Peptide | Jotup

COSRX Celebrates the Return of The 6 Peptide Skin Booster Serum - A Derm-Favorite Now Back in Stock at Ulta

Retrieved on:

Friday, February 16, 2024

Cream, Gland, Peptide, Vitamin, Skin, Serum, Hyperpigmentation, Cosmetics

LOS ANGELES, Feb. 16, 2024 /PRNewswire/ -- COSRX, the beloved beauty brand known for its derm-favourite skincare solutions, is delighted to announce the return of the COSRX The 6 Peptide Skin Booster Serum at Ulta.

Key Points:

LOS ANGELES, Feb. 16, 2024 /PRNewswire/ -- COSRX, the beloved beauty brand known for its derm-favourite skincare solutions, is delighted to announce the return of the COSRX The 6 Peptide Skin Booster Serum at Ulta.
The exceptional popularity of The 6 Peptide Skin Booster Serum can be attributed to its unique blend of six peptides which works wonders in addressing various skin concerns, making it the go-to solution for anyone seeking perfect skin.
COSRX recommends incorporating The 6 Peptide Skin Booster Serum as the first step of one's skincare routine.
"We are delighted to bring back The 6 Peptide Skin Booster Serum to Ulta after its remarkable success," said a spokesperson for COSRX.

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
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?

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
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?

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
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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
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?

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
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?

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
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Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on:

Wednesday, February 14, 2024

Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points:

Reflection paper on investigations of pharmacokinetics in
the obese population
Table of contents
1.
References .............................................................................................. 9
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016

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1.
This is considered
a shortcoming that is potentially compounded by obese patients often being poorly represented in
clinical studies.
The specific aims of this reflection paper are to:
?
describe how the effects of obesity can be investigated during clinical medicinal product
development.
?
provide recommendations on when investigations of the effect of obesity on the PK of a
medicinal product should be particularly considered.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
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?

discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
recommendations.
Absorption
Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
and transdermal routes in obese subjects.
Distribution
The distribution of medicinal products is driven by body composition, regional blood flow and binding to
tissue and plasma proteins.
Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
degree of ionization) influence its distribution in the body.
In BMI class III obese
subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
lean subjects (4).
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
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An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
reported in obese individuals.
Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
being proportional to the degree of obesity.
In some cases, in particular for CYP3A4 metabolized medicinal products,
bodyweight normalized clearance can be lower in obese patients (23).
Based on presently available data, it has been suggested that uptake transporters
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016

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are downregulated while efflux transporters may be upregulated (31).
Platelet hyper-reactivity is also observed,
which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 6/12

3.

the medicinal product properties and scientific literature indicate that obesity may lead to a
marked effect on elimination and/or distribution or on the PK/PD relationship.
These
models may aid in extrapolating the known efficacy and safety in the non-obese population to the
obese population.
The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
Before and One Year After Bariatric Surgery.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
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41.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
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The Inn at Rancho Santa Fe Announces The Opening of New Mila Moursi Spa

Retrieved on:

Tuesday, February 13, 2024

RANCHO SANTA FE, Calif., Feb. 13, 2024 /PRNewswire-PRWeb/ -- The Inn at Rancho Santa Fe announces the opening of a new spa in partnership with acclaimed celebrity esthetician Mila Moursi. Representing the first-ever hotel partnership from celebrity-favorite spa owner and luxury skin care line founder, The Mila Moursi Spa at The Inn is now open at the newly reimagined property. With distinctive, state-of-the-art spa offerings and exclusive signature face and body treatments, The Mila Moursi Spa at The Inn sets the stage for relaxation, rejuvenation and results-driven skin care amongst the rolling hills and citrus groves of North County San Diego.

Key Points:

RANCHO SANTA FE, Calif., Feb. 13, 2024 /PRNewswire-PRWeb/ -- The Inn at Rancho Santa Fe announces the opening of a new spa in partnership with acclaimed celebrity esthetician Mila Moursi .
"With her reputation for innovation and an enviable client list of Hollywood's elite, The Mila Moursi Spa at The Inn adds to the allure of our storied property," said Vikram Sood, Managing Director, The Inn at Rancho Santa Fe.
"With her reputation for innovation and an enviable client list of Hollywood's elite, The Mila Moursi Spa at The Inn adds to the allure of our storied property," said Vikram Sood, Managing Director, The Inn at Rancho Santa Fe.
"I am thrilled to bring our state-of-the-art French skin care and innovative techniques to our new Mila Moursi Spa at The Inn," says Mila Moursi, esthetician and founder of The Mila Moursi Skin Care Institute.

BioVaxys Acquires All Intellectual Property, Immunotherapeutics Platform Technology, and Clinical Stage Assets of the Former IMV Inc.

Retrieved on:

Monday, February 12, 2024

Growth, Sale, Ovarian cancer, Protein, Intellectual property, CD8, B cell, Cyclophosphamide, BRCA, APC, Pet, Pfizer, CD4, FRA, Allergy, Vaccine, IMV, Peptide, Limited partnership, Antigen, Patent, Infection, DLBCL, Acquisition, Merck, Livestock, USD, Messenger, DSM-IV codes, Cancer, Platinum, Survivin, Patient, Medicine

HIMV will also be entitled to appoint an observer to BioVaxys's Board of Directors.

