BioSpace News Archive

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.

Veeva Systems (NYSE: VEEV) today announced that PharmaEssentia has adopted Veeva Data Cloud to support the launch of BESREMi.

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.

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.

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).

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.

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.

Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection.

Vivos Therapeutics, Inc today announced that it has received acceptance from a Centers for Medicare & Medicaid Services Pricing, Data Analysis and Coding (“PDAC”) contractor for its mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA and snoring in adults.

KemPharm, Inc. announced today top-line results from its clinical trial exploring the safety and pharmacokinetics of serdexmethylphenidate (SDX) delivered at doses higher than those studied as part of the AZSTARYS® development program.