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TEL AVIV, Israel and RALEIGH, NC, May 26, 2021 /PRNewswire/ RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced receipt of two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) covering opaganib
[1] and RHB-107 (upamostat)
[2] as methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus.
Both opaganib and RHB-107 are novel COVID-19 therapeutic candidates, in oral pill form, with dual mechanism of action effects. Both are host-targeted and are therefore expected to be effective against emerging viral variants with various mutations in the spike protein.
RedHill Biopharma Receives Allowances for U S Patent Applications Covering Opaganib and RHB-107 for COVID-19 yahoo.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from yahoo.com Daily Mail and Mail on Sunday newspapers.
President Joe Biden is yet to nominate a commissioner for the Food and Drug Administration. But he is reportedly considering many candidates, including Gayatri Rao, who previously worked at the FDA and is currently vice president and global product head at Rocket Pharmaceuticals, a leading multi-platform gene therapy company.
The Biden administration has expanded its shortlist of candidates to lead the Food and Drug Administration, the Wall Street Journal has reported, citing a person familiar with the process. Rao was named as a potential nominee in the report along with several others.
In the past, Rao served as director of the Office of Orphan Products Development within the U.S. Food and Drug Administration where she was responsible for implementing statutory programs focused on promoting the development of medical products for rare diseases. As director, Rao served as the FDAâs rare disease lead for interactions with Congress, international regulatory counterparts, other
Orphan drug development advances the development of products for rare diseases. Learn more about the Office of Orphan Products Development at a free CE webinar hosted by the FDA. Register here. This webinar is accredited by the Accreditation Council for Pharmacy Education (ACPE) and participants will receive 1.00 Interprofessional Continuing Education (IPCE) credit.
Published: Apr 13, 2021
BOSTON, April 13, 2021 (GLOBE NEWSWIRE) Akouos, Inc. (NASDAQ: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. Akouos anticipates that it will submit an investigational new drug application (IND) for AK-OTOF in the first half of 2022.
Otoferlin gene (
OTOF gene. The
OTOF gene encodes otoferlin, a protein that enables the inner hair cells of the cochlea to release neurotransmitter vesicles in response to stimulation by sound to activate auditory neurons. Most individuals with