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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
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Business
CENTENE ANNOUNCES GOVERNANCE AND BOARD OF DIRECTORS CHANGES
Five New Directors to Join the Board, James Dallas to Become Independent Chairman in 2022 and Lead Independent Director Immediately.
December 14, 2021
·
15 min read
Braxia Scientific Achieves Milestone as Landmark Psilocybin Clinical Trial Commences, Participants Receive First Doses of Psilocybin
Braxia Scientific Corp. has reached a milestone as the first Health Canada-approved multiple-dose psilocybin clinical trial which commenced with first patients dosed in November 2021.
December 14, 2021
·
8 min read
Business
PharmaEssentia Selects Veeva Data Cloud to Support Launch of Novel Therapy for Rare, Chronic Blood Cancers
Veeva Systems (NYSE: VEEV) today announced that PharmaEssentia has adopted Veeva Data Cloud to support the launch of BESREMi.
December 14, 2021
·
2 min read
Genetown
Alnylam Submits Regulatory Applications to the U.S. Food and Drug Administration and European Medicines Agency to Support Label Expansion for OXLUMO® for the Treatment of Advanced Primary Hyperoxaluria Type 1
Alnylam Submits Regulatory Applications to the U.S. Food and Drug Administration and European Medicines Agency to Support Label Expansion for OXLUMO ® for the Treatment of Advanced Primary Hyperoxaluria Type 1.
December 14, 2021
·
10 min read
Drug Development
OnKure Therapeutics Announces Positive Topline First-in-Human Phase 1 Results for OKI-179
OnKure, Inc. today announced positive topline results from the first-in-human Phase 1 trial of OKI-179, the Company’s oral Class 1 histone deacetylase (HDAC) inhibitor.
December 14, 2021
·
4 min read
Pharm Country
TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab as a Treatment for Patients with Relapsing Forms of Multiple Sclerosis
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, as a treatment for patients with relapsing forms of multiple sclerosis (RMS).
December 14, 2021
·
7 min read
Drug Development
Alterity Therapeutics Announces First Regulatory Authorization to Proceed with ATH434 Phase 2 Clinical Trial
Alterity Therapeutics today announced that the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has authorized Alterity’s Phase 2 clinical trial for ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.
December 14, 2021
·
6 min read
Drug Development
OpGen subsidiary Ares Genetics announces the strategic expansion of ARESdb proprietary contents
Following successful completion of Phase 1, Ares Genetics has now entered into Phase 2 of its collaboration with a leading U.S. CRO and reference lab, gaining access to 1,000 proprietary clinical isolates from key pathogens ARESdb contents has grown by more than 40% in a year.
December 14, 2021
·
6 min read
Business
Vera Therapeutics Announces Appointment of Kimball Hall to Board of DirectorsPharmaceutical industry leader brings more than 30 years of quality, regulatory and manufacturing experience
Vera Therapeutics, Inc. today announced the appointment of Kimball Hall to its board of directors.
December 14, 2021
·
3 min read
Business
Centessa Pharmaceuticals Initiates Global Phase 3 ACTION Study of Lixivaptan in Autosomal Dominant Polycystic Kidney Disease
Centessa Pharmaceuticals plc together with subsidiary Palladio Biosciences, Inc. today announced the initiation of active recruitment of the global ACTION Study, a pivotal Phase 3 clinical trial evaluating lixivaptan as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD).
December 14, 2021
·
12 min read
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