All News

Hahn promises transparency in the review and approval of COVID-19 vaccines.

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

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

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.

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.

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

AstraZeneca has dosed the first participants in its Phase I clinical trial assessing the safety, tolerability, and pharmacokinetics of a combination of two monoclonal antibodies (mAbs) for the prevention and treatment of COVID-19.

Müller + Müller will become part of DWK upon closing in September 2020 and will continue to function under the same name and management.

Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency.

Mapp has selected Avid to provide process transfer, scale-up, and clinical manufacturing services for one of its development programs for a novel antiviral drug candidate.

Medical management services provider, Europital, has announced the opening of a new site in Oxford, United Kingdom, in response to demand from small and medium innovators within the biotech industry.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

The contract is valued at $106.3 million and is supported by Operation Warp Speed.

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2.

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

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

Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.

The collaboration will increase the supply of the potential treatment to at least three and a half times the current capacity.

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

Bristol Myers Squibb will handle the development and commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing.

The deal is expected to close during the second half of 2020.

The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase (BTK) inhibitors to add to its portfolio of next-generation transformative treatments for autoimmune diseases.

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.