Xeroderma

Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, May 6, 2024
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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.

Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor

Retrieved on: 
Tuesday, April 23, 2024
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BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.

Key Points: 
  • With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.
  • “We are very proud that our first approved medicine addresses this serious and life-threatening disease of childhood and adolescence.
  • BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration.
  • “This is a tremendous moment not only for Day One, but also for the broader pediatric brain tumor community.

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024
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RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Dermatologist Elizabeth Mullans Shares Her Top 5 Skincare Tips to Help Avoid and Relieve Dry Skin this Winter

Retrieved on: 
Tuesday, November 21, 2023
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1. Moisturize generously. Baths, showers, indoor heat, weather changes, and low humidity can all strip away the skin's natural oils, leaving you with dry, chapped, itchy skin. In the winter, I recommend using a gentle moisturizer at least twice a day after cleansing-- in the morning and before bed at night, like CeraVe Moisturizing Cream, Aveeno Eczema Cream, or Eucerin Advanced Repair Cream, to smooth and hydrate the skin, as well as reduce the appearance of blemishes, and plump fine lines and wrinkles.

Key Points: 
  • To help protect against dry skin this winter, and in light of National Healthy Skin Month, Elizabeth Mullans, M.D., board-certified dermatologist and skincare expert at Uptown Dermatology , is sharing her top skincare tips to help maintain healthy skin.
  • “Dry skin can be uncomfortable and even painful, but there are ways to prevent and alleviate this issue.”
    Below, Dr. Mullans shares her top 5 simple steps to help protect against dry skin this winter:
    1.
  • But those with skin sensitivities are more prone to skin damage from scrubbing which can result in dry, irritated skin.
  • “Remember, prevention is key when it comes to maintaining healthy skin all year round, so be proactive with your winter skincare routine,” says Mullans.

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Retrieved on: 
Monday, December 18, 2023
Carboplatin, Vomiting, Cough, Anatomy, Select, ATC, Safety, Radiation, Neutrophil, European Medicines Agency, Rash, MEK, HGG, International, INN, Headache, Language, Tablet, EMA, Patient, IIA, Marketing, Neoplasm, Medical Subject Headings, Diarrhea, Neutropenia, BRAF, Vincristine, Bleeding, Cancer, Nausea, Water, Growth, Fatigue, Xeroderma, LGG, Fever, Mutation, Cell, Instrumentation, Medical imaging, Pharmaceutical industry, Medicinal plants, Medical device, Vaccine, Mobile phone, Online shopping, Bookkeeping, Glioma, Medicine

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Public advisory - Unauthorized health products seized from online retailer "UU Zone" may pose serious health risks

Retrieved on: 
Wednesday, October 25, 2023
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Health Canada is warning consumers about unauthorized health products it seized from UU Zone, an online retailer, based in Markham, ON.

Key Points: 
  • Health Canada is warning consumers about unauthorized health products it seized from UU Zone, an online retailer, based in Markham, ON.
  • The products are labelled to contain medicinal drugs and may pose serious health risks.
  • Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks.
  • Read product labels to verify that health products have been authorized for sale by Health Canada.

The Cosmeceuticals Market to Worth $120.31 Billion by 2028, Nano-Cosmeceuticals to Lead the Future of the Market - Arizton

Retrieved on: 
Tuesday, October 10, 2023
Cosmeceutical, Nanoparticle, Beauty, Unilever, Procter & Gamble, Xeroderma, Gambling, Olay, Skin care, Ageing, Growth, Cosmetics, Developing country, Head, Shoulder, Skin, Nanotechnology, Head & Shoulders, Renewable energy

The US has one of the highest per capita expenditures on cosmetic products and generates substantial revenue from cosmeceuticals.

Key Points: 
  • The US has one of the highest per capita expenditures on cosmetic products and generates substantial revenue from cosmeceuticals.
  • L'Oréal Group is one of the leading market players in the global market.
  • Consumers' increasing use of cosmeceuticals in daily skin & hair care routines drives the demand for innovations in cosmeceuticals.
  • In addition, the application range of nanoparticles in cosmeceuticals widens hair damage care, aging treatments, wrinkles, and skin dryness.