Multiple Sclerosis News Today

BioNxt’s BNT23001 for MS enters final animal test before human trials

Bionxt launched the final animal study needed to prepare for human testing of BNT23001, its under-the-tongue version of ...
TipRanks on MSN

Vanda Pharmaceuticals Completes Key Bioequivalence Study for Schizophrenia and Bipolar Disorder Treatment

Vanda Pharmaceuticals (($VNDA)) announced an update on their ongoing clinical study. Study Overview: The study titled ‘Crossover Bioequivalence ...
TipRanks on MSN

Pfizer’s New Study on Atirmociclib Formulations: What Investors Need to Know

Pfizer Inc (($PFE)) announced an update on their ongoing clinical study. Study Overview: Pfizer Inc. is conducting a Phase 1 study titled A PHASE ...

BioNxt Launches 15-day Sublingual Cladribine Dosing Optimization Study in Preparation for Human Bioequivalence Study

The large-mass animal crossover bioequivalence study will commence in the next two to three weeks and will be carried out ...

BioNxt Enters the Final Stretch Before Human Trials for Next-Generation MS Drug

BioNxt Solutions Inc. (CSE:BNXT) (OTCQB:BNXTF) (FSE:BXT), a bioscience company developing next-generation drug delivery technologies, has launched a 15-day dosing optimization study for its lead ...
JD Supra

FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product specific guidances to align with ICH M13A BE ...

The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...

Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End

Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its ...
Business Wire

Alpha Cognition Announces Positive Topline Results from Bioequivalence Study with ALPHA-1062 in Development for Alzheimer’s Disease

VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha Cognition,” or the “Company”), a biopharmaceutical company committed to developing novel ...
Nasdaq

BioNxt Solutions Prepares for Human Bioequivalence Study For MS

VANCOUVER, BC / ACCESS Newswire / April 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery ...
Nasdaq

Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, and Planned Commercial Formulations of Roluperidone for Treatment of Negative ...

WALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central ...
Seeking Alpha

Inhibikase Therapeutics Announces Completion of the 501 Bioequivalence Study of IkT-001Pro

BOSTON and ATLANTA, Aug. 17, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor ...
Nature

Bioequivalence Studies and Adaptive Design Methods

Bioequivalence studies are an essential component in the development and approval of generic pharmaceutical products, ensuring that they perform similarly to their reference counterparts. These ...