Erythema

LianBio Completes Enrollment in Pivotal Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis

Retrieved on: 
Thursday, June 8, 2023
Eyelash, LIBRA, Quality of life, Inflammation, Erythema, Patient, Blepharitis, MITES, Safety, Disease, Pharmaceutical industry, Demodex

SHANGHAI, China and PRINCETON, N.J., June 08, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the completion of enrollment in the Phase 3 LIBRA clinical trial of TP-03 in Chinese patients with Demodex blepharitis.

Key Points: 
  • “LianBio is committed to bringing a safe and effective treatment option to the tens of millions of patients living with Demodex blepharitis in China,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio.
  • “Although patients with Demodex blepharitis experience significant impact to quality of life, today there are no available treatments that address the underlying cause of their disease.
  • LIBRA is a Phase 3 multicenter, double-blind, randomized, vehicle-controlled registrational study designed to evaluate the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis, with an open-label pharmacokinetics sub-study.
  • LianBio expects to report topline results from the LIBRA trial in the fourth quarter of 2023.

Sirnaomics Reports Interim Results of STP705 Phase I Clinical Study for Medical Aesthetics Treatment in Adults Undergoing Abdominoplasty

Retrieved on: 
Monday, June 5, 2023
Histology, Safety, Incidence, Division, Kruskal–Wallis one-way analysis of variance, Carcinoma, Dunn, Observation, RNA interference, LSR, University, Diet, Therapy, Genetics, Ageing, Abdominoplasty, Behzad Razavi, Plastic, Fat necrosis, FDA, BCC, Skin, Exercise, Injection, Interim, Bruise, Erythema, Research, Panniculitis, Edema, Clinical trial, RNA, Trial of the century, Causality, Abdomen, Pharmaceutical industry, Dietary supplement

The initial results of the Phase I trial appear to indicate that the use of STP705 in the treatment of unwanted fat is safe and show clear signs of efficacy.

Key Points: 
  • The initial results of the Phase I trial appear to indicate that the use of STP705 in the treatment of unwanted fat is safe and show clear signs of efficacy.
  • This interim efficacy results examined efficacy data from six participants that were scheduled to undergo abdominoplasty.
  • The positive interim results have better informed the Group about the later stage development of STP705 in the medical aesthetics category.
  • "The interim results of this Phase I clinical study have brought a strong enthusiasm using RNAi drug for medical aesthetic treatment.

FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

Retrieved on: 
Monday, May 22, 2023
Blood pressure, Priority review, Restless, Goose, Nasal cavity, Emergency, Drug overdose, Hyperhidrosis, Diarrhea, Hypotension, Anxiety, Fever, Yawn, Weakness, Appetite, Shivering, Tachycardia, Pain, Vomiting, Nose, Death, Dizziness, Chronic pain, Erythema, Patient, Throat irritation, Hypoventilation, Perspiration, Nausea, Sneeze, Drug, Diagnosis, Nervous, FDA, Headache, Nasal congestion, Tremor, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Irritability, Food, Safety, Fatigue, Pharmaceutical industry, Medical device

SILVER SPRING, Md., May 22, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.

Key Points: 
  • This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.
  • "The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products," said FDA Commissioner Robert M. Califf, M.D.
  • "On the heels of the FDA's recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders."
  • If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (i.e., hypotension).

scPharmaceuticals Inc. Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, May 10, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, Medicaid, Hypoproteinemia, Organic acid, Heart failure, AT, Urine, Pharmacy, Creatinine, Cirrhosis, Dehydration, Tinnitus, Glucose, Heart, Deafness, Huber loss, Edema, Food and Drug Administration, Hepatic encephalopathy, Medicare Part D, Prescription, Research, Part, Oliguria, History, Trial of the century, Diuresis, Uric acid, Medicare, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Investment, Physician, Patient, Urinary retention, Azotemia, Ascites, Coma, Blood volume, Benign prostatic hyperplasia, Therapy, Thrombosis, Cerebral edema, BUN, CO2, Conference, Food, Anuria, Security (finance), Pharmaceutical industry, Health insurance, Video game, Medical device, BURLINGTON

BURLINGTON, Mass., May 10, 2023 (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 first quarter ended March 31, 2023, and provided a business update. 

Key Points: 
  • Ended the first quarter of 2023 with cash, cash equivalents and short-term investments of $116.1 million.
  • Net product revenues were $2.1 million and cost of product revenues were $0.6 million for the first quarter of 2023.
  • Research and development expenses were $2.1 million for the first quarter of 2023, compared to $4.3 million for the first quarter of 2022.
  • As of March 31, 2023, scPharmaceuticals’ total shares outstanding was 35,769,073.
    scPharmaceuticals’ management will host a conference call and webcast to review the Company’s first quarter 2023 results today, Wednesday, May 10, at 4:30 p.m.

