Melatonin | Jotup

Orphan designation: melatonin Treatment of perinatal asphyxia, 02/04/2012 Positive

Retrieved on:

Tuesday, April 9, 2024

Overview

Key Points:

Overview
On 2 April 2012, orphan designation (EU/3/12/978) was granted by the European Commission to Dr Nicola J Robertson, United Kingdom, for melatonin for the treatment of perinatal asphyxia.
At the time of orphan designation, there was no treatment for perinatal asphyxia authorised in the EU.
Key facts
- Active substance
- melatonin
- Intended use
- Treatment of perinatal asphyxia
- Orphan designation status
- Positive
- EU designation number
- EU/3/12/978
- Date of designation
- Sponsor
UCL Research Limited
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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:

Corti Set to Disrupt the Health Wearable Market with the First Real-time, Continuous Monitor for Cortisol and Melatonin Hormones, the Key Stress and Sleep Hormones

Retrieved on:

Thursday, April 4, 2024

The wearable features its proprietary passive-sweat sensor technology that non-invasively rests on your skin, day and night, continuously measuring biomarker levels.

Key Points:

The wearable features its proprietary passive-sweat sensor technology that non-invasively rests on your skin, day and night, continuously measuring biomarker levels.
Now, it provides users with unmatched real-time insights into their wellness, establishing a new benchmark for the continuous monitoring of these critical biomarkers.
Corti redefines health monitoring by offering continuous, real-time visibility into the body's key stress and sleep hormones, Cortisol and Melatonin, marking a first in the wearable market.
Moreover, we are actively working with partnering businesses to discover new applications, enhancing its integration into various health and wellness ecosystems.

NaturVet recognized for innovative Scoopables® pet supplement products

Retrieved on:

Monday, March 11, 2024

Editing, Health, Absorption, DHA, MSM, Antioxidant, Nutrient, Relaxation, Pollution, Anxiety, Melatonin, Salmon, Diet, Dog, EPA, Connective tissue, Love, Skin, Immune system, Pet, Allergy, Cat, Multimedia, Dicarboxylic acid, Chondroitin, Parent, Digestion

TEMECULA, Calif., March 11, 2024 /PRNewswire-PRWeb/ -- NaturVet, the 30-year pioneer and present-day innovator of the pet health and wellness industry, has been awarded the Editor's Choice Award from Pet Product News for the Scoopables line. The Scoopables line is a revolutionary supplementing delivery method that derives from the original soft chews pet parents know and love from NaturVet. The supplement line is made with bite-sized versions of the large soft chews, which are irresistibly flavored, perfect for finicky eaters and just as efficacious.

Key Points:

The Scoopables line is a revolutionary supplementing delivery method that derives from the original soft chews pet parents know and love from NaturVet.
The supplement line is made with bite-sized versions of the large soft chews, which are irresistibly flavored, perfect for finicky eaters and just as efficacious.
Click to Tweet: 🐾 @NaturVet's Scoopables vet-formulated soft supplements line was recently recognized with the Editors Choice Award from @PPNIntl.
Hairball Aid: For cats over 12 weeks, this daily supplement with Psyllium Husk and Pumpkin helps eliminate and prevent hairballs.

StimScience Hires Former Fitbit Executive Tim Rosa as Chief Executive Officer to Scale its Somnee Sleep and Neuroscience Wearable Business

Retrieved on:

Wednesday, March 6, 2024

Somnee – the first personalized, smart sleep headband that utilizes non-invasive, closed-loop neurostimulation for longer, higher quality sleep – today announced the appointment of Tim Rosa as its Chief Executive Officer (CEO).

Key Points:

Somnee – the first personalized, smart sleep headband that utilizes non-invasive, closed-loop neurostimulation for longer, higher quality sleep – today announced the appointment of Tim Rosa as its Chief Executive Officer (CEO).
“Wearables have done a great job educating consumers on their general sleep stage trends and insights.
We backed Somnee because the team had every component needed to bring forward clinical-grade consumer technology to change the face of sleep.
As the former Chief Marketing Officer (CMO) at Fitbit, he was pivotal in establishing the connected health and fitness wearables category.

Enveric Biosciences Unveils Library of Preclinical Compounds Across Multiple Distinct Molecule Classes Targeting Mental Health Disorders

Retrieved on:

Wednesday, February 21, 2024

“As a result, Enveric now possesses what we believe to be one of the most diverse portfolios of potential drug molecules for the treatment of key, underserved mental health and neurological disorders.

Key Points:

“As a result, Enveric now possesses what we believe to be one of the most diverse portfolios of potential drug molecules for the treatment of key, underserved mental health and neurological disorders.
Enveric SNDRI compounds also demonstrate distinct additional serotonin receptor binding profiles that bear similarities to those of the antidepressant Nefazodone and the anxiolytic Buspirone.
Enveric NSRI compounds show strong binding to SERT, as well as to the 5-HT1A receptor, known to be a therapeutically valuable target.
For more information about Enveric’s novel preclinical compounds spanning multiple, distinct classes of molecules, please visit: https://www.enveric.com/psybrary .

