Sensorion Gets Positive Recommendation for Clinical Trial of Drug Candidate for Cisplatin-Induced Ototoxicity
Sensorion was recommended to continue the study of a drug candidate for the prevention of Cisplatin-Induced Ototoxicity (CIO).
Tag: ototoxicity
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Fennec Resubmits FDA Application for Pedmark
Fennec Pharmaceuticals Inc announced that the FDA has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
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WHO Releases First ‘World Report on Hearing’
Nearly 2.5 billion people worldwide ─ or 1 in 4 people ─ will be living with some degree of hearing loss by 2050, warns the World Health Organization’s (WHO) first World Report on Hearing.
Article Explores COVID-19 Treatment and Auditory Safety
Repurposing approved compounds carries both opportunities and risks, including a high risk of ototoxicity based on existing data on the drug classes under consideration.
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Opioid Use Can Cause Deafness, Rutgers Researchers Say
Researchers identified 41 people with opioid exposure who experienced full or partial hearing loss or tinnitus, likely caused by toxicity to the ear. More than half had used heroin, followed by oxycodone, methadone, and tramadol; 88% had only one known exposure.
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Fennec Pharmaceuticals Reports Complete Response Letter Issuance from FDA for Pedmark Application
According to the CRL, after recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of PEDMARK.
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Hearing Loss May Affect Neurocognitive Abilities of Childhood Cancer Survivors
Findings show that survivors with severe hearing loss are at a significantly increased risk for neurocognitive deficits, independent of what type of therapy they receive.
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‘Forbes’ Article Examines Link Between COVID-19 and Potential Hearing Loss
In an article on “Forbes,” professor and journalist Bruce Y. Lee reviews the evidence currently available regarding the link between COVID-19 and hearing loss.
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Fennec Announces FDA Filing Acceptance for Ototoxicity Drug, Pedmark
PEDMARK is said to be an investigational drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors.
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Sensorion Presents Preclinical Data at ARO MidWinter Meeting 2020
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a clinical-stage biotech company which specializes...
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Education May Help Cancer Survivors Cope with Hearing Loss
Researchers involved with a qualitative study published in Cancer concluded that clinicians play...
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E.A.R. Launches Forensic Audiology Referral Services
For those companies or individuals who have a concern about hearing damage that may have been...
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Researchers Find Proteins Associated with Hair Cell Formation
The proteins, described in a report published June 12 in “eLife,” may hold a key to future therapies to restore hearing in people with irreversible deafness. An article summarizing the research was published on the Johns Hopkins Medicine website.
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Sensorion Receives IND Clearance from FDA on Hearing Loss Drug
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
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Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
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Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
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Cold Spring Harbor Laboratory Press Releases ‘Function and Dysfunction of the Cochlea’
The book describes major advances in our understanding of the pathogenic processes underlying various forms of hearing loss and the emergence of treatments for deafness.
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CILcare Initiates Second Phase of Tinnitus Research Project DETECT
In Phase 1, CILcare was reportedly able to correlate electrophysiology, manganese-enhanced magnetic resonance imaging (MEMRI), and behavioral assessments that define a preclinical model for detecting tinnitus. In Phase 2, CILcare will adapt the preclinical model to humans.
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