Drug Patent Watch

DECEMBER 10, 2024

Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play a vital role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. One of the main challenges is ensuring bioequivalence with the innovator drug. EU, and other regions.

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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. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

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Bioequivalency Generic Drugs Packaging In-Vivo 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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Bioequivalency Drugs Production Manufacturing 52

Camargo

JULY 8, 2021

Researchers at the Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have observed that MAOIs might help the immune system attack cancer. Although still available as generics, for the most part they have been replaced by newer drugs with fewer side effects. ” .

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Development Bioequivalency Gene Expression Drugs 130

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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Bioequivalency FDA Approval Medicine Bioavailability 40

pharmaphorum

JANUARY 17, 2022

The case was brought by the US Federal Trade Commission (FTC) and US states New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia, for Shkreli’s actions that blocked any competition with its key medicine to preserve monopoly profits.

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Bioequivalency Generic Drugs Contamination Drugs 45

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. You should not place undue reliance on these statements.

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Trials Medicine Production Containment 52

Druggist

MARCH 25, 2021

Read more about initiating the treatment with a progestogen-only pill in the product information leaflet. Product information leaflets for both Cerelle and Cerazette list precisely the same common and uncommon side effects. Source: *Cerelle product information leaflet, **Cerazette product information leaflet .

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Branding Bioequivalency Pharmacy Generic Drugs 98

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

Reportedly, the cost of production for molnupiravir stands at about $17.74. 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). Merck’s molnupiravir, now approved for use in the U.K., costs about $700.

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Regulation Drugs Bioequivalency Vaccine 218

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 or visit your respective country’s product website. Head of Research and Development at Biogen. Source link: [link].

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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. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved. percent).

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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. .” The U.S. are breastfeeding or plan to breastfeed.

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Bioequivalency Vaccine Vaccination 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. Indeed, there is a continuing trend towards combination products where treatments can target multiple complementary points within disease pathology. The MAA file in the E.U.

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Gene Clinical Trials Clinical Trials Gene Therapy 204

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. 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. Association for Accessible Medicines.

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Generic Drugs Drugs Branding Bioequivalency 89