Drug Development

Articles

GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.

GSK and iTeos Therapeutics Enter mAb Collaboration

CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

DFE Pharma Becomes Newest Partner in MMIC Collaboration

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for NASH Treatment

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

Feliza Mirasol is the science editor for 

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

New Biotherapies Push Technological Innovation Forward

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

In addition to ADCs, other types of highly potent biologics require specialized manufacturing skills.

Assessing Risk and Production of Potent Substances

Sandoz plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

Sandoz to Expand Production Capabilities to Strengthen its European Antibiotics Manufacturing Network

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

Colorcon to Expand its Technical Capabilities with New Containment Suite at its Pennsylvania Headquarters

The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space. 

APIs and Excipients