Drug Development

Articles

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

First Ebola Vaccine Gains Conditional Marketing Authorization Recommendation

CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.

CHMP Recommends EU Marketing Authorization for Baqsimi

Agnes Shanley is senior editor of Pharmaceutical Technology.

Antimicrobial resistance is now the third leading cause of death in the US. As developers continue to leave an unprofitable market, legislation and new reimbursement models propose to stimulate development of new antibiotics.

Restoring the World's Antibiotic Pipeline

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.

Formulation and Drug Delivery