COVID-19 Update

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.

The lab is expected to open in April 2020 and will increase the company’s capacity for diagnostic testing of rare genetic diseases along with its COVID-19 capabilities.

Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

The company is advancing its lung-selective nebulized Janus kinase inhibitor into clinical development to determine its ability to prevent acute lung injury in patients with COVID-19.

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

The drug discovery platform was developed to rapidly predict blocking of COVID-19 pneumocyte cellular entry.

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.

The partnership, led by Takeda and CSL Behring, will focus on developing a hyperimmune immunoglobulin against COVID-19.

The digital event, called Bio Digital 2020, will now take place from June 8–12, 2020.

The companies will collaborate on research and development solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.

The medical service volunteer programs will allow their employees who are licensed medical professionals to help fight against COVID-19 while maintaining their base pay.

N4 Pharma will be undertaking a proof-of-concept research project using a COVID-19 DNA plasmid to demonstrate the ability of its delivery system, Nuvec, to collaborative partners developing DNA or RNA vaccines.

The companies are entering into a partnership to develop fully human neutralizing antibodies targeting SARS-CoV-2 to prevent or treat COVID-19.

The event, which was originally scheduled for May 11–13, 2020 at the Gaylord Palms Resort and Convention Center in Kissimmee, FL, will be canceled due to concerns regarding the spread of COVID-19.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

The patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuels the assembly of natural interferon to overpower the virus.

As the coronavirus pandemic unfolds, the bio/pharma industry must practice science over hype.

The company is currently seeking interest from companies who have the skill and means to rapidly advance BOLD-100 for the treatment of COVID-19.

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.