Formulation and Drug Delivery

Let the Learning Commence

June 02, 2018

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

A Novel Amorphous Delivery System to the Skin for Poorly Soluble Actives

June 02, 2018

Drugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.

Lonza to Manufacture TxCell Product

June 01, 2018

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

An Alternative to Pills and Injections: CUREfilm Redefines How Medicines are Delivered and Experienced

June 01, 2018

The CUREfilm technology delivers drugs through a dissolvable strip that can be applied in the oral cavity or onto the skin.

FDA Releases REMS Guidance

May 31, 2018

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

GE and CCRM Partner with DiscGenics on New Cell Therapy

May 30, 2018

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

WHO Vaccinates Against Ebola with Merck & Co.'s Experimental Vaccine

May 30, 2018

World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.

Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing

May 29, 2018

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Novartis Gains EC Approval for Infliximab Biosimilar

May 29, 2018

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Novartis’ AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility

May 25, 2018

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.