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) ...
The American Journal of Managed Care

Study Identifies Factors That Influence Bioequivalence Evaluations of Insulin Biosimilars

These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote. Factors that may affect the bioequivalence of test ...
Business Insider

Biohaven Doses First Subject in Pivotal Bioequivalence Study with Sublingual BHV-0223

NEW HAVEN, Conn., Nov. 6, 2017 /PRNewswire/ -- (NYSE: BHVN) - Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven" or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc.
Nasdaq

Company to Request Pre-NDA Meeting with U.S. Food and Drug Administration

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 ...
Medscape

Bioequivalence Study of Three Ibuprofen Formulations After Single Dose Administration in Healthy Volunteers

This phase I study (study code 398B6) was a single-dose, randomized, open label, three-treatment, three-period, three-sequence cross-over with a wash-out period of 7-10 days. Patients were eligible ...
Morningstar

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

VANCOUVER, BC / ACCESS Newswire / October 21, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug ...
FierceBiotech

Egalet's Abuse-Deterrent, Extended-Release Morphine Demonstrates Bioequivalence at 60 mg Dose

WAYNE, Pa., June 25, 2015-- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain ...

Biogen Advances New SKYCLARYS Formulation in Early Trial, Supporting Long-Term Rare Disease Strategy

Biogen Inc. announced an update on their ongoing clinical study. Claim 70% Off TipRanks Premium. Unlock hedge fund-level data and powerful investing tools for smarter, sharper dec ...
JD Supra

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) ...
Seeking Alpha

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 ...