Itch

Alnylam Announces U.S. Food and Drug Administration Acceptance of Supplemental New Drug Application for OXLUMO® for the Treatment of Advanced Primary Hyperoxaluria Type 1

Retrieved on: 
Tuesday, March 1, 2022
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Risk, Therapy, Type, ESC, Therapeutic index, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pain, Kidney, European Commission, Injection site reaction, Medical Affairs Bureau, Medication, Royal commission, Safety, Itch, Child, Alnylam Pharmaceuticals, Review, Erythema, Swelling, New Drug Application, Food, Adult, PH1, PDUFA, Shanda, European Directive on Traditional Herbal Medicinal Products, FDA, RNA interference, Nasdaq, EMA, Committee for Medicinal Products for Human Use, EVP, Patient, Enhance, GO, Prescription Drug User Fee Act, Milk, Committee, CHMP, Plasma, EGFR, Pregnancy, Profile, Pharmaceutical industry, Medical device, Medicine, Birth control, HAO1, Lumasiran, ILLUMINATE-C Phase 3 Study, Primary Hyperoxaluria Type 1 (PH1), RNAi, Alnylam Pharmaceuticals, LUMASIRAN, ILLUMINATE-C PHASE 3 STUDY, PRIMARY HYPEROXALURIA TYPE 1 (PH1), RNAI, ALNYLAM PHARMACEUTICALS

This filing acceptance is a positive step for patients with advanced PH1, who are at risk for the devastating complications of systemic oxalosis.

Key Points: 
  • This filing acceptance is a positive step for patients with advanced PH1, who are at risk for the devastating complications of systemic oxalosis.
  • OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
  • The most common adverse reaction that occurred in patients treated with OXLUMO was injection site reaction (38%).
  • Lumasiran is a subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) in development for the treatment of advanced primary hyperoxaluria type 1 (PH1).

Kapruvia® receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients

Retrieved on: 
Monday, February 28, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Risk, Canadian International Council, Security (finance), SIX Swiss Exchange, Therapy, Company, Uremic pruritus, Royal commission, Nephrology, Chronic kidney disease, Nasdaq, Private Securities Litigation Reform Act, Health, Outcome (probability), Iron, CKD, Atopic dermatitis, European Medicines Agency, U.S. Securities and Exchange Commission, Review, List of Hindawi academic journals, Itch, Fresenius Medical Care, Multimedia, Dialysis, Veni, vidi, vici, Quality of life, CHMP, MAA, Twitter, European, European Commission, Kidney, International Journal of Nephrology and Renovascular Disease, Vifor Pharma, LinkedIn, Hospital, EMA, Instagram, Patient, Union, Primary biliary cholangitis, Association, FDA, ISIN, Marketing, Mortality, Pharmaceutical industry, Medical device, EU

The CHMP opinion is the basis for the European Commissions final decision regarding marketing authorization for Kapruvia.

Key Points: 
  • The CHMP opinion is the basis for the European Commissions final decision regarding marketing authorization for Kapruvia.
  • If approved, Kapruvia will be the first therapy available in Europe for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients.
  • We are pleased to have received the positive CHMP opinion, which brings us one step closer to making a treatment option available to hemodialysis patients in Europe who suffer from pruritus, said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics.
  • These are major milestones on Cara Therapeutics path to being a category-defining leader in the treatment of pruritus.

CANbridge Announces Approval of CAN108 for Rare Liver Disease, Alagille Syndrome, Under the Early and Pilot Implementation Policy in Boao Lecheng International Medical Tourism Pilot Zone

Retrieved on: 
Friday, February 25, 2022
Biotechnology, General Health, Pharmaceutical, Health, MPS II, IBAT, Policy, Lists of diseases, Disorder, Tuba mirum, Glycogen storage disease, Dysplasia, Liver, MPS, NDA, Research, Incidence, University, National Medical Products Administration, Therapy, Biliary atresia, University of Massachusetts Medical School, Growth, GBM, Haemophilia, Time-invariant system, Liver transplantation, University of Massachusetts, Disease, NMPA, New Drug Application, Degenerative disease, Hunter syndrome, Hepatomegaly, Glioblastoma, Cholestatic pruritus, Quality of life, CEO, Jaundice, Alagille syndrome, LSD, Serum, Fatty liver disease, Excoriation disorder, Kidney, Bile, WuXi Biologics, Patient, Enterohepatic circulation, Liver injury, PFIC, Death, Itch, Ageing, Liver disease, FDA, Sleep deprivation, Pharmaceutical industry, Fine chemical, Alagille Syndrome (ALGS), CAN108 (maralixibat), CANbridge Pharmaceuticals Inc., Biotechnology, General Health, Pharmaceutical, Health, Alagille Syndrome (ALGS), CAN108 (maralixibat), CANbridge Pharmaceuticals Inc., ALAGILLE SYNDROME (ALGS), CAN108 (MARALIXIBAT), CANBRIDGE PHARMACEUTICALS INC.

