Biologic Drugs in Development

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

The company has appointed Liam Tayler as CEO to guide the growth of the company’s iPSC technologies, products, and services.

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

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

Preliminary data from a German Phase I/II trial shows Pfizer/BioNTech COVID-19 vaccine candidate produces immune response.

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.

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.

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 complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

The companies have entered into a development and manufacturing agreement for Anthos Therapeutics’ abelacimab for treating thrombotic disorders.

Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.

CordenPharma announces expansion of lipid excipients supply for coronavirus vaccine scale up.

Agreements with the PolyPeptide Group and AGC Biologics will scale up production of the Novavax Matrix-M adjuvant.

Achieving herd immunity will require testing, data, a vaccine, and public support.

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

CanSinoBIO will license-in Precision NanoSystems' proprietary RNA vaccine platform technology while the latter leads the development of the RNA vaccine formulation.

The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.

Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.

Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.