Lifesum study: Almost three-quarters of Gen Z and Millennials would quit their job tomorrow for one that better supported their well-being

Retrieved on:

Tuesday, February 27, 2024

PayPal, Mental health, Magnesium, Diet, Sleep, Generation Z, Melatonin, Health, Physical fitness, Oura, Amazon, Millennials, Partnership, Nursing

"The report is a wake-up call for employers to grasp the needs of Gen Z and Millennials who are redefining company loyalty by prioritizing personal well-being in career choices.

Key Points:

"The report is a wake-up call for employers to grasp the needs of Gen Z and Millennials who are redefining company loyalty by prioritizing personal well-being in career choices.
The report underscores how a nutrition-first approach can foster long-term well-being, benefiting mental, physical, and emotional health.
Gen Z and Millennials prioritize physical fitness (88%), mental health and stress management (71%), and sleep quality (54%).
The report unveiled the intricate interplay between nutrition and sleep among Gen Z and Millennials.

Seasonal Affective Disorder: Shedding Light on the Winter Blues with AltaPointe Health

Retrieved on:

Tuesday, February 27, 2024

MOBILE, Ala., Feb. 26, 2024 /PRNewswire/ -- As winter settles in and daylight hours diminish, many individuals find themselves grappling with a condition known as Seasonal Affective Disorder (SAD). SAD is a type of depression that typically occurs when exposure to sunlight is limited.

Key Points:

As winter settles in and daylight hours diminish, many individuals find themselves grappling with a condition known as Seasonal Affective Disorder (SAD).
MOBILE, Ala., Feb. 26, 2024 /PRNewswire/ -- As winter settles in and daylight hours diminish, many individuals find themselves grappling with a condition known as Seasonal Affective Disorder (SAD).
"If you have Seasonal Affective Disorder, it can cause you to be depressed up to 40% of the year."
Light therapy, which involves exposure to a bright light that mimics natural sunlight, is a commonly prescribed treatment.

HONOR Introduces the Feature-packed HONOR Pad 9

Retrieved on:

Thursday, February 22, 2024

Certification, Social media, Bluetooth, Connected, RRP, Bass, CPU, Eye, Melatonin, Human, Hertz, Android 13, Android, GPU, Qualcomm, Tablet, Music, RAM, Multi, Software

LONDON, Feb. 22, 2024 /PRNewswire/ -- Global technology brand HONOR today announced the global launch of the HONOR Pad 9, the latest addition to its tablet lineup. Boasting an impressive 12.1-inch 2.5K HONOR FullView Display1 with a 120Hz2 refresh rate, an eight-speaker audio system that incorporates HONOR Histen sound tuning technology, and a powerful Qualcomm® Snapdragon® 6 Gen 1 chipset, the HONOR Pad 9 is a feature-packed tablet that offers exceptional user experience and a distinctive design.

Key Points:

Featuring the HONOR Histen sound tuning technology, the HONOR Pad 9 generates vibrant and dynamic 360° audio, taking any listening experience to new heights.
Powered by the Qualcomm® Snapdragon® 6 Gen 1 Mobile Platform at its core, the HONOR Pad 9 offers exceptional capabilities.
Additionally, the HONOR Pad 9 features the innovative HONOR RAM Turbo (8GB+8GB)11, which leverages a portion of the flash memory as RAM.
The HONOR Pad 9 is also equipped with a high-capacity 8300mAh battery12, providing long-lasting connectivity for users throughout the day.

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on:

Wednesday, February 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 2/14

1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 3/14

plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 4/14

The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 5/14

new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 6/14

?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 7/14

?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 8/14

2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 9/14

?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 10/14

?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 11/14

4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 12/14

?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 14/14

GUNNAR Optiks Partners with tokidoki on New Digital Eye Strain Glasses Collection

Retrieved on:

Wednesday, February 7, 2024

Partnership, Lunar New Year, Melatonin, Headache, GLARE, Collection, Entrepreneurship, Circadian rhythm, Tokidoki, Gunnar Optiks, Translation, Fatigue, Blinking

CARLSBAD, Calif., Feb. 7, 2024 /PRNewswire/ -- GUNNAR Optiks, the preeminent manufacturer and pioneer of premium computer eyewear, today announced the partnership with iconic pop-culture lifestyle brand tokidoki to launch a new collection line of blue light blocking and digital eye strain reduction glasses. The new collections will be focused on classic characters from the tokidoki brand. The first product to launch from the partnership is tokidoki, Year of the Dragon, a limited-quantity collector's edition based on the upcoming Lunar New Year on February 10th.

Key Points:

CARLSBAD, Calif., Feb. 7, 2024 /PRNewswire/ -- GUNNAR Optiks, the preeminent manufacturer and pioneer of premium computer eyewear, today announced the partnership with iconic pop-culture lifestyle brand tokidoki to launch a new collection line of blue light blocking and digital eye strain reduction glasses.
tokidoki, Year of the Dragon, features a unique modified cat-eye shape and single brow line metal construction resulting in an elegant style.
The Vision Council of America estimates that 70% of U.S. adults experience digital eye strain as a result of the increasing use of digital devices.
GUNNAR premium computer eyewear addresses all short and long-term side effects of digital eye strain, including headaches, dry eyes, blurry vision, glare, negative effects of artificial blue light, eye strain, and fatigue.