Biologic Drugs

In the study, GigaGen presents a novel technology for producing a new class of drug, recombinant hyperimmunes, that may potentially generate new COVID-19 therapies.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

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

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

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.

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.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

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.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Inovio received a $71-million contract from the US Department of Defense to scale up manufacture of its Cellectra smart device to deliver its DNA vaccine.

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.

The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.

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

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

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

The acquisition gives Novovax an annual operating capacity of more that one billion doses of COVID-19 vaccine antigen.

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

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

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

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

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.