Covid-19 Update

Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.

Biopharmaceutical companies and federal agencies have been working overtime and assuming considerable risk to be able to supply billions of doses of any safe and effective preventive.

The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic.

The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.

Vibalogics is contracted to manufacture Janssen's COVID-19 candidate vaccine at its GMP-accredited facility in Cuxhaven, Germany.

Leadership was announced for the US government’s Operation Warp Speed program, which aims to deliver COVID-19 vaccines, therapeutics, and diagnostics.

A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions.

The Coalition for Epidemic Preparedness Innovations will invest up to $384 million of additional funding, in addition to the $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.

The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.

A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

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.

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.

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.

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

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

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

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.

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.

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