Phototoxicity

Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Diamond, Community, MC1R, Civil service commission, Narcolepsy, Diagnosis, Pigment, Erythropoietic protoporphyria, Prevalence, Disease, EPP, Patient, Committee, EMA, IRIS, Agency, European, Skin, COMP, Sponsor, European Commission, Pain, Phototoxicity, PAH, Marketing, Phenylalanine hydroxylase, Medicine, Pharmaceutical industry

Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawn

Key Points: 


Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase Treatment of phenylalanine hydroxylase deficiency, 16/03/2022 Withdrawn

Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis in adults1

Retrieved on: 
Friday, February 2, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Multimedia, Hypokalemia, Tremor, Mortality, Mycology, Immunodeficiency, Hospice and palliative medicine, Nausea, MHRA, Immune system, UV, Candidiasis, Anemia, Caspofungin, Disease, Wheeze, Patient, Safety, DRC, Abdominal pain, Flushing, Diagnosis, Erythema, Hyponatremia, Rash, Sensation, Royal College of Pathologists, Radiation, Hypotension, Constipation, Risk, Vomiting, Restore, Medication, Phototoxicity, Infection, Medicine, Common, ODD, Diarrhea, Mitt, Pharmaceutical industry

Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2

Key Points: 
  • Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2
    This press release features multimedia.
  • Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash.
  • Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common.
  • Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.2
    Rezafungin may cause increased risk of phototoxicity.

Orphan designation: Dersimelagon Treatment of erythropoietic protoporphyria, 16/03/2022 Positive

Retrieved on: 
Monday, December 18, 2023
Medicine, COMP, Prevalence, Update, European Commission, Trick or Treatment?, Mitsubishi Tanabe Pharma, Phototoxicity, EPP, Disease, Narcolepsy, EMA, Civil service commission, Patient, Agency, European, MC1R, Marketing, Committee, Pigment, Community, Diagnosis, Pain, No Date, No Signature, Erythropoietic protoporphyria, Skin, EURORDIS, Heerdt, Pharmaceutical industry, Medical device, Fine chemical

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of erythropoietic protoporphyria in the European Union on 16 March 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • 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:

In Vitro Toxicology Testing Market Worth $17.1 billion | MarketsandMarkets

Retrieved on: 
Friday, October 27, 2023
MEA, Creative Biolabs, Eurofins Scientific, Pharmacology, Promega, Catalent, Patent, Intertek, Islamic finance products, services and contracts, Food, Charles River Laboratories, LATAM, Toxicology, Genetics, Absorption, Acquisition, Tissue engineering, Maintenance, Research, Protein, Phototoxicity, Software, Metabolism, Drug development, SGS, Growth, Thermo Fisher Scientific, Marketing, Merck Group, Agilent Technologies, Animal, Gene, Corrosion, Safety, Investment, Labcorp, Toxicity, Chemical safety, ADME, Medical device, Pharmaceutical industry, Fine chemical

By product and service, the In vitro toxicology testing market has been further categorized as consumables, assays, equipment, software, and services.

Key Points: 
  • By product and service, the In vitro toxicology testing market has been further categorized as consumables, assays, equipment, software, and services.
  • In 2022, the ADME segment accounted for the largest share of the in vitro toxicology testing market.
  • The pharmaceutical & biopharmaceutical segment accounted for the largest share of the industry segment in the in vitro toxicology testing market in 2022.
  • In 2022, the pharmaceutical & biopharmaceutical industry segment accounted for the largest share of the in vitro toxicology testing market.

In Vitro Toxicology Testing Market Worth $17.1 billion | MarketsandMarkets

Retrieved on: 
Friday, October 27, 2023
MEA, Creative Biolabs, Eurofins Scientific, Pharmacology, Promega, Catalent, Patent, Intertek, Islamic finance products, services and contracts, Food, Charles River Laboratories, LATAM, Toxicology, Genetics, Absorption, Acquisition, Tissue engineering, Maintenance, Research, Protein, Phototoxicity, Software, Metabolism, Drug development, SGS, Growth, Thermo Fisher Scientific, Marketing, Merck Group, Agilent Technologies, Animal, Gene, Corrosion, Safety, Investment, Labcorp, Toxicity, Chemical safety, ADME, Medical device, Pharmaceutical industry, Fine chemical

By product and service, the In vitro toxicology testing market has been further categorized as consumables, assays, equipment, software, and services.

