Prevalence

Rhythm Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, February 22, 2024

-- Acquired global rights to oral MC4R agonist LB54640 from LG Chem --

Key Points: 
  • ET --
    BOSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2023.
  • Fourth Quarter and Full Year 2023 Financial Results:
    Cash Position: As of December 31, 2023, cash, cash equivalents and short-term investments were approximately $275.8 million, as compared to $333.3 million as of December 31, 2022.
  • S,G&A Expenses: S,G&A expenses were $32.4 million in the fourth quarter of 2023 and $117.5 million for the year ended December 31, 2023, compared to $26.3 million in the fourth quarter of 2022 and $92.0 million for the year ended December 31, 2022.
  • ET today to review its fourth quarter and year end 2023 financial results and recent business activities.

Rhythm Pharmaceuticals Announces Clinical Development Plan of Setmelanotide for Hypothalamic Obesity in Japan

Retrieved on: 
Thursday, February 22, 2024

BOSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced plans to add a cohort of patients with hypothalamic obesity in Japan to its ongoing global Phase 3 clinical trial of setmelanotide, with dosing expected to begin in the third quarter of 2024.

Key Points: 
  • “Following constructive discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), we are pleased to have developed a clear and efficient plan to support the potential approval of setmelanotide for hypothalamic obesity in Japan,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
  • The condition most frequently follows the growth and surgical removal or other treatment of craniopharyngioma, astrocytoma, or other rare brain tumors.
  • These individuals often experience rapid weight gain, a reduction in energy expenditure, and an increase in hunger leading to severe obesity within six to 12 months following the hypothalamic lesions.
  • Rhythm also announced today that it completed enrollment in the pivotal, 120-patient cohort in its global Phase 3 trial of setmelanotide in hypothalamic obesity with patients, aged 4 years or older with hypothalamic obesity randomized 2:1 to setmelanotide therapy or placebo for a total of 60 weeks, including up to eight weeks for dose titration.

Scilex Holding Company Announces Publication in Anesthesiology Journal of Results from an Investigator-Initiated Research Study Using ZTlido® for the Treatment of Chronic Neck Pain¹

Retrieved on: 
Tuesday, February 20, 2024

PALO ALTO, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced publication in Anesthesiology Journal of results from an investigator-initiated research study using ZTlido® for the treatment of chronic neck pain.

Key Points: 
  • PALO ALTO, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced publication in Anesthesiology Journal of results from an investigator-initiated research study using ZTlido® for the treatment of chronic neck pain.
  • The primary outcome measure was mean reduction in average neck pain coupled with the Patient Global Impression of Change.
  • Neck pain, or cervicalgia, is one of the most common pain presentations in U.S. and the 4th leading cause of disability.
  • According to a 2020 JAMA publication (Journal of the American Medical Association), the U.S. low back and neck pain market is estimated at $134.5B.4

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

Retrieved on: 
Tuesday, March 12, 2024

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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

      19

      1.

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

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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.

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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

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      ?

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

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

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

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
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Axena Health study shows incontinence is a major burden for women in Kenya and Nigeria

Retrieved on: 
Friday, March 8, 2024

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, unveiled the findings from a landmark study to understand the impact of urinary incontinence (UI) on women in sub-Saharan Africa.

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, unveiled the findings from a landmark study to understand the impact of urinary incontinence (UI) on women in sub-Saharan Africa.
  • Through conversations, focus groups and quantitative surveys, women and clinicians expressed a strong desire for education and treatment.
  • Axena Health will conduct a second study in Nigeria to test the feasibility of implementing clinic-based treatment that leverages Leva’s technology.
  • “We believe this is the first large-scale qualitative study to document the significant burden of incontinence among women in Kenya and Nigeria,” said Oliver Muchiri, co-author of the report and Practice Lead, Service and Systems Design Unit at ThinkPlace Kenya.

