Pregnancy

Carmell Announces Product Development Completed for G.L.E.E. Launch in March 2024

Retrieved on: 
Monday, February 26, 2024

PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)

Key Points: 
  • PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)
  • product for commercial launch in March 2024.
  • Additionally, the Company is in advanced stages of development and testing of 9 other skincare products anticipated to launch over Spring and Summer 2024.
  • The Carmell skincare product portfolio:
    Carmell G.L.E.E.

Medela Launches Innovative Smart Watch App for New Parents

Retrieved on: 
Thursday, February 22, 2024

Baar, Switzerland, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Medela, the brand trusted by millions of moms*, announced today the global launch of its first-ever Medela Family smart watch app, designed for seamless tracking for Medela breast pumps users.

Key Points: 
  • Baar, Switzerland, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Medela, the brand trusted by millions of moms*, announced today the global launch of its first-ever Medela Family smart watch app, designed for seamless tracking for Medela breast pumps users.
  • The new smart watch app caters to the needs of new parents, offering quick, convenient tracking while on the move.
  • “Medela is committed to supporting mothers and families through innovative solutions, nurturing health for generations,” emphasizes Annette Brüls, CEO of Medela.
  • This app is more than a convenience; it’s a way to stay intimately connected with your baby’s needs, even during the busiest of days.”
    Compatible with both WatchOS® and Wear OS, the Medela Family smart watch app synchronizes automatically with the main smartphone app.

Study: Prenatal COVID exposure associated with changes in newborn brain

Retrieved on: 
Thursday, February 22, 2024

The findings suggest that exposure to the coronavirus and being pregnant during the pandemic could play a role in shaping infant brain development, said Nickie Andescavage, M.D.

Key Points: 
  • The findings suggest that exposure to the coronavirus and being pregnant during the pandemic could play a role in shaping infant brain development, said Nickie Andescavage, M.D.
  • In contrast, an inner area of the brain, known as deep gray matter, was smaller than in unexposed babies.
  • “Their brains formed differently if they were exposed to COVID,” said Dr. Andescavage, adding that “those exposed to COVID had unique signatures” in the brain.
  • But other studies have linked maternal stress and depression to changes in the newborn brain .

Medela Launches Innovative Smart Watch App for New Parents

Retrieved on: 
Thursday, February 22, 2024

Switzerland, Baar, February 22, 2024, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Medela, the brand trusted by millions of moms*, announced today the global launch of its first-ever Medela Family smart watch app, designed for seamless tracking for Medela breast pumps users.

Key Points: 
  • Switzerland, Baar, February 22, 2024, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Medela, the brand trusted by millions of moms*, announced today the global launch of its first-ever Medela Family smart watch app, designed for seamless tracking for Medela breast pumps users.
  • The new smart watch app caters to the needs of new parents, offering quick, convenient tracking while on the move.
  • “Medela is committed to supporting mothers and families through innovative solutions, nurturing health for generations,” emphasizes Annette Brüls, CEO of Medela.
  • This app is more than a convenience; it’s a way to stay intimately connected with your baby’s needs, even during the busiest of days.”
    Compatible with both WatchOS® and Wear OS, the Medela Family smart watch app synchronizes automatically with the main smartphone app.

Evidence review: Maternal mental conditions drive climbing death rate in U.S.

Retrieved on: 
Wednesday, February 21, 2024

“The contribution of mental health conditions to the maternal morbidity and mortality crisis that we have in America is not widely recognized,” said Katherine L. Wisner, M.D.

Key Points: 
  • “The contribution of mental health conditions to the maternal morbidity and mortality crisis that we have in America is not widely recognized,” said Katherine L. Wisner, M.D.
  • , associate chief of Perinatal Mental Health and member of the Center for Prenatal, Neonatal & Maternal Health Research at Children’s National.
  • Overdose and other maternal mental health conditions are taking the lives of more than twice as many women as postpartum hemorrhage, the second leading cause of maternal death.
  • Mental health conditions such as suicide or opioid overdose are to blame for nearly 23% of maternal deaths in America, according to reports from three dozen Maternal Morbidity and Mortality Review Committees, which are state-based organizations that review each maternal death within a year of pregnancy.

Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024

Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Key Points: 


Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

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

Retrieved on: 
Tuesday, March 12, 2024

16

Key Points: 
    • 16

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

      17

      Table of contents

      18

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

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

      Page 2/18

      53

      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

      66

      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

      72

      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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      88

      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

      89

      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

      94

      quality and clinical development according to the current knowledge.

    • 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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      127

      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

      128

      conditions will require separate clinical trials (see Section 6).

