hearing loss prevention chemotherapy fennec

Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for PEDMARK

RESEARCH TRIANGLE PARK, NORTH CAROLINA — Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month…

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otonomy hearing loss drug

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413

SAN DIEGO, CALIFORNIA — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-413 in subjects with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of OTO-413, a sustained exposure…

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hearing loss prevention chemotherapy fennec

Development of Ototoxicity Drug, PEDMARK™, Faces Setback Following FDA Response

RESEARCH TRIANGLE PARK, NORTH CAROLINA — Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application for PEDMARK™ (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity…

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auris medical

Auris Medical Announces Completion of Enrollment in Phase 2 Study for Vertigo Drug, AM-125

Auris Medical Holding Ltd., a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, announced the completion of patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125). The company says that it expects to release interim results…

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CILcare Partners with Vertidiag to Develop Solutions for People with Vestibular Disorders

CILcare, a research and development company specializing in the field of hearing disorders, has announced a strategic partnership with the start-up Vertidiag, a company specialized in balance disorders. According to the announcement, “by combining their unique know-how, CILcare and Vertidiag can propose a complete service offering to identify and develop therapeutic solutions for people suffering…

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hough hearing loss drug

Oblato Biotech Company Acquires Hearing Loss Drug Discovered by Hough Ear Institute Scientists

OKLAHOMA CITY, OKLAHOMA — Hough Ear Institute (HEI), a nonprofit based in Oklahoma City, has annoucned that its pharmaceutical partner, Auditus LLC, a wholly owned subsidiary of Otologic Pharmaceutics Inc. (OPI), has entered into an agreement with Oblato Inc. Oblato assumes exclusive rights to a drug known as NHPN-1010 to advance clinical research aimed at preserving and…

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strekin hearing loss drug

Strekin AG Secures Financing to Complete Development of STR001 in Sudden Sensorineural Hearing Loss

BASEL, SWITZERLAND — Strekin AG, a clinical stage biopharmaceutical company, announced today that it has successfully closed a Series A financing round totaling CHF 2.82 Million (~$2.86M USD) from private investors. According to the announcement, the funds will enable Strekin to conclude its ongoing Phase 3 clinical trial of STR001 in Sudden Sensorineural Hearing Loss,…

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drug treatment hearing loss age related

New Drug Under Development to Prevent Age-Related Hearing Loss

TAMPA, FLORIDA — The first ever medication to treat age-related hearing loss could potentially receive FDA approval through a comprehensive study being conducted at the University of South Florida. Robert Frisina, PhD, chair of the USF Medical Engineering Department and director of the USF Global Center for Hearing and Speech Research, and his team were…

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frequency therapeutics financing development fx-322

Frequency Therapeutics Raises $62 Million in Latest Financing Round to Support Hearing Loss Drug Development

WOBURN, MASSACHUSSETTS — Frequency Therapeutics, a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the closing of a $62.0 million Series C financing. Frequency will use the proceeds to support the clinical development of FX-322, a regenerative therapeutic…

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sensorion hearing loss

Sensorion Receives FDA Investigational New Drug Clearance for Arazasetron (SENS-401)

MONTPELLIER, FRANCE — French biotech firm Sensorion, which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announced today that it has received the Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on…

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