COVID-19 Update

CordenPharma and Moderna extended a strategic manufacturing services agreement for the supply of lipid excipients to be used in Moderna’s vaccine against SARS-CoV-2.

Advent manufactured the vaccine doses for the Phase 2/3 clinical trial.

A network-based supply chain approach has the potential to improve resilience and performance.

The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.

The company announced that participants have enrolled in a Phase 1/2 clinical trial of its COVID-19 vaccine candidate, NVX‑CoV2373, a prefusion protein made using Novavax’s proprietary nanoparticle technology.

Funding from the US government could lead to 300 million coronavirus vaccine doses by October 2020.

The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.

CanSinoBIO will license-in Precision NanoSystems' proprietary RNA vaccine platform technology while the latter leads the development of the RNA vaccine formulation.

The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.

US manufacturers focus on preparing capacity while vaccines and treatments for COVID-19 are being developed and tested.

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

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

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 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.

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.

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

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.

Under the terms of the agreement, Catalent will develop a powder-in-capsule formulation of Ennaid’s ENU200 program at its site in San Diego, CA.

Through the agreement, Mylan will manufacture and distribute remdesivir in 127 low- and middle-income countries, including India.

In light of the current social distances measures, in place as a result of COVID-19, IMA Digital, part of IMA Group, has been providing virtual experiences for those interested in packaging and processing.

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 companies have entered into a partnership to produce hydroxychloroquine, a treatment currently under investigation for COVID-19.

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

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.

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.

Human cells form the source material for cell therapies and they require a variety of assays to detect bacterial, fungal, and viral contaminants.

Conventional cleaning methods can risk product loss of biologics, prompting biopharmaceutical manufacturers to seek alternative criteria to validate cleaning processes.