Erythema

Bestqool Launches Innovative Red Light Therapy Devices for Eczema Relief

Retrieved on: 
Friday, April 5, 2024
Skin care, Fibroblast, Health, Certification, RLT, Psoriasis, Adenosine triphosphate, Cell, Serotonin, Patient, Photobiology, Tissue, Rosacea, Mitochondrion, Mental health, History, Red, Quality of life, Dermatitis, Itch, Keratinocyte, Acne, Skin, Pollution, Erythema, Cytokine, Irritation, ATP, Immune system, Recurrence, Fatigue, Swelling, FDA, Waste, Medical device

Bestqool's advanced red light therapy offers a non-invasive, natural solution for managing this pervasive skin issue.

Key Points: 
  • Bestqool's advanced red light therapy offers a non-invasive, natural solution for managing this pervasive skin issue.
  • Combining red light therapy with topical ointments can be a complementary approach for effective eczema treatment.
  • Bestqool's latest range of portable red light therapy devices are designed to be both convenient and effective for home use.
  • Adding red light therapy to daily care and prevention can repair both inside and outside by lowering eczema recurrence and improving the quality of life.

Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 28, 2024
AstraZeneca, Exercise, Fortification, New Drug Application, Patient, GBM, CRL, NDA, Menkes, Minocycline, Therapy, Marketing, Radiation, CKPT, Rosacea, Investigational New Drug, Erythema, Safety, BLA, Fortress Biotech, Food, Red, Amyloidosis, Dermatology, Carcinoma, FDA, Hyperhidrosis, Mustang Bio, Menkes disease, PDUFA, Pharmaceutical industry

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
  • In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
  • In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
  • Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.

Journey Medical Corporation Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 21, 2024
Research, U.S. FDA, Conference, Growth, Journey, Agreement, FY, IGA, Microbiota, Risk, New Drug Application, Patient, Food and Drug Administration, Rosacea, Hyperhidrosis, NDA, Red, News, Adjustment, Dermatology, Clinical trial, Erythema, Doxycycline, Safety, GAAP, Food, Marketing, FDA, CEA, Total, PDUFA, Pharmaceutical industry

SCOTTSDALE, Ariz., March 21, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the full year ended December 31, 2023.

Key Points: 
  • ET to discuss the financial results and provide a business update
    SCOTTSDALE, Ariz., March 21, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the full year ended December 31, 2023.
  • Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “2023 was a year of growth and development for Journey Medical.
  • In December 2023, Journey Medical entered into a $20.0 million credit facility with SWK Holdings Corporation (“SWK”), a specialized finance company with a focus on the global healthcare sector.
  • In July 2023, Journey Medical announced positive topline results from the two DFD-29 Phase 3 clinical trials (MVOR-1 & MVOR-2) for the treatment of rosacea.

ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Absorption, Human, ARS, MAA, Patent, Caregiver, PD, New Drug Application, SAN, Patient, Adrenaline, Journal, CRL, NDA, American Academy, EMA, Quality of life, Trial of the century, Flare, American College, Investment, Clinical trial, Erythema, Lower respiratory tract infection, Asthma, Body surface area, Itch, Allergy, FDA, AAAAI, Total, Food, Pharmaceutical industry

SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under nasal allergen challenge conditions.
  • R&D Expenses: Research and development expenses were $3.4 million and $20.3 million for the quarter and year ended December 31, 2023, respectively.
  • G&A Expenses: General and administrative expenses were $6.8 million and $47.3 million for the quarter and year ended December 31, 2023, respectively.
  • Net Loss: Net loss was $7.2 million and $54.4 million for the quarter and year ended December 31, 2023, respectively.

Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea

Retrieved on: 
Monday, March 18, 2024
Entrepreneurship, Capsule, Patient, Food and Drug Administration, Rosacea, NDA, Red, Minocycline, Erythema, Food, Marketing, FDA, CEA, Physician, IGA, PDUFA, Pharmaceutical industry

The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024.
  • The Phase 3 clinical trials achieved all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues.
  • DFD-29 demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment (IGA) treatment success as well as the reduction in the total inflammatory lesion count in both studies.
  • For the secondary endpoint evaluating erythema (redness) associated with rosacea, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.”

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Hypersensitivity, Pregnancy, Wart, Head, Congress, Recombinant, Multiple endocrine neoplasia, Dizziness, Safety, Vain, Headache, Bruise, Public, Syncope, Ageing, Merck & Co., Cervical intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal cancer, Virus-like particle, Observation, CIN, Thigh, Human, HPV, Plant, Vaginal intraepithelial neoplasia, Nausea, MRK, VLP, Investment, Immunity, Fever, Erythema, Vaccination, Injury, Vaccine, Allergy, Itch, AIN, Swelling

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Key Points: 
  • Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
  • These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen.

10xBio Announces Data from Interim Analysis of Phase 2b Clinical Trial Showing Superior Efficacy of Novel Drug for Submental Body Contouring

Retrieved on: 
Monday, March 11, 2024
CSFS, PSFS, Biotechnology, Elective surgery, Bruise, Patient, SAN, Abdomen, American Academy, MD, Clinician, Clinical trial, American Academy of Dermatology, Erythema, ITT, FAAD, Pain, AAD, FDA, Organic acid, Edema, Annual general meeting, Pharmaceutical industry

SAN DIEGO, March 11, 2024 /PRNewswire/ -- 10xBio, LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today promising initial clinical trial results on its novel injectable drug for submental body contouring, 10XB101. An innovative alternative to other fat removal options, 10XB101 provides superior efficacy, fewer side effects, enhanced patient tolerability and shorter treatment intervals.

Key Points: 
  • SAN DIEGO, March 11, 2024 /PRNewswire/ -- 10xBio , LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today promising initial clinical trial results on its novel injectable drug for submental body contouring, 10XB101.
  • An innovative alternative to other fat removal options, 10XB101 provides superior efficacy, fewer side effects, enhanced patient tolerability and shorter treatment intervals.
  • "10XB101 has the appropriate product-market fit to capture the tremendous opportunity for submental contouring.
  • In addition, its attributes hold promise for potential expansion to other body contouring applications, such as treatment of the abdomen and flanks."

Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting

Retrieved on: 
Monday, March 11, 2024
American Academy of Dermatology, Microbiota, Marketing, FDA, U.S. FDA, Skin, Forehead, Entrepreneurship, Risk, AAD, Safety, GI, Red, Rosacea, Minocycline, Patient, Clinical trial, Erythema, Vagina, Microbiology, American Academy

SCOTTSDALE, Ariz., March 11, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.

Key Points: 
  • The clinical trial also assessed the safety and tolerability of the treatment.
  • The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical.
  • Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study.
  • Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462 .

ARS Pharmaceuticals announces neffy® meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study

Retrieved on: 
Monday, February 26, 2024
SAN, Incidence, The Study, AAAAI, Caregiver, Angioedema, Histamine, Principal, ARS, FDA, Quality of life, Anaphylaxis, Body surface area, Data, Convention center, Skin, Safety, Joint task force, Allergy, Patient, Flare, Data analysis, CSU, Erythema, Pediatrics, Asthma, Adrenaline, Itch, American Academy, Pharmaceutical industry

Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.

Key Points: 
  • Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.
  • “Urticaria is not only a standalone type I allergy disease, but also represents the most frequent symptom observed during type I allergic reactions including anaphylaxis.
  • neffy may provide episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients.
  • This would follow the anticipated FDA approval of neffy for allergic reactions (Type I) including anaphylaxis in the second half of 2024.