XTalks

NOVEMBER 6, 2024

This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms. In the pharmaceutical segment, Gelteq advances its lead product — a gel-based pain management therapy — through the US Food and Drug Administration (FDA)’s 505(b)(2) pathway.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

World of DTC Marketing

FEBRUARY 21, 2022

Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment. Merck’s molnupiravir, now approved for use in the U.K., costs about $700. At this point, one must wonder why the U.S.

Regulation 218

Regulation Drugs Bioequivalency Vaccine 218

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

Worldwide Clinical Trials

MAY 30, 2024

Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

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. .” The U.S.

Bioequivalency 52

Bioequivalency Vaccine Vaccination Medicine 52

The Pharma Data

FEBRUARY 1, 2021

The addition of the IM administration of Plegridy to Biogen’s MS portfolio offers another important option at a time when MS patients are being encouraged to discuss their MS treatment and considerations around COVID-19 vaccination with their physicians.1,2 MS, the coronavirus and vaccines – updated global advice. percent vs. 32.1

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78