PN

Protara Therapeutics Announces Alignment with FDA on Registrational Path Forward for IV Choline Chloride in Patients Dependent on Parenteral Nutrition

Retrieved on: 
Friday, April 5, 2024
Choline, Plasma, Liver, Nutritional science, Route of administration, Liver disease, Steatosis, Short bowel syndrome, Metabolism, Patient, Choline chloride, Cancer, ESPEN, Parenteral nutrition, Adolescence, Liver injury, Hepatology, Tubing (recreation), Fibrosis, Guideline, Society, Therapy, Copenhagen University Hospital, Safety, Pharmacokinetics, PN, FDA, ASPEN, Rigshospitalet, Food, Feeding tube, Extractive metallurgy

IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.

Key Points: 
  • IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.
  • The Company plans to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PN.
  • The FDA has granted IV Choline Chloride Orphan Drug Designation for the prevention of choline deficiency in PN patients.
  • “We look forward to advancing the clinical development of IV Choline Chloride, which we believe has the potential to become the first FDA approved IV choline therapy for patients dependent on PN.

CMS and Incyte Announce Collaboration and License Agreement for Povorcitinib in China and Southeast Asia

Retrieved on: 
Monday, April 1, 2024
Dermatology, Vitiligo, Prurigo nodularis, Patient, Collaboration, Research, Asthma, JAK1, HS, Hidradenitis suppurativa, PN, CMS, Autoimmunity, Pharmaceutical industry

Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.

Key Points: 
  • Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
  • CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
  • “We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Herve Hoppenot, Chief Executive Officer, Incyte.
  • Upon approval, povorcitinib is poised to synergize with the innovative drugs in the commercialization stage of our pipeline ILUMETRI (tildrakizumab injection), original drugs including Hirudoid (mucopolysaccharide polysulfate cream) and Aethoxysklerol (polidocanol injection) in terms of our network and market resources, which will help the Product to realize its clinical and commercial value.”
    The transaction is effective immediately upon the execution of the Collaboration and License Agreement.

Incyte and CMS Announce Collaboration and License Agreement for Povorcitinib, an Oral JAK1 Inhibitor, in Mainland China, Hong Kong, Macau, Taiwan and Southeast Asia

Retrieved on: 
Monday, April 1, 2024
Research, Biotechnology, Other Health, Health, Cosmetics, Pharmaceutical, Retail, Science, Oncology, Dermatology, Vitiligo, Prurigo nodularis, Patient, Collaboration, Asthma, JAK1, HS, Hidradenitis suppurativa, PN, CMS, Autoimmunity, Pharmaceutical industry

Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.

Key Points: 
  • Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.
  • Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
  • CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
  • “We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Hervé Hoppenot, Chief Executive Officer, Incyte.

Wave Life Sciences Announces Upcoming Presentations at MDA Conference that Highlight Best-in-Class Potential for WVE-N531 in Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, February 27, 2024
B cell, Therapy, Pharmacology, Diaphragm, Chemistry, Dystrophin, DMD, Part, Facial muscles, Duchenne muscular dystrophy, Exon, Conference, Wave, Health, Muscular Dystrophy Association, RNA, PN, Optimism, Protein, Oligonucleotide, RAPS, Half-life, MDA, Episcopal conference, Dietary supplement

CAMBRIDGE, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced its upcoming presentations at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place March 3-6 in Orlando, FL.

Key Points: 
  • Wave’s poster presentations will highlight the best-in-class potential of WVE-N531 in Duchenne muscular dystrophy (DMD), which is currently being evaluated in the Phase 2, potentially registrational FORWARD-53 study.
  • The presentations will also illustrate the impact of Wave’s novel PN chemistry on pharmacology of its exon skipping oligonucleotides.
  • These data suggest that WVE-N531 muscle concentrations in the clinic may be higher in heart and diaphragm than in skeletal muscle.
  • “At Wave, we increasingly continue to regard exon skipping as the preferred mechanism for altering DMD disease progression in those amenable to this approach.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

NorthSea Therapeutics Initiates Phase 2A Trial of Orziloben (NST-6179) in Intestinal Failure-Associated Liver Disease (IFALD)

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Liver, Collagen, Myofibroblast, PD, Liver disease, Cirrhosis, Learning, Short bowel syndrome, Conference, Hepatology, Liver failure, Safety, Steatosis, Rigshospitalet, PN, Therapy, Pharmacokinetics, Cholestasis, Fatty liver disease, Patient, ASPEN, Fibrosis, Disease, NASH, Pharmaceutical industry

The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.

Key Points: 
  • The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.
  • It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Orziloben in adult subjects with IFALD.
  • Commenting on the milestone, Rob de Ree, NST’s CEO, said: "Dosing the first patient in our Phase 2a trial for Orziloben in IFALD is a significant achievement for NorthSea Therapeutics, and is a testament to our commitment to advance innovative treatments for liver diseases.
  • In one pre-clinical model of PN-induced liver injury, Orziloben treatment completely prevented severe cholestasis and the development of fibrosis.

Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023 With Strong Growth Momentum Across All Product Categories

Retrieved on: 
Tuesday, November 21, 2023
Cosmetics, Retail, Health, Technology, Health Technology, Artificial Intelligence, Pharmaceutical, Itch, PIH, Prurigo nodularis, Investment, International Chamber of Commerce, Patient, FACE, R, Growth, IIB, Food, International, Patient satisfaction, Commerce, Calcineurin, Science, Sculptra, Atopic dermatitis, Galderma, Neuromodulation, Adapalene, Botulinum toxin, EBITDA, Adolescence, Risk, ICC, Ivermectin, Partnership, Symantec Endpoint Protection, Ipsen, Skin, PN, Nemolizumab, Liquid Lives, Cryptocurrency, Pharmaceutical industry, Dermatology, Cetaphil

For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.

Key Points: 
  • For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.
  • Internationally, there was particularly strong growth momentum across product categories in fast growing Asian and Latin American markets, including China, India, and Mexico.
  • Based on the strong performance so far, Galderma is on track to deliver at the upper end of its 6-9% net sales constant currency growth range.
  • In Dermatological Skincare, Galderma experienced double-digit net sales growth year-on-year over the first nine months of 2023 on a constant currency basis.

Celldex Therapeutics Presents Positive Data from Prurigo Nodularis Phase 1b Study Demonstrating Meaningful Reduction in Itch and Skin Clearing with Single Dose 3.0 mg/kg Barzolvolimab

Retrieved on: 
Sunday, November 5, 2023
Survival, Patient, KIT, WCI, Social isolation, PN, Itch, Neuron, B cell, Skin, Conference, Sleep, Bleeding, Abstract (summary), CQD, Quality of life, Neuroinflammation, IGA, Prurigo nodularis, Disease, Hives, Depression, Safety, Anxiety, Mast cell, Therapy, Pain, Conference call, Vaccine, Pharmaceutical industry, Dermatology

HAMPTON, N.J., Nov. 05, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from the Company’s Phase 1b study of barzolvolimab in prurigo nodularis (PN). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN. This study is the first to demonstrate that barzolvolimab, a mast cell depleting agent, can potentially be used to treat PN and other chronic itch indications. The data will be presented in an oral presentation during the “Hot Topics” Session at the 12th World Congress on Itch (WCI) 2023 on Tuesday, November 7th by Martin Metz, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin. Abstracts accepted for presentation at the meeting were released today.

Key Points: 
  • - Conference call to be held on Monday, November 6th at 8:00 am ET to discuss study results -
    HAMPTON, N.J., Nov. 05, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from the Company’s Phase 1b study of barzolvolimab in prurigo nodularis (PN).
  • Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN.
  • This study is the first to demonstrate that barzolvolimab, a mast cell depleting agent, can potentially be used to treat PN and other chronic itch indications.
  • The Phase 1b double-blind, single intravenous (IV) dose study randomized 24 adults (evaluable: n=23 safety; n=22 efficacy) with moderate to severe PN across three arms: (1) barzolvolimab 3.0 mg/kg (n=9), barzolvolimab 1.5 mg/kg (n=7) and placebo (n=8).

Celldex Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 2, 2023
CSU, DLQI, Prurigo, Science, Survival, WCI, KIT, Research, Dermatology Life Quality Index, PN, Contingency, Congress, G&A, Work, B cell, PD-1, Cell, R, Quality of life, European Academy of Management, SD, Prurigo nodularis, Myelocyte, Disease, UCT, Eosinophilic esophagitis, Allergy, Georgia World Congress Center, ILT4, Therapy, Patient, Rockefeller University, SCF, Hypersensitivity, D, Pharmaceutical industry, Vaccine, Rare-earth element, Cryptocurrency, Dermatology

HAMPTON, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • - Phase 2 CSU enrollment complete; topline data by YE 2023 -
    HAMPTON, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity.
  • In July 2023, Celldex announced that enrollment to the CSU study (n=208) had been completed and that topline data is anticipated by the end of 2023.
  • Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2023 were $235.3 million compared to $252.7 million as of June 30, 2023.

'Listen to your patients for early identification of Peripheral Neuropathy' say leading Health Experts at P&G's #KNOWTHESIGNS Scientific Forum

Retrieved on: 
Monday, November 6, 2023
Global Medical Device Nomenclature, Patient, Ulcer, Education, PN, Prickle (protein), Neuropathic pain, Neurology, Assistant, Facial muscles, Physician, Prevalence, IDF, Burning Sensations, Health, International Diabetes Federation, DPN, Type 2 diabetes, WDD, Finger, Foot, Hypoesthesia, Senior, AMA, Prediabetes, Paresthesia, Quality of life, Bethesda Hospital, The, Extremities, Risk, P&G, Peripheral neuropathy, Lyceum, Trial of the century, B, Pharmacist, Ankle, Amputation, Diagnosis, Consultant, Infection, Dietary supplement, Pharmaceutical industry, Diabetes

The signature event saw deliberations on the latest clinical guidance on diagnoses and treatment of Peripheral Neuropathy (PN) in Diabetes and Pre-Diabetes.

Key Points: 
  • The signature event saw deliberations on the latest clinical guidance on diagnoses and treatment of Peripheral Neuropathy (PN) in Diabetes and Pre-Diabetes.
  • With Diabetes Mellitus Type 2 being the leading cause of PN, its increasing prevalence is closely linked to the rise in the number of diabetics.
  • B vitamin deficiency and polymedication are other high-risk factors along with diabetes, leading to peripheral nerve damage.
  • Patients should be educated about the importance of regular foot and DPN examinations, glycemic control, and adherence to prescribed medications.