The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. Overall, 311 patients were randomized and treated with RIABNI, rituximab RP approved in the EU (rituximab-EU) or rituximab RP approved in the US (rituximab-US).

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

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The Premier Consulting Blog

APRIL 15, 2024

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

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PerkinElmer

JANUARY 7, 2022

There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. Furthermore, nearly one third of drugs get withdrawn from the market post approval due to safety concerns. link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet].

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Drugs FDA Approval Pharmacokinetics Drug Development 52

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). (December 2022).

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL.

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Biosimilars Pharmacokinetics FDA Approval Packaging 40

The ChEMBL-og

JUNE 13, 2023

ChEMBL database version ChEMBL 33 release notes _ # This version of the database, prepared on 31/05/2023 contains: 2,399,743 compounds (of which 2,372,674 have mol files) 3,051,613 compound records (non-unique compounds) 20,334,684 activities 1,610,596 assays 15,398 targets 88,630 documents BioAssay Data Sources: Number Assays: Number Compound Records: (..)

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 months (95 percent CI, 6.9 – NE). [7].

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements. And if they do participate, they may be more likely to drop out prior to reaching a study endpoint.

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.

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Drug Target Review

SEPTEMBER 19, 2023

In spite of current success and possibility to be a successful cell technology model, the integration of organ-on-chips into drug development process needs more optimisation to be validated for FDA approval.

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The Pharma Data

SEPTEMBER 7, 2021

Because of its selectivity for oxycodone, the vaccine will not interfere with FDA-approved medications, including methadone, buprenorphine, naltrexone and naloxone, potentially offering a long-lasting, safe and cost-effective alternative that is complementary to standard medical intervention for opioid use disorders.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature. Human factors.

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DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. The National Institutes of Health (NIH) Clinical Collection , a library of FDA-approved drugs, is widely used for HTS in drug repurposing initiatives.

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The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. UNIVERSE was conducted in two parts.

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The Pharma Data

MAY 17, 2023

About the FENopta study The FENopta study is a global Phase II, randomised, double-blind, placebo-controlled 12-week study to investigate the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 years with RMS. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.

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The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

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The Pharma Data

NOVEMBER 26, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Galactosidase-A enzyme.

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The Pharma Data

DECEMBER 29, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Galactosidase-A enzyme.

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

AUGUST 30, 2021

Part B of the Phase 3 trial was informed by Part A , an open-label, single-ascending-dose, sequential cohort Phase 2 trial designed to assess the pharmacokinetics and safety of Dupixent in children aged 6 months to 5 years with uncontrolled severe atopic dermatitis.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

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Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively.

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The Pharma Data

SEPTEMBER 8, 2021

Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate. About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Abstract Lecture. September 12, 2021. 2:45-2:55 a.m. ePoster (on-demand only). Ubrogepant.

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Doctors Treatment Trials Clinical Trials 52

The Pharma Data

APRIL 11, 2021

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. Retevmo is an U.S.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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The Pharma Data

JANUARY 21, 2021

Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients. . Please see full Prescribing Information for more details. Use in Specific Populations.

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Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . In the case of Kloxxado, the applicant used the agency’s safety and effectiveness findings for Narcan (injectable naloxone hydrochloride) to support its application. New indications.

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The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. 1 Study evaluations included efficacy, safety, pharmacokinetics, and pharmacodynamics.

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FDA Approval FDA Treatment Clinical Trials 52

The ChEMBL-og

APRIL 16, 2024

For legacy AUC and Cmax records (< ChEMBL 34), pharmacokinetic parameters have been extracted from the assay descriptions using regular expression matching (RegEx). When possible, AUC record units were converted to ng.hr.mL-1 1 and Cmax record units were converted to nM by creating new conversion rules.

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The Pharma Data

FEBRUARY 12, 2022

Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times. Gilead Lores,Inc.

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The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product.

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Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

APRIL 27, 2021

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. About the Phase 1/2 Trial.

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The Pharma Data

MARCH 16, 2021

TREMFYA q4w is not currently FDA-approved. Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. He has not been compensated for any media work. Clinically meaningful defined as ?3 About DISCOVER-2 (NCT03158285) 14. About Psoriatic Arthritis.

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