Formulation and Drug Delivery

EMA Recommends Four Biosimilars for Approval

June 04, 2018

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA Recommends Approval of Migraine Biologic

June 04, 2018

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

Emerging Technologies Advance Oral Drug Delivery

June 02, 2018

New approaches enable more patient-centric drug design that offers improved outcomes.

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.