Merus Announces Publication of an Abstract on Petosemtamab in Advanced Gastric/Esophageal Adenocarcinoma for Presentation at the AACR Annual Meeting 2023

Retrieved on: 
Friday, April 14, 2023
GEA, AACR, Diarrhea, Hypotension, Aes, Meru, Hazaribagh, American Association for Cancer Research, LGR5, Head, IRR, CNA, Neck, Rash, Erythema, Patient, Causality, Immunoglobulin G, EGFR, Nausea, Periodic breathing, Vaccine, Pharmaceutical industry, IHC

Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial in advanced solid tumors, including advanced GEA.

Key Points: 
  • Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial in advanced solid tumors, including advanced GEA.
  • Although petosemtamab has demonstrated promising clinical activity among pretreated gastric/esophageal adenocarcinoma (GEA) patients having EGFR gene amplification and/or overexpression, the Company has decided to pause further clinical exploration of the GEA cancer cohort at this time.
  • The Company plans to prioritize investigating petosemtamab in head and neck squamous cell carcinoma, in view of the strong clinical activity observed in this cohort.
  • Title: MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced gastric/esophageal adenocarcinoma (GEA)

Merus Announces Publication of an Abstract on Petosemtamab Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma for Plenary Session Oral Presentation at the AACR Annual Meeting 2023 and Provides a Program and Regulatory Update

Retrieved on: 
Friday, April 14, 2023
AACR, Food and Drug Administration, Diarrhea, Hypotension, Principal investigator, Overalls, Survival, Aes, Clinical trial, American Association for Cancer Research, UC San Diego Health, LGR5, Head, IRR, Neck, Cetuximab, Rash, Erythema, Patient, UC, Causality, EGFR, Immunoglobulin G, Webcast, Nausea, Periodic breathing, Moores Cancer Center, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PD-L1, Food, Safety, Pharmaceutical industry, Medical device, Vaccine, Palladium, Meru Networks, HNSCC, Pembrolizumab

ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., April 14, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced the publication of an abstract for a plenary session oral presentation of interim clinical data on the bispecific antibody petosemtamab in previously treated head and neck squamous cell carcinoma (HNSCC) at the American Association for Cancer Research (AACR) Annual Meeting 2023 taking place in Orlando, Florida April 14-19, 2023.

Key Points: 
  • ”We are excited by these data demonstrating clinically meaningful efficacy and durability of petosemtamab in previously treated head and neck cancer.
  • We are looking forward to sharing additional details at the AACR clinical trials plenary session and on our upcoming investor call,” said Dr. Andrew Joe, Chief Medical Officer at Merus.
  • The Company also initiated a cohort investigating petosemtamab in combination with Keytruda in patients with untreated HNSCC, designed to evaluate safety and clinical activity in this population.
  • The Company plans to continue to acquire data to confirm a suitable dose for future randomized clinical trials.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 22, 2023
Hypersensitivity, Furosemide, Oaktree Capital Management, NYHA, Congestion, Embolism, Hypoproteinemia, Organic acid, Heart failure, AT, Urine, Marketing, Creatinine, Cirrhosis, Dehydration, Tinnitus, Heart, Glucose, Huber loss, Deafness, Edema, Hepatic encephalopathy, Medicare Part D, Research, Oliguria, History, Diuresis, Uric acid, Medicare, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Patient, Investment, Urinary retention, Azotemia, Ascites, Coma, Blood volume, Benign prostatic hyperplasia, Therapy, Thrombosis, Cerebral edema, BUN, CO2, Conference, Anuria, Pharmaceutical industry, Cryptocurrency, Security (finance), Video game, Finance, BURLINGTON

BURLINGTON, Mass., March 22, 2023 (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, 2022 and provided a business update. 

Key Points: 
  • Entered into $100 million secured debt financing agreement with funds managed by Oaktree Capital Management in October 2022.
  • scPharmaceuticals ended the fourth quarter 2022 with $118.4 million in cash, cash equivalents, restricted cash and investments, compared to $75.5 million as of December 31, 2021.
    scPharmaceuticals reported a net loss of $9.2 million for the fourth quarter of 2022, compared to $7.3 million for the fourth quarter of 2021.
  • Research and development expenses were $2.3 million for the fourth quarter of 2022, compared to $4.5 million for the fourth quarter of 2021.
  • General and administrative expenses were $7.2 million for the fourth quarter of 2022, compared to $2.2 million for the fourth quarter of 2021.

