PN

Summary of opinion: Dupixent, 30/05/2024 Positive

Retrieved on: 
Sonntag, Juni 2, 2024
Patient, Sinusitis, Eosinophilic esophagitis, Atopic dermatitis, Diagnosis, Nitric acid, Marketing, ICS, Medication package insert, Asthma, Dupilumab, Polyp (medicine), LABA, Civil service commission, European Commission, COPD, Chronic obstructive pulmonary disease, Committee, PN, CHMP, Pharmaceutical industry

Summary of opinion: Dupixent, 30/05/2024 Positive

Key Points: 
  • On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.
  • The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.
  • Prurigo Nodularis (PN)
    Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
  • Treatment with Dupixent should be prescribed by a doctor experienced in the diagnosis and treatment of the conditions for which it is indicated.

Summary of opinion: Dupixent, 30/05/2024 Positive

Retrieved on: 
Sonntag, Juni 2, 2024
Patient, Sinusitis, Eosinophilic esophagitis, Atopic dermatitis, Diagnosis, Nitric acid, Marketing, ICS, Medication package insert, Asthma, Dupilumab, Polyp (medicine), LABA, Civil service commission, European Commission, COPD, Chronic obstructive pulmonary disease, Committee, PN, CHMP, Pharmaceutical industry

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.

Key Points: 
  • On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.
  • The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.
  • Prurigo Nodularis (PN)
    Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
  • Treatment with Dupixent should be prescribed by a doctor experienced in the diagnosis and treatment of the conditions for which it is indicated.

Summary of opinion: Dupixent, 30/05/2024 Positive

Retrieved on: 
Sonntag, Juni 2, 2024
Patient, Sinusitis, Eosinophilic esophagitis, Atopic dermatitis, Diagnosis, Nitric acid, Marketing, ICS, Medication package insert, Asthma, Dupilumab, Polyp (medicine), LABA, Civil service commission, European Commission, COPD, Chronic obstructive pulmonary disease, Committee, PN, CHMP, Pharmaceutical industry

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.

Key Points: 
  • On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent.
  • The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.
  • Prurigo Nodularis (PN)
    Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
  • Treatment with Dupixent should be prescribed by a doctor experienced in the diagnosis and treatment of the conditions for which it is indicated.

Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Prurigo Nodularis

Retrieved on: 
Mittwoch, Mai 15, 2024
IGA, Patient, Itch, Survival, Mast cell, Neuroinflammation, Therapy, Disease, Safety, Senior, Neuron, Prurigo nodularis, Injection, Quality of life, B cell, KIT, PN, Pharmaceutical industry

HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN).

Key Points: 
  • HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN).
  • “In our Phase 1b PN study, with just a single dose of barzolvolimab, we demonstrated remarkable clinical results.
  • Participants will then enter a follow-up phase with no study treatment for an additional 16 weeks through week 40.
  • The study will include approximately 50 clinical trial centers worldwide, including the United States.

Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Montag, Mai 6, 2024
AAAAI, Angioedema, Cell, Research, Enrollment, Itch, Atopic dermatitis, Injection, Congress, American Academy, Skin, PN, ILT4, Allergy, KIT, Cold urticaria, Therapy, Omalizumab, Neuropeptide, Patient, UAS7, Survival, PD-1, Rockefeller University, EAACI, Hypersensitivity, Clinical trial, Xeroderma, CSU, G&A, B cell, Prurigo nodularis, Myelocyte, Disease, Inflammation, Eosinophilic esophagitis, Pharmaceutical industry

HAMPTON, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2024 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.
  • Revenues: Total revenue was $0.2 million in the first quarter of 2024, compared to $1.0 million for the comparable period in 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $9.1 million in the first quarter of 2024, compared to $6.6 million for the comparable period in 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2024 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.

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

Retrieved on: 
Freitag, 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: 
Montag, 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: 
Montag, 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: 
Dienstag, Februar 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: 
Montag, Februar 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.