Camargo

NOVEMBER 11, 2020

Approval of the Month: Companion Diagnostic for Bayer’s Vitrakvi Should Lead to Improved Patient Outcomes. In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics.

Development 242

Development Bioequivalency Generic Drugs Production 242

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

APRIL 11, 2023

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40

The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History. percent vs. 32.1 3 Zhao Y, et al.

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. Visit [link] or call 1-800-FDA-1088.

Bioequivalency 52

Bioequivalency Vaccination Vaccine Medicine 52

Worldwide Clinical Trials

MAY 30, 2024

was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. Edaravone (Radicava ORS) (Oral) The oral suspension uses the same active ingredient as the approved IV infusion for edaravone and may be taken orally or via a feeding tube.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

Drug Patent Watch

JANUARY 7, 2025

They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. For example, instead of saying “bioequivalent,” you might say “works the same way in the body.” Association for Accessible Medicines.

Generic Drugs 89

Generic Drugs Drugs Branding Bioequivalency 89