New Filtered Far UV-C Handheld Device Surface Reflectivity Study

Retrieved on: 
Wednesday, March 22, 2023
Other Manufacturing, Other Science, Technology, Research, Engineering, Manufacturing, Other Health, Building Systems, Commercial Building & Real Estate, Construction & Property, Public Transport, Other Transport, Health Technology, Rail, Air, Transport, Other Technology, Architecture, Health, Science, Columbia University, Architectural engineering, University of Colorado Boulder, University, Partner, COVID-19, Eye, Innovation system, UVC, ACGIH, Science of the Total Environment, Center for Radiological Research, Professor, Erythema, UV, American Conference of Governmental Industrial Hygienists, Disinfectant, Biophysical environment, Ozone, Conference, Radiation, Skin, Safety, Mobile phone, Fused quartz, Doctor of Philosophy

Dr. Ben Ma and Dr. Karl Linden of the University of Colorado Boulder spearheaded the work that tested surface reflectivity and safety of a filtered Far UV-C portable handheld device on a variety of common materials and compared it to the reflectivity of non-filtered Far UV-C and conventional UV-C portable handheld devices.

Key Points: 
  • Dr. Ben Ma and Dr. Karl Linden of the University of Colorado Boulder spearheaded the work that tested surface reflectivity and safety of a filtered Far UV-C portable handheld device on a variety of common materials and compared it to the reflectivity of non-filtered Far UV-C and conventional UV-C portable handheld devices.
  • The study concluded that when using the handheld filtered Far UV-C device as intended it is safe for human use without protective gear on the skin or eyes and allows for approximately 10 times longer exposure than an unfiltered Far UV-C handheld device and about 25 times longer exposure than a conventional UV-C (254nm) handheld device.
  • “The study provided needed data on UV reflection of commonly used materials and reports the relative safety of portable, handheld filtered Far UV-C devices for surface disinfection in occupied spaces, considering both the UV exposure to reflected irradiation and ozone generation.
  • Freestyle Partners provided funding support and one of their portable, handheld filtered Far UV-C devices for this study.

DermBiont Presents Positive Phase 2 Trial Data Treating Seborrheic Keratosis with SM-020 Topical Gel at American Academy of Dermatology Annual Meeting

Retrieved on: 
Wednesday, March 22, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, American Academy of Dermatology, Hypopigmentation, Therapy, SKS, Cryosurgery, Neoplasm, Food, Edema, Clinical trial, Scar, American Academy, Itch, Pain, Erythema, Patient, AKT, AAD, Risk, BID, Apoptosis, Hyperpigmentation, PLA, Entrepreneurship, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Skin, Safety, Casting, Pharmaceutical industry, Wood-plastic composite

SM-020 is a selective and potent AKT inhibitor applied by patients at home to their seborrheic keratoses (SK) lesions.

Key Points: 
  • SM-020 is a selective and potent AKT inhibitor applied by patients at home to their seborrheic keratoses (SK) lesions.
  • SKs are currently treated with ablative surgical procedures and there is currently no available topical therapy for these tumors.
  • DermBiont’s Phase 2 proof-of-concept, adaptive open-label trial tested SM-020 gel 0.1% and 1.0%, enrolling 35 subjects with 4 SK target lesions across seven treatment cohorts.
  • "We are pleased to have presented positive results from our Phase 2 adaptive, open-label trial with SM-020 at the prominent AAD annual meeting.

Palvella Therapeutics Announces Positive Topline Results from Phase 2 Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations, a Serious, Rare Genetic Skin Disease with No FDA-approved

Retrieved on: 
Thursday, March 9, 2023
Therapy, Food and Drug Administration, FDA, Disease, Bleeding, Erythema, DSM-IV codes, MD, Infection, Cellulitis, Pharmaceutical industry, Microcystic lymphatic malformation

Microcystic LM is a rare, chronically debilitating genetic disease caused by dysregulation of the PI3K/mTOR pathway.

Key Points: 
  • Microcystic LM is a rare, chronically debilitating genetic disease caused by dysregulation of the PI3K/mTOR pathway.
  • The disease is characterized by localized masses of malformed lymphatic vessels that protrude through the skin barrier and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis.
  • “The encouraging results from the Phase 2 study of QTORIN™ rapamycin build upon the large, growing evidence base supporting targeted therapeutic intervention of Microcystic LMs via the mTOR pathway.
  • Twelve individuals (n=12) with Microcystic LMs received QTORIN™ rapamycin once-daily for 12 weeks.