FDA Approval, Packaging and Pharmacokinetics

Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). In 2023, the FDA approved a 2.7 In 2023, the FDA approved a 2.7

FDA Approval

FDA Approval Pharmacokinetics Packaging FDA

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

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.

Release of ChEMBL 33

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: (..)

FDA Approval

FDA Approval Pharmacokinetics International Production

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

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.

Drugs

Drugs Clinical Pharmacology Packaging Small Molecule

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

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.

FDA

FDA Pharmacokinetics Laboratories FDA Approval

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

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).

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

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.

Production

Production Trials Treatment Disease

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV. . Please see full Prescribing Information for more details.

FDA Approval

FDA Approval Treatment RNA FDA

ChEMBL 34 is out!

The ChEMBL-og

APRIL 16, 2024

A significant effort has been made to correctly map the drug form of the EMA data by manually inspecting different EMA sources of information, such as the Product Information (Annex I: Summary of Product Characteristics and Annex III: Labelling and Package Leaflet) and/or Assessment Report, where available. University of Dundee: T.

Clinical Trials

Clinical Trials FDA Cell Based Assays Compound Screening

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

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.

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. Nature Biotechnology. Ricciardi M.J. Science Translational Medicine. Gene Therapy. Press release.

DNA

DNA RNA Engineering Licensing

Rezafungin

New Drug Approvals

MAY 14, 2025

5] Rezafungin was approved for medical use in the United States in March 2023, [1] [6] [5] and in the European Union in December 2023. [2] 7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] Food and Drug Administration (FDA).

Pharmacokinetics

Pharmacokinetics FDA FDA Approval Treatment

Trospium chloride

New Drug Approvals

APRIL 27, 2025

9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15]

FDA Approval

FDA Approval FDA Pharmacokinetics Licensing

Sulbactam

New Drug Approvals

MAY 22, 2025

4] The co-packaged combination sulbactam/durlobactam was approved for medical use in the United States in May 2023. [5] Retrieved 25 May 2023. ^ “Sulperazon” drugs.com. ^ “FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria” U.S. 46 (31): 89808987. 24 May 2023.

Pharmacokinetics

Pharmacokinetics FDA Production FDA Approval

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Drug Discovery Digest

Limited Evidence for Nalfmefene

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

Trending Sources

Release of ChEMBL 33

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

ChEMBL 34 is out!

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

Codon Digest: Injected Gene Editors

Rezafungin

Trospium chloride

Sulbactam

Making a “Miracle” HIV Medicine

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