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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
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BioVie Secures Up to a $25.0 Million Debt Facility with Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P.
BioVie Inc. entered into a debt facility with Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P.
December 1, 2021
·
4 min read
Business
Beyond Air® Expands Leadership Team with the Appointment of Dr. Andrew Colin to Chief Medical Officer
Beyond Air, Inc. announced the appointment of Dr. Andrew Colin to the newly created position of Chief Medical Officer, effective December 1, 2021.
December 1, 2021
·
8 min read
Biotech Bay
Zogenix Announces U.S. FDA Acceptance for Priority Review of Supplemental New Drug Application for FINTEPLA® (Fenfluramine) for the Treatment of Seizures
Zogenix today announced the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the company’s supplemental New Drug Application (sNDA) for the use of FINTEPLA ® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
December 1, 2021
·
6 min read
Biotech Bay
Eiger BioPharmaceuticals Announces Presentations at Upcoming HEP DART 2021 Meeting
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), today announced that the 24th Biennial HEP DART 2021 Frontiers in Drug Development for Hepatology meeting being held December 5-9 in Cabo San Lucas, Mexico.
December 1, 2021
·
4 min read
Drug Development
Harmony Biosciences Announces Plans To Initiate Phase 3 Clinical Trial For Treatment Of Idiopathic Hypersomnia
Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), today announced that the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for pitolisant for the treatment of idiopathic hypersomnia (IH).
December 1, 2021
·
10 min read
Noxopharm In-Licenses Novel RNA Technology From Hudson Institute of Medical Research
Australian clinical-stage drug development company Noxopharm (ASX:NOX) has in-licensed novel RNA technology developed by Hudson Institute of Medical Research,
December 1, 2021
·
3 min read
Business
Tranquis Therapeutics Strengthens Leadership Team with Additions of Janet Hurt, MPH, as SVP of Clinical Evidence Generation and Faisal Shawwa, MBA, as SVP of Finance
Tranquis Therapeutics today announced it has strengthened its management team with the addition of Faisal Shawwa, MBA, as Senior Vice President of Finance and Administration and Janet Hurt, MPH, as Senior Vice President of Clinical Evidence Generation.
December 1, 2021
·
3 min read
BioForest
CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission
CytoDyn Inc. today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week.
December 1, 2021
·
7 min read
Pharm Country
Dr. Miguel de la Garza, President of the Florida Society of Interventional Pain Physicians and Renowned Physician at Surgery Partners, Adopts Milestone Scientific’s CompuFlo® Epidural Instrument for Pain Management
Milestone Scientific Inc., a leading developer of computerized drug delivery instruments, that provide painless and precise injections, announced that Dr. Miguel de la Garza has begun incorporating the CompuFlo® Epidural instrument into his practice for pain management, following approval by Surgery Partners, one of the largest and growing surgical services business in the country.
December 1, 2021
·
4 min read
FDA Reissues LumiraDx Fast Lab Solutions’ EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions
LumiraDx (Nasdaq: LMDX) announced today that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-CoV-2 RNA STAR Complete, a rapid, nucleic acid amplification technology for high sensitivity, high throughput COVID-19 testing has been reissued.
December 1, 2021
·
5 min read
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