GEN

Bioequivalence, Bioassays, and Biowaivers: How Integrated Testing Can Accelerate Generic Drug Development

Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...
FiercePharma

FDA shares advice on bioequivalence studies for different dosage forms

The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...
JD Supra

New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the ...
Drug Store News

FDA announces ANDA prioritization pilot to support U.S. generic drug manufacturing, testing

On Friday, the Food and Drug Administration announced a new pilot prioritization program for the review of abbreviated new drug applications that aims to spur and reward investment in U.S. drug ...
JD Supra

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...
Managingip.com

Beyond generic testing

Newman disagreed with the majority's narrow reading of the statute as focusing on bioequivalence testing by generic manufacturers, noting that the statute had been interpreted "expansively," and ...
Nasdaq

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

Following successful small-animal trials that confirmed bioequivalence, BioNxt is now taking the final preclinical step to prepare its sublingual Cladribine formulation for human testing. The upcoming ...
Medscape

FDA Concerned Over Bioequivalence of Two Generic ADHD Meds

An internal US Food and Drug Administration (FDA) re-examination of previously submitted data has raised concerns that two generic medications used to treat attention ...
RAPS

FDA Releases Draft Guidance for Lenalidomide Bioequivalence Testing

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GEN

FDA Clears Sandoz’ Generic Competitor to Astellas Transplant Drug

Astellas will push the agency for more rigorous bioequivalence testing of generic immuosuppressants. Sandoz will launch the first generic version of Astellas’ transplant rejection drug, Prograf ...
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 ...
ascopubs.org

Randomized, Parallel Group, Open-Label Bioequivalence Trial of Intramuscular Pegaspargase in Patients With Relapsed Acute Lymphoblastic Leukemia

Pegylated asparaginase is comparatively safer than native asparaginase in the management of acute lymphoblastic leukemia (ALL). However, the high price and nonavailability in low- and middle-income ...