Key Points:

HIMV will also be entitled to appoint an observer to BioVaxys's Board of Directors.
The DPX™ antigen delivery platform acquired by BioVaxys is designed to stimulate a specific, coordinated and persistent anti-tumor immune response, improving the lives of patients with solid or hematological cancers.
These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function.
Findings showed clinical benefit to patients with recurrent ovarian cancer, regardless of platinum sensitivity or BRCA mutational status.

BioVaxys Acquires All Intellectual Property, Immunotherapeutics Platform Technology, and Clinical Stage Assets of the Former IMV Inc.

Retrieved on:

Monday, February 12, 2024

HIMV will also be entitled to appoint an observer to BioVaxys's Board of Directors.

Key Points:

HIMV will also be entitled to appoint an observer to BioVaxys's Board of Directors.
The DPX™ antigen delivery platform acquired by BioVaxys is designed to stimulate a specific, coordinated and persistent anti-tumor immune response, improving the lives of patients with solid or hematological cancers.
These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function.
Findings showed clinical benefit to patients with recurrent ovarian cancer, regardless of platinum sensitivity or BRCA mutational status.

Alys Pharmaceuticals launches with $100M financing from Medicxi to advance Immuno-Dermatology focused pipeline

Retrieved on:

Monday, February 12, 2024

BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.

Key Points:

BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.
Originating from the aggregation of six asset-centric Medicxi companies, Alys boasts a robust pipeline of innovative programs and platforms targeting multiple dermatological indications.
The pipeline also includes programs focused on underserved indications such as mastocytosis, cutaneous T-cell lymphoma or prevention of skin side effects of oncology therapies.
Alys combines the assets and platforms of Aldena Therapeutics, Graegis Pharmaceuticals, Granular Therapeutics, Klirna Biotech, Nira Biosciences and Vimela Therapeutics.

Alys Pharmaceuticals launches with $100M financing from Medicxi to advance Immuno-Dermatology focused pipeline

Retrieved on:

Monday, February 12, 2024

BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.

Key Points:

BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.
Originating from the aggregation of six asset-centric Medicxi companies, Alys boasts a robust pipeline of innovative programs and platforms targeting multiple dermatological indications.
The pipeline also includes programs focused on underserved indications such as mastocytosis, cutaneous T-cell lymphoma or prevention of skin side effects of oncology therapies.
Alys combines the assets and platforms of Aldena Therapeutics, Graegis Pharmaceuticals, Granular Therapeutics, Klirna Biotech, Nira Biosciences and Vimela Therapeutics.

Renowned Holistic Plastic Surgeon, Dr. Julius Few, Launches Collection of 'Stackable Skincare' Treatments for Maximum At-Home Results

Retrieved on:

Wednesday, February 7, 2024

Cream, Mineral, Neiman Marcus, Research, Irritation, MD, Elastin, Radical, Ageing, Patient, Collection, Peptide, Skin, Antioxidant, Eye, Very important person, Cosmetics

The brand launches this week at select Neiman Marcus stores across the country and online at NeimanMarcus.com, as well as DrFewSkincare.com.

Key Points:

The brand launches this week at select Neiman Marcus stores across the country and online at NeimanMarcus.com, as well as DrFewSkincare.com.
The launch of his high-performance skincare collection was created following this approach and method combined with cutting-edge innovation to produce natural, long-lasting results at home.
"I've spent years researching how to apply the concept of my patented Stackable Treatments approach to topical skincare to revolutionize skincare routines and maximum at-home results.
The curated collection comprises seven highly-effective skincare formulas that, when stacked together, deliver more effective results than any one formula alone.

Altamira Therapeutics’ Peptide-Based Delivery Platform Shown to Enhance Potency of Commonly Used Gene Delivery Method as Published in Peer-Reviewed Journal

Retrieved on:

Wednesday, February 7, 2024

Vivisection, Peptide, Cell, RNA, Therapy, Alternative medicine, Recombinant, Safety, FDA, Dicarboxylic acid, AVV, Mouse, Food, AAV, Risk, Journal, Tissue, Cytoplasm, Melittin, Vaccine

HAMILTON, BERMUDA, Feb. 7, 2024 -- Altamira Therapeutics Ltd. (Nasdaq: CYTO) ("Altamira" or the "Company"), a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets, announced today the publication of a peer-reviewed article in the Journal of Integrative Medicine titled, "Melittin analog p5RHH enhances recombinant adeno-associated virus transduction efficiency". This work evaluates the use of various peptides to enhance adeno-associated virus (AAV) cell transduction and was conducted by an independent research group.1 Recombinant AAVs are commonly used as carriers to introduce nucleic acids in cells for gene therapy; several AAV-based gene therapy drugs have already been approved by the U.S. Food and Drug Administration (FDA).

Key Points:

The study sought to find ways of increasing the endosomal release of AAV-based therapeutics by using peptides derived from melittin, a component of bee venom known for its ability to permeabilize biological membranes.
The research group evaluated 76 melittin derivatives, including p5RHH, the peptide underlying Altamira’s OligoPhore™ / SemaPhore™ nanoparticle platform for RNA delivery.
The scientists discovered that insertion of p5RHH into the AAV vector (p5RHH-rAAV) not only enhanced cell transduction, but also succeeded in transducing cell lines typically considered resistant to AAVs.
“Better transduction efficiency means that lower doses of AAVs may be used, which could lower the risk for deleterious immune responses and increase the safety of AAV-based vectors.