Development

Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.

The collaboration includes an integrated program that encompasses formulation development, drug substances, and drug product manufacturing.

The register supports cross-functional teams of chemists and biologists in developing non-natural, chemically-modified therapeutics for drug discovery.

AbCellera’s recent acquisition of the OrthoMab bispecific platform is expected to accelerate antibody product development.

Avacta Group has expanded its drug development partnership with LG Chem Life Sciences to include new programs incorporating Avacta’s Affimer XT technology.

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

PPD announced it will provide drug development services to advance Pfizer’s portfolio.

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

Innovate UK has awarded Epsilogen with further grant funding for the development of the next generation antibody treatments for ovarian cancer.

GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.

Strong immune response by patients receiving two doses of vaccine suggests a possible treatment strategy.

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Through the deal, Roche will gain co-commercialization rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of RET-altered non-small cell lung cancer, medullary thyroid cancer, and other types of thyroid cancer

VAR2 Pharmaceuticals has been selected for its development of a drug-conjugated malaria protein that potentially selectively binds to most human tumor types.

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

GlaxoSmithKline (GSK) and Medicago have announced a collaboration for the development and evaluation of a COVID-19 vaccine candidate.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.