Drug Development

Articles

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

FDA Committee Recommends Approval of Spark’s Eye-Disease Gene Therapy

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Promethera and Shibuya Partner on New Cell-Therapy Manufacturing Platform

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic

Europe updates the guideline on excipients information in labeling and packaging.

EMA Updates Guidelines on Excipients in Labeling

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

J&J Invests in Biologic Manufacturing Capacity Expansion in Ireland

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

ProBioGen and Chiome in Antibody Manufacturing Deal

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

Compared to traditional drug discovery approaches, drug repurposing, repositioning, and rescue can be faster and cheaper.

Finding a New Purpose for an Unproven Drug

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany. 


Sartorius Stedim Cellca Builds Laboratory and Office Facility in Germany

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

Managing Potentially Potent APIs

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

APIs and Excipients