COVID-19 Update

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.

Fujifilm allocates production volumes for COVID-19 treatments in 2021 at its Denmark facility.

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.

Policy makers seek to ensure supplies of new therapies and to limit shortages.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

ILC Therapeutics, a biotech company based in the United Kingdom, has discovered two separate novel treatments for patients suffering with COVID-19 prior to needing ventilators.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

The event will be rescheduled for April 20–22, 2021 at the Javits Center in New York City.

The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

The companies will work to accelerate the development of CytoAgents’ lead COVID-19 drug candidate, GP168, into human clinical trials.

Merck will provide funding and will work with researchers at the Institute for Systems Biology to identify targets for therapeutic intervention and vaccine development.

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

Bayer will provide CAD $1.5 million (USD$1 million) toward two studies to evaluate its chloroquine and interferon beta-1b combination therapies.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

The phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the live biotherapeutic in 90 individuals with COVID-19 symptoms.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

The Commission of Human Medicines Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.