Development

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.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.

GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.

Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Orbit Discovery has been awarded the Innovate UK Grant to expand high throughput cell-based functional screening platform capabilities in peptide drug discovery.

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.