Covid-19 Update

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine with no supporting clinical trial results.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

Time sure flies, except when you are waiting for something to happen.

Avacta Group has expanded its partnership with Daewoong Pharmaceutical to include Affimer molecules that target viruses, such as coronavirus.

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

An LIMS system enables a COVID-19 testing center for employees at their workplace.

Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

The project will focus on providing a faster route to clinical studies for AstraZeneca’s potential COVID-19 vaccine, AZD1222.

The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.

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.

A strong immune response by patients receiving two doses of AZD1222 vaccine suggests a possible dosing strategy for COVID-19 vaccine.

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.

Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name.

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

The agreement will accelerate production of SiO2’s plastic vials for vaccines and therapeutics for Operation Warp Speed.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.