Erythema

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
onsdag, april 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), 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 that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS

Retrieved on: 
onsdag, april 17, 2024
Health, FDA, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Pain, American Academy, Phase, ARR, OCR, News, Blood, Swelling, Food, ROG, American Academy of Neurology, Erythema, Inflammation, Roche, Disease, Patient, RMS, Neurology, AAN, EMA, Itch, MRI, PPMS, Irritation, Annual general meeting, Food and Drug Administration, European Medicines Agency, Disability, Pharmaceutical industry

Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation.

Key Points: 
  • Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation.
  • “Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS,” said Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine.
  • “Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity.
  • There are more than 30 ongoing Ocrevus clinical trials designed to help us better understand MS and its progression.

Bestqool Launches Innovative Red Light Therapy Devices for Eczema Relief

Retrieved on: 
fredag, 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: 
torsdag, mars 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: 
torsdag, mars 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: 
torsdag, mars 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: 
måndag, mars 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: 
onsdag, mars 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: 
onsdag, mars 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: 
måndag, mars 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."