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Alpha Cognition announces bioequivalence study results for Alzheimer’s

Pharma Times

In 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 people aged 65 and over

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Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study

BioTech 365

Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study Phase 1 study demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, … Continue reading → GlobeNewswire

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CRO Data Integrity Concerns Have Pharma Companies Scrambling to Repeat Bioequivalence Studies

BioSpace

The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019

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The Composition and Value of a Portfolio Analysis

Camargo

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing.

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The drug industry continues to dare regulation

World of DTC Marketing

A new study estimates the causal effects of coupons for branded drugs without bioequivalent generics using variation in coupon introductions over time and comparing differential responses across enrollees in commercial and Medicare Advantage plans.

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In the News: October Regulatory and Development Updates

Camargo

The guidance clarifies the differences between an RLD and an RS for use during in vivo bioequivalence studies to support an ANDA and how the Agency determines the appropriate RS to designate in the Orange Book.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

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.

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Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

Drugs with an AB rating meet the required bioequivalence. With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future.

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Cerelle vs Cerazette: Are they really the same?

Druggist

Generic medicines must go through bioequivalence studies to show that generic medicine produces the same amount of active drug in the body. Bioequivalent studies may involve humans or animals (EMA, 2012). .

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Can a CRL Be Final Agency Action: One Step Closer to Finding Out

FDA Law Blog

Circuit, their client Nostrum Laboratories sought judicial review after FDA agreed to allow a certain type of study to establish bioequivalence for generic theophylline, Nostrum conducted those studies, and then FDA issued a CRL asking for new, time-consuming, expensive studies of a different sort.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

On the contrary, due to the complexity involved in comparing the structures of biologics, selecting the correct sampling times to prove bioequivalence for both PK and biomarkers is of primary importance.

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TE Codes 101: FDA Guidance Teaches Basics of Therapeutic Equivalence Codes

FDA Law Blog

TE Codes, FDA explains, are assigned for multisource prescription products based on pharmaceutical equivalence, bioequivalence, and product safety and efficacy profile for the conditions of use specified in the labeling. If the first letter of the TE code is an “A,” the products are therapeutically equivalent; if the first letter is a “B,” there are bioequivalence questions that are unresolved. By Sara W.

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Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

The FDA Law Blog

This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. By Faraz Siddiqui & Deborah L.

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In the News: June 2021 Regulatory and Development Updates

Camargo

In June, the FDA issued an updated (draft) guidance titled “ Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.”

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How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling.

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NewAmsterdam’s CETP renaissance gathers pace

Pharma Phorum

NewAmsterdam said it is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe that will be tested in a phase 3 trial, as well as a study to make sure the formulation is bioequivalent to each drug delivered separately.

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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. When you lose count of how many folks have the same suspicion about a prescription medication, action is compulsory.

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New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

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As Russia’s clinical trials sector falls, Ukraine rebuilds

Pharmaceutical Technology

The ongoing trials in Russia are mainly bioequivalence studies recruiting healthy participants, Andrianov notes. August 24 marks six months since the start of Russia’s war in Ukraine.

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Headache for Zosano as FDA turns down migraine patch

Pharma Phorum

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. RANCHO CUCAMONGA, Calif.,

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New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

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New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

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Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

The Pharma Data

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. Bioequivalence between the two dosing regimens was confirmed and data show that participants receiving Plegridy through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration (14.4 CAMBRIDGE, Mass.,

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Jailed pharma exec fined £47m and banned from industry

Pharma Phorum

The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production. The man who sent the price of lifesaving drug Daraprim (pyrimethamine) rocketing from $13.50 a tablet to $750 overnight has been ordered to repay $64.6m (£47m).

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The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

The Pharma Data

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SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis

The Pharma Data

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.

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Smoking is the leading preventable cause of death in the world. However, prior to 1900, tobacco smoking was an uncommon sight.

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CHMP Recommends VUMERITY® (diroximel fumarate) for Approval within the European Union as a Treatment for Relapsing-Remitting MS

The Pharma Data

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA.

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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

TLC’s Ampholipad (amphotericin B liposome for injection) for the treatment of systemic fungal infections, is the only complex generic drug which has shown bioequivalence to Gilead’s AmBisome ® in all three forms, proving its sameness as the originator. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

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Clinical Catch-Up: December 21-25 | BioSpace

The Pharma Data

Acer Therapeutics announced full enrollment of trial evaluating the bioequivalence of ACER-001 compared to Buphenyl (sodium phenylbutyrate) for urea cycle disorders. Even with the holidays among us, there were a number of clinical trial announcements. Here’s a look. COVID-19-Related.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product.

Insulin 69
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Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

The Pharma Data

Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study.

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Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

The Pharma Data

Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Posted 03 May 2021 | By Michael Mezher . Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. . In Focus: US.