Drug Development

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.

Demand for Custom Dosage Forms Fuels Innovation

Controlled-release formulations offer numerous advantages for developers and patients, and this market is expected to continue to experience growth in the near future.

Taking a Controlled Approach

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Can RNA Simplify Gene Therapy Development?

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

FDA approves Roche’s Phesgo, a Fixed-Dose Combination Breast Cancer Drug

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

FDA Issues Complete Response Letter to Allergan, Molecular Partners for Ocular Therapeutic BLA

Feliza Mirasol is the science editor for 

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Analytical Assays Determine Biosimilar Product Quality

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.

Ajinomoto Bio-Pharma Services Introduces Fast-Track Drug Product Manufacturing Platform

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

FDA Gives Guidance on Development of COVID-19 Vaccines

The refurbishment provides enhanced glass melting power, improved glass distribution, and the production of transparent and amber type I glass bottles to meet the increase in demand for glass vials for vaccines and life-saving medicines.

Bormioli Completes Refurbishment of its Glass Furnace

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.

Formulation and Drug Delivery