Formulation and Drug Delivery, Biologic Drugs

FDA Issues Guidance on Development of Drugs for Monkeypox

January 23, 2023

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

SuspendIt Anhydrous Introduced as New Compounding Base

January 11, 2023

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

Updated REMS Document for Prescription, Biological Drug Product

January 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

European Commission Approves Spevigo for Generalized Psoriasis Flares

December 13, 2022

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

Reformulating Success

October 02, 2022

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

Accelerating the Development of mRNA Therapeutics

September 16, 2022

Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.

Advances in Drug Delivery and Areas for Improvement

September 02, 2022

While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.

Deciding Where to Outsource in Biopharma Development and Manufacturing

August 02, 2022

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Novo Nordisk Expands Research Collaboration in Novel Delivery Technologies for Biologic Medicines

March 10, 2022

Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

Pfizer and Acuitas Therapeutics Collaborate on Lipid Nanoparticle Delivery System

January 11, 2022

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.