Development

Articles

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

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

Biologics Facilities Expand and Establish New  Locations in 2021

This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials.

Vyant Bio, Ordaōs Bio, and Cellaria, Collaborate on Biomarker-Specific Small Protein Therapeutics

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

GSK Gets EC and FDA Approval for Endometrial Cancer Biologic, Jemperli

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

Nanoform, Herantis Collaborate on Nasal Drug Delivery to the Brain of Biologics

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

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