Key Points: 
  • By product and service, the In vitro toxicology testing market has been further categorized as consumables, assays, equipment, software, and services.
  • In 2022, the ADME segment accounted for the largest share of the in vitro toxicology testing market.
  • The pharmaceutical & biopharmaceutical segment accounted for the largest share of the industry segment in the in vitro toxicology testing market in 2022.
  • In 2022, the pharmaceutical & biopharmaceutical industry segment accounted for the largest share of the in vitro toxicology testing market.

Triple Hair Group Reports Positive Results from Safety Studies on its Therapy-07 Prescription Drug

Retrieved on: 
Wednesday, June 14, 2023
Toxicity, Hair loss, US, Hair, Permeability, Phototoxicity, Safety, Pharmaceutical industry, Medical device

MONTRÉAL, June 14, 2023 (GLOBE NEWSWIRE) -- Triple Hair Group Inc. (“Triple Hair” or the “Company”), a company specializing in the development of innovative treatments for alopecia, is pleased to announce that it has received positive results from various preclinical safety studies on its Therapy-07 prescription drug.

Key Points: 
  • MONTRÉAL, June 14, 2023 (GLOBE NEWSWIRE) -- Triple Hair Group Inc. (“Triple Hair” or the “Company”), a company specializing in the development of innovative treatments for alopecia, is pleased to announce that it has received positive results from various preclinical safety studies on its Therapy-07 prescription drug.
  • The studies included acute dermal toxicity, phototoxicity, acute dermal irritation/corrosion and corneal opacity and permeability.
  • The results showed that Therapy-07 respects all known standards in terms of product safety for consumers.
  • “We are very pleased with the results showing that we are in compliance with regulatory authorities regarding the safety of Therapy-07,” said Jean-Philippe Gravel, President and CEO of Triple Hair.

CLINUVEL progresses vitiligo treatment program

Retrieved on: 
Tuesday, May 10, 2022
Linda, Light therapy, JAMA Dermatology, COVID-19, Treatment, Randomness, American Academy of Dermatology, Immune system, Narrowband, Union, GLOBE, EPP, IRB, Peptide, Afamelanotide, Food, Physician, Safety, Patient, Institutional review board, Phototoxicity, Program, ADR, FDA, Adult, Anaphylaxis, Family, US Foods, DNA, History, Skin, Burns, Health, Quality of life, ASX, Erythropoietic protoporphyria, American Academy, Disease, Melanocortin, CUV, DNA repair, Mental health, Melanocyte, Research, Bourke Street, Melbourne, Mazda North American Operations, Pharmaceutical industry, Medical device, Dermatology, Vitiligo

The drug afamelanotide approved by US and European regulators for a rare light intolerance disorder is being evaluated by Australian company CLINUVEL as a treatment for vitiligo patients with darker skin types.

Key Points: 
  • The drug afamelanotide approved by US and European regulators for a rare light intolerance disorder is being evaluated by Australian company CLINUVEL as a treatment for vitiligo patients with darker skin types.
  • Treatment options remain limited, with no treatments for repigmentation of vitiligo currently approved by the US Food and Drug Administration (FDA).
  • Therefore we have chosen to focus on this patient group, with the highest unmet need, as our clinical program progresses, Dr Teng said.
  • Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians.

Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm™

Retrieved on: 
Tuesday, March 22, 2022
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Other Science, Research, Infectious Diseases, Surgery, Science, Clinical Trials, Company, Nonsteroidal anti-inflammatory drug, CTA, NASDAQ, Osteoarthritis, Lists of diseases, Clinical trial, Post-traumatic stress disorder, PK, Physician, PTSD, American Academy of Family Physicians, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Severe acute respiratory syndrome coronavirus 2, U.S. Securities and Exchange Commission, Irritation, Pain management, Pain, Private Securities Litigation Reform Act, Gel, MD, Bupivacaine, Central nervous system, Security (finance), Industry, Chronic pain, Technology, OA, Securities Exchange Act of 1934, CBD, Securities Act of 1933, Knee, American College, COVID-19, Epilepsy, American Academy, American College of Physicians, Anesthesiology, Drug Quality and Security Act, Phototoxicity, MET, Nature, FDA, Family medicine, American College of Radiology, Patient, Toxicity, Pharmaceutical industry, Risk management, IND, EPOLADERM™, VIRPAX PHARMACEUTICALS

Virpax is drafting FDA IND submission documents for Epoladerm that will include these pre-clinical studies.

Key Points: 
  • Virpax is drafting FDA IND submission documents for Epoladerm that will include these pre-clinical studies.
  • Virpax plans to submit the results of the pilot study as part of its IND application.
  • Our internal research and development team, along with an extensive network of partners, has progressed Epoladerm through the IND-enabling studies.
  • We anticipate rapid progress toward the completion of the clinical studies, stated Anthony P. Mack, Chairman and Chief Executive Officer of Virpax.

CLINUVEL Expands Pharmaceutical Portfolio

Retrieved on: 
Monday, November 8, 2021
Maintenance, Hormone, Photoprotection, ADR, CUV, Blood pressure, ACTH, European Commission, CGMP, NASDAQ, LTD, Technology, Appetite, Food, London Bioscience Innovation Centre, Degenerative disease, US Food Sovereignty Alliance, Burns, Bureau of Oceans and International Environmental and Scientific Affairs, Research, Afamelanotide, Phototoxicity, Adrenocorticotropic hormone, EPP, Company, GLOBE, Good manufacturing practice, Metabolism, Development, Light, Anaphylaxis, DNA repair, ASX, TMR, Royal commission, Central nervous system, Biology, Patient, Cell, DNA, Drug development, Erythropoietic protoporphyria, Adult, Pharmaceutical industry, Medical device

MELBOURNE, Australia, Nov. 08, 2021 (GLOBE NEWSWIRE) -- CLINUVEL has expanded its pharmaceutical development portfolio with NEURACTHEL, novel formulations of the melanocortin adrenocorticotropic hormone (ACTH).

Key Points: 
  • MELBOURNE, Australia, Nov. 08, 2021 (GLOBE NEWSWIRE) -- CLINUVEL has expanded its pharmaceutical development portfolio with NEURACTHEL, novel formulations of the melanocortin adrenocorticotropic hormone (ACTH).
  • We also know there are many more underserved patient groups who would benefit from NEURACTHEL treatment, and we will be addressing these unmet medical needs.
  • Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA.
  • SCENESSE , PRNUMBRA , and NEURACTHEL are registered trademarks of CLINUVEL PHARMACEUTICALS LTD.

Willow Biosciences Announces Ground-Breaking Scientific Data for Cannabigerol (CBG) on Human Skin

Retrieved on: 
Tuesday, April 20, 2021
Branches of biology, Medical specialties, Cutaneous conditions, Immunology, Phototoxicity, Toxicology, Keratinocyte, Acne, Anti-inflammatory, Dermal fibroblast, Irritation, Inflammation

"\nWillow CBG demonstrates a robust safety profile, showing no signs of skin irritation, eye irritation or phototoxicity, paving the way for its use in skin care.

Key Points: 
  • "\nWillow CBG demonstrates a robust safety profile, showing no signs of skin irritation, eye irritation or phototoxicity, paving the way for its use in skin care.
  • Based on the safety profile using these in vitro skin models, a Human Repeat Insult Patch Test clinical trial was performed on more than 100 volunteers where Willow CBG was demonstrated to be safe for sensitive skin.
  • Willow\'s activity tests utilizing Normal Human Epidermal Keratinocytes (NHEKs) and Human Dermal Fibroblasts (HDFs), demonstrate that Willow CBG possesses potent anti-inflammatory properties by inhibiting ultraviolet (UV) light and C. acnes-induced pro-inflammatory cytokine release.
  • This data demonstrates the broad anti-inflammatory effect of Willow CBG against these different environmental stressors.