Pharmaceutical Technology Editors

Johnson & Johnson announces clinical trial plans for COVID-19 vaccine candidate, as well as plans to produce 1 billion vaccine doses.

The joint public-private initiative will provide $4 million in funding to a Johns Hopkins-led research team exploring therapeutic uses of blood plasma from recovered COVID-19 patients.

AzarGen’s biosimilar, made in iBio’s plant-based system, will be compared to the original molecule in pre-clinical studies.

ProBioGen will facilitate the development of Immunogenesis’ monoclonal antibody candidate and will be responsible for manufacturing the drug at its new facility in Berlin, Germany.

The companies will use CytomX’s Probody therapeutic technology platform and its proprietary bispecific formats and CD3 modules.

The company is developing the first humanized antibody that can control the inflammatory response and prevent uncontrolled inflammation connected to the virus.

Data and analytics company GlobalData announced that there is a strain on the global biopharma industry’s supply chain due to the ongoing outbreak of COVID-19.

Prior to the global market downturn, data from the United Kingdom BioIndustry Association (BIA) and Informa Pharma Intelligence have revealed that biotech companies in the UK had raised £309 million (US$379 million).

AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).

Mylan and Pfizer announced a postponement of the transaction that would see Mylan and Upjohn Combined until the second half of the year as a result of the current COVID-19 pandemic.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the latest statement by the members of the European Council on efforts to tackle COVID-19.

AstraZeneca has revealed that it will collaborate with Silence Therapeutics on the discovery, development, and commercialization of small interfering RNA (siRNA) therapeutics for the treatment of cardiovascular, renal, metabolic, and respiratory diseases.

Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.

The strategic alliance provides an integrated product offering around drug discovery and development.

The company has developed mathematical algorithms that generate simple cell-count data from a few days of culture.

The new NAB Nanosep device provides increased binding capacity.

The company has launched new high volume eight- and 12-channel pipettes, offering a capacity of 1250 µL per channel.

The transgenic mouse R&D platform will support the discovery of fully-human monoclonal antibodies.

Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

The company announced the status of new and ongoing clinical trial activities during the COVID-19 pandemic.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

Enhancements to Augury’s AI-based machine health platform include new capabilities and collaboration tools for personnel working remotely.

FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19.

Novartis will donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

In a daily press briefing on March 18, 2020, the World Health Organization (WHO) announced that, along with its partners, it will be organizing a large international study that will compare various untested treatments for COVID-19.

The facility, which handles discovery chemistry services, will accelerate its operations over the next few weeks while taking precautions to guarantee the health and safety of its employees across every site.