The Early and Pilot Implementation Policy of Boao Lecheng International Medical Tourism Pilot Zone enables Chinese patients to access therapeutics that are available in other parts of the world, thereby improving the quality of life of patients, especially children.

Key Points: 
  • The Early and Pilot Implementation Policy of Boao Lecheng International Medical Tourism Pilot Zone enables Chinese patients to access therapeutics that are available in other parts of the world, thereby improving the quality of life of patients, especially children.
  • CANbridge has the exclusive license to develop and commercialize CAN108 in Greater China for three rare liver disease indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA).
  • The National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for CAN108 for Alagille syndrome in China under priority review.
  • Alagille syndrome (ALGS) is an autosomal dominant multisystem disorder which can lead to end-stage liver disease and death.

Trevi Therapeutics Reports Statistically Significant Result on Interim Analysis from the Ph2 CANAL Trial of Nalbuphine ER in the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis

Retrieved on: 
Thursday, February 24, 2022
Risk, DEA, News, Death, Webcast, Fast Track, IPF, Itch, SAE, Nalbuphine, Prurigo nodularis, COVID-19, Therapy, Company, Trevi, Clinical trial, United Kingdom, Private Securities Litigation Reform Act, Cough, Safety, Tablet, Exercise, Ph2, FDA, Anxiety, Fatigue, Chronic cough, Patient, Movement disorders, U.S. Securities and Exchange Commission, Idiopathic pulmonary fibrosis, Route of administration, Pharmaceutical industry

Nalbuphine ER has been well-tolerated in the CANAL trial and has been studied in more than 1,000 subjects across indications.

Key Points: 
  • Nalbuphine ER has been well-tolerated in the CANAL trial and has been studied in more than 1,000 subjects across indications.
  • One SAE has been reported in the CANAL trial to date and was not considered to be treatment related.
  • Based on the positive interim analysis for the Ph2 CANAL trial, Trevi has determined to stop further recruitment into the CANAL trial and plans to initiate discussions with Health Authorities regarding the next study.
  • There are no approved therapies for the treatment of chronic cough in IPF, and the cough is often refractory to antitussive therapy.

Cara Therapeutics to Announce Fourth Quarter and Full Year 2021 Financial Results on March 1, 2022

Retrieved on: 
Tuesday, February 22, 2022
GLOBE, News, Twitter, Primary biliary cholangitis, Atopic dermatitis, ID, Therapy, Chronic kidney disease, Company, Itch, LinkedIn, FDA, Nasdaq, Instagram, Patient, Pharmaceutical industry

ET to report fourth quarter and full year 2021 financial results and provide a corporate update.

Key Points: 
  • ET to report fourth quarter and full year 2021 financial results and provide a corporate update.
  • To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 1891805.
  • An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.
  • Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.

Albireo to Report Q4 and Year-End 2021 Financial Results on March 1

Retrieved on: 
Tuesday, February 22, 2022
National Health Service, Boston Business Journal, GLOBE, Institute of Liver and Biliary Sciences, PFIC, OLE, Alagille syndrome, Webcast, Biliary atresia, Media, Event, Company, NICE, Itch, Primary sclerosing cholangitis, Review, Adult, Liver disease, IND, Nasdaq, National Institute for Health and Care Excellence, National Institute, AstraZeneca, Pharmaceutical industry

ET onMarch 1, 2022, to provide a business update and review the companys financial results for the fourth quarter and year ended December 31, 2021.

Key Points: 
  • ET onMarch 1, 2022, to provide a business update and review the companys financial results for the fourth quarter and year ended December 31, 2021.
  • To access the live conference call by phone, dial 877-407-0792(domestic) or 201-689-8263 (international), and provide the access code 13727211.
  • Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden.
  • The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts.

AOBiome Therapeutics' topical biotherapeutic B244 demonstrated positive Phase 2b results from its 547 patient trial for both Pruritus (Itch) and Appearance in its 547 patient Phase 2b trial of Atopic Dermatitis (Eczema)

Retrieved on: 
Tuesday, February 22, 2022
Health, Psoriasis Area and Severity Index, Population, EASI, Inflammation, Itch, Atopic dermatitis, IGA, Therapy, Dermatitis, Vasodilation, Associate, Safety, AOBiome, Health care, Șaeș, Immunomodulation, Patient, History, CEO, Incidence, Pharmaceutical industry, Dermatology

The trial enrolled 547 patients with mild-to-moderate appearance of atopic dermatitis and moderate-to-severe itch.

