Ototoxicity

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.

Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand

Retrieved on: 
måndag, mars 18, 2024
Civil service commission, Neuroblastoma, Ototoxicity, Partnership, Central nervous system, ANZ, Risk, FENC, Patient, Hepatoblastoma, Neoplasm, Cancer, MHRA, TSX, Hearing loss, European, Cisplatin, Safety, European Commission, Liver, Arnold & Porter, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C. and UXBRIDGE, United Kingdom, March 17, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, and Norgine, a leading European specialist pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to

Key Points: 
  • Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories.
  • It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe.
  • PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023.
  • The studies compared PEDMARQSI plus cisplatin-based regimens to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients.

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.

Sensorion Reports Full-Year 2023 Financial Results and Business Update

Retrieved on: 
torsdag, mars 14, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bioreactor, Malignancy, Cell, Chemistry, Patient, Orphan, Good manufacturing practice, Health care, CMC, G&A, Molecular biology, Quality of life, European Medicines Agency, Science, Clinical trial, Cisplatin, Therapy, Hertz, Neoplasm, CIO, Congress, Huber loss, Partnership, Ageing, EMA, Hearing loss, GMP, Cochlea, Biochemistry, Safety, Language, Perilymph, G7, Medication, Control, AAV, PTA, IHC, Pasteur Institute, CDMO, Communication, Genetics, Research, KOL, Ear, POC, FDA, Ototoxicity, GJB2, ABR, CTA, ANSM, Audiogram, Platinum, Investment company, Congenital hearing loss, Pathology, Presbycusis, Hearing, Pharmaceutical industry

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.

Key Points: 
  • Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: “Over the past months, Sensorion has successfully achieved all the major milestones on its roadmap.
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV SENS-501 clinical batches at 200L scale.
  • On April 6, 2023, Sensorion announced the candidate selection for GJB2-GT during its gene therapy focused R&D Day.

Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand

Retrieved on: 
måndag, mars 18, 2024
Civil service commission, Neuroblastoma, Ototoxicity, Partnership, Central nervous system, ANZ, Risk, FENC, Patient, Hepatoblastoma, Neoplasm, Cancer, MHRA, TSX, Hearing loss, European, Cisplatin, Safety, European Commission, Liver, Arnold & Porter, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C. and UXBRIDGE, England, March 18, 2024 /PRNewswire/ -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, and Norgine, a leading European specialist pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to

Key Points: 
  • Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories.
  • It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe.
  • The studies compared PEDMARQSI plus cisplatin-based regimens to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients.
  • Moelis & Company LLC acted as financial advisor, and LaBarge Weinstein LLP acted as legal advisor to Fennec.

Fennec Pharmaceuticals Reports Preliminary Unaudited Net Revenue for Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
torsdag, februari 29, 2024
Incidence, Osteosarcoma, Fennec, FDA, TSX, Food, Neuroblastoma, Germ cell tumor, Hepatoblastoma, Risk, Literacy, Safety, Audit, Cisplatin, Hearing loss, Medulloblastoma, Kool-Aid, Ototoxicity, Food and Drug Administration, Patient, Survival, FENC, COG

RESEARCH TRIANGLE PARK, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced preliminary unaudited fourth quarter and full-year 2023 net revenues.

Key Points: 
  • ~ Company Expects to Report 2023 Fourth Quarter and Audited Full-Year Results on or about March 26, 2024 ~
    RESEARCH TRIANGLE PARK, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced preliminary unaudited fourth quarter and full-year 2023 net revenues.
  • The information in this press release is based upon preliminary unaudited information and management estimates for the fourth quarter 2023 and is subject to the completion of Fennec’s financial closing procedures and year end audit.
  • Preliminary Unaudited 2023 Fourth Quarter Revenue and Year End Performance:
    Fourth quarter 2023 net revenues are expected to be approximately $9.2 to $9.7 million, which represents approximately a 41-49% increase over the third quarter of 2023.
  • Fennec expects to report its 2023 fourth quarter and audited full-year year results of operations on or about March 26, 2024.

Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study

Retrieved on: 
torsdag, februari 15, 2024
Culture, Survivor, CMO, Study Group, Ototoxicity, Risk, Gesellschaft mit beschränkter Haftung, Ear, Cisplatin, Therapy, Fatigue, Life expectancy, The German, Patient, Social, Testicular cancer, Cancer, Pharmaceutical industry

TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.

Key Points: 
  • TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.
  • Germ-cell testicular cancer is the most common cancer among young men, with incidence rates continuously increasing.
  • In preclinical models, ACOU085 has demonstrated its significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity.
  • "The enrollment of the first patient into our ACOU085 Clinical Phase 2 program marks a further major milestone in our efforts to finally make acute and subacute forms of hearing loss treatable" said Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics.

Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study

Retrieved on: 
torsdag, februari 15, 2024
Culture, Survivor, CMO, Study Group, Ototoxicity, Risk, Gesellschaft mit beschränkter Haftung, Ear, Cisplatin, Therapy, Fatigue, Life expectancy, The German, Patient, Social, Testicular cancer, Cancer, Pharmaceutical industry

TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.

Key Points: 
  • TÜBINGEN, Germany, Feb. 15, 2024 /PRNewswire/ -- Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study.
  • Germ-cell testicular cancer is the most common cancer among young men, with incidence rates continuously increasing.
  • In preclinical models, ACOU085 has demonstrated its significant potential to reduce cisplatin-induced hearing loss and preserve outer hair cells from ototoxicity.
  • "The enrollment of the first patient into our ACOU085 Clinical Phase 2 program marks a further major milestone in our efforts to finally make acute and subacute forms of hearing loss treatable" said Dr. Tim Bölke, CEO and CMO of Acousia Therapeutics.

Sensorion Announces a €50.5 Million Financing With Participation From New and Existing US and European Healthcare Specialist Investors

Retrieved on: 
fredag, februari 9, 2024
Health, Medical Devices, Genetics, Research, Science, Pharmaceutical, Biotechnology, Stifel, Sofinnova, Ototoxicity, Quality of life, GJB2, Huber loss, Euronext Growth, Code, Chair, SVB Securities, EUR, Pasteur Institute, Clinical trial, Patient, Reserved, Person, Commercial code, Audiology

The settlement-delivery of the Reserved Offering is expected to take place around February 13, 2024, subject to customary conditions.

Key Points: 
  • The settlement-delivery of the Reserved Offering is expected to take place around February 13, 2024, subject to customary conditions.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: “We are delighted to announce today’s successful capital raise of EUR 50.5 million.
  • This strengthened shareholder base reinforces Sensorion’s ambition to advance its pipeline of innovative therapies intended to improve the quality of life of patients suffering from hearing disorders.
  • Leerink Partners LLC (“Leerink Partners”) and Stifel Europe AG (“Stifel”) are acting as lead agents in connection with the Reserved Offering.

FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin

Retrieved on: 
torsdag, februari 1, 2024
Hypothermia, Sodium nitrite, Fatigue, Ototoxicity, Cisplatin, Patient, FENC, STS, FDA, Restless, Kidney, TSX, Argyreia nervosa, Communication, Food, Methemoglobinemia, Risk, Dermatitis, Headache, Potassium chloride, Pharmaceutical industry

PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Key Points: 
  • PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
  • The FDA reminded health care providers that as stated in PEDMARK’s prescribing information , PEDMARK is not substitutable with other sodium thiosulfate products.
  • Sodium nitrite is co-packaged with sodium thiosulfate as a separate vial in some products; it is not present in PEDMARK.
  • The FDA encourages those with any questions to contact [email protected].