    • 129

      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

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

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

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

      157
      158

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

      159
      160
      161

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

      ?

      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

      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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      162

      ?

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

      163

      4.

    • In any

      199

      case, a reduced validation should include all relevant manufacturing process steps that are considered
      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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      200

      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

      291

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

      292

      intracutaneous or provocation testing.

    • 298

      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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      306

      7.1.

    • 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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      377

      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

      378

      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

      376

      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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      415

      dose finding for the therapeutic allergen could be investigated.

    • 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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      454
      455

      8.2.1.

    • 493

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      527

      In general, sensitivity and specificity of the product should be determined.

    • 540

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      561

      10.2.

    • 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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      595

      4.

    • Allergol Immunopathol, 1989;

      602

      17(2):53-65

      603

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

Retrieved on: 
Tuesday, March 12, 2024

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.
    • 18
      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-

      5

      approval individual case safety reporting, as well as good case management practices.

    • Detailed guidance on the

      9

      specific structure, format, standards, and data elements for transmitting Individual Case Safety

      10

      Reports (ICSRs) is provided in the ICH E2B guideline.

    • Guidance on periodic reporting of

      11

      aggregated safety data is covered in the ICH E2C guideline.

    • 12

      This guideline provides recommendations that are harmonised to the extent possible given

      13

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

    • 25

      2.1.2

      Adverse Drug Reaction (ADR)

      26

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

      27

      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

      78

      without any associated AEs/ADRs, while in other cases ?other observations? can occur with

      79

      an associated AE/ADR.

    • 84

      For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

      85

      regions refer to AEs.

    • 86

      Refer to local and regional requirements for specifications and requirements on the reporting

      87

      of AEs or ADRs to each Regulatory Authority.

    • 89

      2.2

      90

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

      91

      point of time.

    • Cases missing any of the above criteria do not qualify for reporting; due diligence

      99

      should be exercised to collect the missing criteria.

    • 6

      104

      An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

      105

      Other Observations), or both.

    • Primary sources, often referred

      112

      to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

      113

      to the MAH or regulatory authority.

    • 127

      2.7

      128

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

      129

      between users (see Section 4.3, Digital Platforms).

    • Expedited Report

      Primary Source

      Healthcare Professional (HCP)

      Consumer

      Digital Platform

      7

      130

      2.8

      131

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

      132

      thereby enabling review to be performed.

    • MAHs should also follow the

      286

      advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

      13

      287

      regulatory authorities.

    • MAHs may conduct an MRP

      395

      using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

      396

      selected.

    • 564

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

      565

      reflected in appropriate ICH E2B data elements.

    • 638

      Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

      639

      pharmacovigilance data, as duplicates negatively impact signal detection.

    • 651

      Duplicate detection relies on good quality data and is generally based on similarities but should

      652

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

QuidelOrtho Receives Health Canada Approval for Quidel® Triage® PLGF Test for Laboratory Use in Canada

Retrieved on: 
Wednesday, March 6, 2024

QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada.
  • The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro® Instrument for the quantitative determination of placental growth factor (“PLGF”) in maternal plasma specimens.
  • With the Triage PLGF test, clinicians can be positioned to better detect angiogenic imbalance and assess the risk for these complications.
  • The Triage PLGF test is available to customers in Canada for use with the Triage MeterPro instrument.

Momcozy Announces Exciting Partnership With Boots

Retrieved on: 
Wednesday, March 6, 2024

Boots, the UK's fastest-growing health and beauty retailer, has announced its partnership with Momcozy, the maker of the ultra-popular M5 Wearable Breast Pump as well as a wide range of maternity care products.

Key Points: 
  • Boots, the UK's fastest-growing health and beauty retailer, has announced its partnership with Momcozy, the maker of the ultra-popular M5 Wearable Breast Pump as well as a wide range of maternity care products.
  • As the industry-leading wearable breast pump manufacturer, Momcozy brings its highly sought-after pumping and nursing bras, lactation massager, and more to Boots' online marketplace, making quality maternity products more accessible throughout the UK.
  • View the full release here: https://www.businesswire.com/news/home/20240306523882/en/
    Momcozy Announces Exciting Partnership With Boots (Photo: Business Wire)
    Momcozy’s first shot to fame was in 2018 with their all-in-one M5 Wearable Breast Pump , which revolutionized pumping by creating a virtually pain-free and discreet way to express anytime, anywhere.
  • Endorsed by 3 million mothers in over 40 countries, Momcozy is a companion to women from pregnancy to early motherhood.