person, Security (finance)

Kosmos Energy Ltd. (NYSE/LSE: KOS) (“Kosmos” or the "Company"), announced today that it has priced a private offering of $350 million aggregate principal amount of its 3.125% convertible senior notes due 2030 (the "notes"), which represents a $50 million increase in principal amount from the previously announced offering size.

Key Points:

Kosmos Energy Ltd. (NYSE/LSE: KOS) (“Kosmos” or the "Company"), announced today that it has priced a private offering of $350 million aggregate principal amount of its 3.125% convertible senior notes due 2030 (the "notes"), which represents a $50 million increase in principal amount from the previously announced offering size.
The notes will be senior, unsecured obligations of the Company.
The notes will rank pari passu with the Company’s existing senior notes and the Company’s revolving credit facility.
In the event of certain tax law changes, the Company may redeem the notes in whole, but not in part.

SoFi Technologies, Inc. Announces Proposed Convertible Senior Notes Offering Due 2029

Retrieved on:

Tuesday, March 5, 2024

Professional Services, Other Professional Services, Technology, Software, Finance, Fintech, Banking, Hand, Observation, Sale, Exercise, Debt-to-GDP ratio, Person, SoFi, Note, Security (finance)

The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Key Points:

The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.
Following the completion of the offering, SoFi may engage in additional exchanges of, or SoFi may repurchase, its 2026 notes.
These activities may adversely affect the trading price of SoFi’s common stock and the notes SoFi is offering.
Moreover, market activities by holders of the 2026 notes that participate in the exchanges may impact the initial conversion price of the notes SoFi is offering.