COVID-19 Update

Amid high expectations for a vaccine, bio/pharma readies capacity, weighs pressures.

The companies provided an update stating that the biologic did not meet a primary endpoint in a Phase III clinical trial when compared with placebo in the treatment of COVID-19 patients.

The companies will collaborate on the production of a novel anti-SARS-CoV-2 immunoadhesin in iBio’s FastPharming manufacturing system.

The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.

Negotiations for a final advance purchase agreement where the Government of Canada purchases the vaccine candidate on a not-for-profit basis for emergency pandemic use are underway.

The vaccine will be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical starting in the first half of 2021 if the vaccine candidate receives regulatory approval.

Novavax and the Government of Canada will finalize an advanced purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning in the second quarter of 2021.

Oxford Biomedica will reserve capacity for AstraZeneca in three of its manufacturing suites in its new commercial manufacturing center, Oxbox, for 18 months.

The new facility, located in Lenexa, KS, will rapidly expand production of viral transport media.

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

Under expanded FDA authorization, Gilead Sciences’ antiviral treatment for COVID-19 can be administered to all hospitalized patients.

How real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.

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.

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

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.

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

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

Catalent will manufacture drug substance for AZD1222 at its Harmans, MD facility.

The Phase II trial is a randomized, placebo-controlled, observer-blinded study that will include patients aged 18 to 84 years.

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.

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

UK government has set up a new organization to replace Public Health England.

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

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 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.

Plastic primary packaging could help prevent supply chain shortages associated with high demand for COVID-19 vaccines.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

SK bioscience will manufacture the vaccine antigen component for use in the final drug product at its vaccine facility in Andong L-house, South Korea.

ANA will use Quotient’s formulation and manufacturing knowledge to develop and supply the drug product for clinical trials by the third quarter of 2020.