Global Dental Implants Material, Product, Design & Regional Market Insights & Forecasts 2024-2028 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 8, 2024

The "Global Dental Implants Market (by Material, Product, Design & Region): Insights & Forecast with Potential Impact of COVID-19 (2024-2028)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Dental Implants Market (by Material, Product, Design & Region): Insights & Forecast with Potential Impact of COVID-19 (2024-2028)" report has been added to ResearchAndMarkets.com's offering.
  • The global dental implants market has been segmented on the basis of material, product and design.
  • In terms of the product, the global dental implants market can be divided into endosteal implants, subperiosteal implants, transosteal implants and others.
  • The report provides a comprehensive analysis of the global dental implants market segmented on the basis of material, product, design and region, with potential impact of COVID-19.

Nordic Eyewear Market Insights & Forecasts Report 2024-2028 with Competitive Analysis of Grand Vision, Synsam, Specsavers, Synologen, Optik Team, and Krogh Optikk - ResearchAndMarkets.com

Retrieved on: 
Friday, March 8, 2024

The "Nordic Eyewear Market (Sweden, Denmark, Norway & Finland): Insights & Forecast with Potential Impact of COVID-19 (2024-2028)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Nordic Eyewear Market (Sweden, Denmark, Norway & Finland): Insights & Forecast with Potential Impact of COVID-19 (2024-2028)" report has been added to ResearchAndMarkets.com's offering.
  • The Nordic eyewear market can be categorized into the following sectors Spectacles, Contact Lenses, and Sunglasses.
  • In 2023, the dominant share of Nordic eyewear market was held by Sweden, followed by Denmark, Norway, and Finland.
  • The report provides a comprehensive analysis of the Nordic eyewear market.

Asia-Pacific Organ Transplant Diagnostics Market Report 2024: Analysis and Forecast, 2023-2033 - Market to Grow by $2.2 Billion, Driven by Advancements in Human Leukocyte Antigen (HLA) Typing Tests - ResearchAndMarkets.com

Retrieved on: 
Friday, March 8, 2024

The "Asia-Pacific Organ Transplant Diagnostics Market: Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Asia-Pacific Organ Transplant Diagnostics Market: Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.
  • In 2023, the Asia-Pacific organ transplant diagnostics market was valued at $1.25 billion and is expected to reach $3.45 billion by 2033, with a CAGR of 10.73% during the forecast period 2023-2033.
  • The Asia-Pacific (APAC) organ transplant diagnostics market is experiencing significant growth, propelled by various factors.
  • The key players in the APAC organ transplant diagnostics market analyzed and profiled in the study involve established and emerging players that offer different products and services for organ transplant diagnostics.

Thermo Fisher Scientific Launches CorEvitas Clinical Registry in Generalized Pustular Psoriasis

Retrieved on: 
Friday, March 8, 2024

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).

Key Points: 
  • Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).
  • This registry, which is open to enrollment, is CorEvitas’ 10th syndicated disease registry and addresses an unmet need for real-world evidence (RWE) related to the clinical and patient-reported outcomes of patients with GPP.
  • Thermo Fisher acquired CorEvitas, a leading provider of gold-standard real-world evidence solutions, in August 2023.
  • The registry was launched with clinical guidance from two leading GPP clinical experts who serve as scientific advisors: Dr. Mark Lebwohl, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai; and Dr. Bruce Strober, clinical professor, Department of Dermatology at Yale University.

Asia-Pacific Next-Generation IVD Research Report 2024: Market Size and Growth Potential 2020-2025 and 2026-2033 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 8, 2024

The "Asia-Pacific Next-Generation IVD Market: Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Asia-Pacific Next-Generation IVD Market: Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.
  • The Asia-Pacific (APAC) region is witnessing significant advancements and growth in the Next-Generation In Vitro Diagnostics (IVD) market.
  • The next-generation IVD market has been extensively segmented on the basis of various categories, such as type, end user, and country.
  • The next-generation IVD market has numerous startups paving their way into manufacturing kits, panels, assays, and instruments and entering the market.