Drug Development

Articles

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

FDA Breaks Generic Drug Approval Record

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

A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.

Formulation and Development Considerations for Biologics

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

Improving the Patient Experience with High Viscosity/High Volume Drugs

On Wednesday Nov. 6, 2019, Gregor Deutschle and Dr. Nicolas Eon, both from Schott, will share insights into ready-to-use solutions for complex biotech drugs.


Insights into Ready-to-Use Packaging Solutions for Injectables

The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.

FDA Develops Candidate Vaccine Viruses

AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).

FDA Approves AstraZeneca Asthma Drug in Auto-Injector Pen

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

Novo Nordisk, bluebird bio Partner to Develop Genetic Disease Therapeutics

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization. 

UK Collaboration Uses a Direct Compression Digital Twin to Speed OSD Formulation

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

Lonza, Prevail Therapeutics Partner on Novel AAV9 Gene Therapy Programs

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval. 

Formulation and Drug Delivery