Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. The Appeal of In-Licensing In-licensing has emerged as a strategic approach for pharmaceutical companies to expand their product offerings without incurring the high costs and risks associated with drug development.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.

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Generic Drugs Development Bioequivalency Drugs 52

FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.

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Bioequivalency Generic Drugs Packaging Packaging 59

pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

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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.

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The Pharma Data

AUGUST 5, 2020

The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults . ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. At this point, one must wonder why the U.S. About those copay cards.

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The Pharma Data

SEPTEMBER 26, 2021

The CHMP’s positive opinion will now be mentioned the ecu Commission (EC), which grants marketing authorizations for medicines in Europe. “We Head of Research and Development at Biogen.

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Clinical Trials Clinical Trials Bioequivalency Medicine 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. percent vs. 32.1 or visit your respective country’s product website. References: 1 National Multiple Sclerosis Society.

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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. 2 It affects an estimated 7.5

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Worldwide Clinical Trials

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

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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.

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Generic Drugs Drugs Branding Bioequivalency 89

The Pharma Data

MAY 3, 2021

How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects ( STAT ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Medtech.

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Gene Therapy Vaccination Vaccine Bioequivalency 52