APIs and Excipients

AbbVie to Acquire TeneoOne and Lead Asset for Multiple Myeloma Treatment

June 25, 2021

AbbVie has exercised its right to acquire TeneoOne, along with its lead immunotherapeutic asset for the potential treatment of multiple myeloma.

Lilly's Investigational Alzheimer's Therapeutic Gets Breakthrough Therapy Designation

June 25, 2021

FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.

SelectImmune and Lonza to Develop Immunotherapeutic Drug Candidate

June 24, 2021

The companies have entered into an agreement to develop processes for a novel immunotherapy protein.

GSK and iTeos Therapeutics Enter mAb Collaboration

June 18, 2021

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.

DFE Pharma Becomes Newest Partner in MMIC Collaboration

June 11, 2021

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

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

June 08, 2021

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.

Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb

June 08, 2021

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

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

June 07, 2021

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

New Biotherapies Push Technological Innovation Forward

June 03, 2021

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

Assessing Risk and Production of Potent Substances

June 03, 2021

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