Key Points: 
  • The trial enrolled 547 patients with mild-to-moderate appearance of atopic dermatitis and moderate-to-severe itch.
  • B244 was well tolerated with no SAEs; treatment related treatment emergent adverse events (TEAEs) were low in incidence, mild in severity, and transient.
  • Additionally, endpoints of Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) for Atopic Dermatitis were captured.
  • Patients with mild to moderate atopic dermatitis can exhibit moderate to severe pruritus which is inadequately addressed by available therapies.

Almirall's Full-Year 2021 Results : Almirall delivers high end of the 2021 upgraded guidance with solid performance from growth drivers

Retrieved on: 
Monday, February 21, 2022
OAB, Prescription, ALM, H1, Cytokine, TCS, OTC, Onychomycosis, Core, Acne, IND, AD, Scalp, Dermatology, Adolescence, Board, European Medicines Agency, Growth, Atopic dermatitis, Safety, Disease, AK, Acceleration, Veni, vidi, vici, General officer, Adherence, Quality of life, Face, AstraZeneca, Population, Week, Water, Tildrakizumab, Advocate, Tetracycline, Sleep, EMA, World Health Organization, Patient, Technology, Science, Income, TRX, Itch, Psoriasis, Annual, Sales, Ageing, MM, Adult, Ciclosporin, Traction, Almirall, AGM, Smith W. Brookhart, EBITDA, Renewable energy, Fine chemical, Rope, Pharmaceutical industry, Vaccine, Holding company, Sarecycline, EU, European, Skin, Tirbanibulin

Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.

Key Points: 
  • Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.
  • Net Salesof 827.2 MM represent a 2.5% year-on-year growth, driven by positive contribution from growth drivers and a strong EU dermatology performance.
  • Core EBITDA*was 211.3 MM, a growth of 16.7%, boosted by strong performance of the growth drivers.
  • Almirall achieved solid operating results, delivering on the upgraded 2021 guidance, as the core business continued to perform well in line with expectations.

Almirall's Full-Year 2021 Results : Almirall delivers high end of the 2021 upgraded guidance with solid performance from growth drivers

Retrieved on: 
Monday, February 21, 2022
OAB, Prescription, ALM, H1, Cytokine, TCS, OTC, Onychomycosis, Core, Acne, IND, AD, Scalp, Dermatology, Adolescence, Board, European Medicines Agency, Growth, Atopic dermatitis, Safety, Disease, AK, Acceleration, Veni, vidi, vici, General officer, Adherence, Quality of life, Face, AstraZeneca, Population, Week, Water, Tildrakizumab, Advocate, Tetracycline, Sleep, EMA, World Health Organization, Patient, Technology, Science, Income, TRX, Itch, Psoriasis, Annual, Sales, Ageing, MM, Adult, Ciclosporin, Traction, Almirall, AGM, Smith W. Brookhart, EBITDA, Renewable energy, Fine chemical, Rope, Pharmaceutical industry, Vaccine, Holding company, Sarecycline, EU, European, Skin, Tirbanibulin

Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.

Key Points: 
  • Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2021 financial results today.
  • Net Salesof 827.2 MM represent a 2.5% year-on-year growth, driven by positive contribution from growth drivers and a strong EU dermatology performance.
  • Core EBITDA*was 211.3 MM, a growth of 16.7%, boosted by strong performance of the growth drivers.
  • Almirall achieved solid operating results, delivering on the upgraded 2021 guidance, as the core business continued to perform well in line with expectations.

Get Cozy Ahead Of National Comfy Day, With Tips From Lifestyle Expert Meredith Staggers

Retrieved on: 
Friday, February 18, 2022
General Health, Fitness & Nutrition, Health, Mental Health, Family, Irritation, Friends, Cake, Melatonin, Sleep, Bacteria, Antioxidant, Love, Itch, Hammer, Confetti, Shoe, Skin, Baking, Cosmetics

In honor of #NationalComfyDay on February 20, its time to break out those cozy sweaters, curl up with a favorite blanket, and make the most of National Comfy Day.

Key Points: 
  • In honor of #NationalComfyDay on February 20, its time to break out those cozy sweaters, curl up with a favorite blanket, and make the most of National Comfy Day.
  • Everyone deserves to be comfy from head-to-toe, especially on a day devoted to comfort, says Meredith Staggers, Founder and Owner of Cake & Confetti .
  • With National Comfy Day falling on a Sunday this year, Im excited to spend the day focused on my own comfort.
  • Below are five tips to consider when planning for National Comfy Day:
    Set the tone.