Development

ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.

Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.

The clinical trial research environment has evolved because of specific solutions designed to overcome uncertainty.

Preclinical testing is better able to evaluate complex drug candidates thanks to innovations in animal model approaches.

Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

The growth in demand of viral-vector-based gene therapies drives continuous efforts to improve viral vector manufacturing.

Successful scale-up and BLA filings for products manufactured by microbial biomanufacturing require strategic planning.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Promising applications for targeted delivery may be cresting the horizon.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Avoiding roadblocks through strategic planning early on can help facilitate IND application filings.

The recent approvals of bispecific antibodies have opened the gate for the further development of these complex molecules.

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Finding specific solutions to overcome uncertainty has led to the evolution of a new clinical trial research environment.

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.

Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.