Covid-19 Update

The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

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.

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.

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.

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.

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

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.

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

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.

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.

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.

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 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.

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

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.