Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Cambrex has collaborated and partnered with pharmaceutical customers to develop and manufacture FDC drugs that are US FDA-approved and are currently in the various stages of clinical development.

Manufacturing 130

Manufacturing Production Packaging Packaging 130

XTalks

JUNE 14, 2023

Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Saphnelo is also being evaluated for SLE in the European Union and Japan.

Marketing 52

Marketing Sales FDA Approval Antibody 52

Delveinsight

AUGUST 10, 2020

Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Food and Drug Administration approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).

Drugs 52

Drugs Trials Bioavailability FDA Approval 52

The Pharma Data

MARCH 11, 2021

Presentation Title: Preclinical characterization of LY3484356, a novel, potent and orally bioavailable selective estrogen receptor degrader (SERD). FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 Session Date and Time: Monday, April 12, 2021 1:30 PM – 3:15 PM ET.

Research 52

Research Clinical Trials Clinical Trials Trials 52

The Pharma Data

APRIL 11, 2023

Notably, these presentations include new data from dose proportionality and bioequivalence studies, which supported the FDA approval of once-daily AUSTEDO XR extended-release tablets – demonstrating AUSTEDO XR is therapeutically equivalent to the currently marketed twice-daily AUSTEDO. affiliate of Teva Pharmaceutical Industries Ltd.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40

The Pharma Data

DECEMBER 1, 2020

Artificial intelligence holds immense promise to catalyze the development of the next generation of highly selective, orally bioavailable molecules, with reduced side effects, for the most impactful drug targets,” said Evan N. Most recently, Genesis announced a multi-target partnership with Genentech. Feinberg, Ph.D.,

Development 40

Development Drugs Engineer FDA Approval 40

XTalks

AUGUST 30, 2022

A major obstacle for CNS drug developers is the inability to target therapies to the CNS broadly (for instance, a therapy that is orally bioavailable as a pill and has difficulty crossing the blood-brain barrier) and certain CNS regions more specifically. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

SEPTEMBER 19, 2024

It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies. Zanubrutinib has five US Food and Drug Administration (FDA)-approved indications and the broadest label in its class.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

MARCH 24, 2025

Without effective disease-modifying therapies and optimal management strategies, the constant fatigue, swelling and mental health challenges surrounding those living with C3G profoundly disrupt daily life and overall quality of life.

Bioavailability 71

Bioavailability Immune Response Protein Bacteria 71