Coronaviruses
Regulatory Affairs Professionals Society's Michael Mezher presents Regulatory Reconnaissance, a daily news and intelligence briefing that explores the latest developments in the regulatory affairs space. With a focus on COVID-19, the briefing touches on various topics including human testing of inhaled Remdesivir, FDA rejections, clinical trials, and vaccine
Coronaviruses
Leading pharmaceutical companies, including AstraZeneca, Pfizer, and Moderna, are in a race to develop an effective vaccine against the novel coronavirus. Meanwhile, traditional Ayurvedic medicine companies like Patanjali are also claiming to have developed a cure for Covid-19. As the global pandemic continues to spread, the world waits with bated
Coronaviruses
The Russian Ministry of Defense has completed preparations for the start of clinical trials of a Russian vaccine against COVID-19 infection. In the coming days, the first group of volunteers will be vaccinated to study the safety and tolerability of the vaccine components. This group will undergo a two-week isolation
COVID-19
The ImmuneCODE initiative, a collaboration between Adaptive Biotechnologies and Microsoft, aims to provide a detailed population-level view into the adaptive immune response to the COVID-19 virus. By de-identifying patient samples from around the world, researchers can analyze the T cell response to the virus, potentially leading to the development of
Coronaviruses
Cancer researchers at the Children's Hospital of Philadelphia (CHOP) have developed a strategy to identify protein sequences to target in SARS-CoV-2, the virus that causes coronavirus. By adapting computational tools developed for identifying unique aspects of childhood cancers, the team believes a resulting vaccine would provide protection across
Coronaviruses
Cancer researchers at Children's Hospital of Philadelphia (CHOP) have made a breakthrough in developing a COVID-19 vaccine by identifying regions of the novel coronavirus, SARS-CoV-2, to target. Building on the tools used for cancer immunotherapies, the team has developed a strategy to stimulate an immune response against the
COVID-19
Corning Incorporated has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to receive $204 million to expand its domestic manufacturing capacity of Corning Valor Glass vials, which will support the vaccination and treatment of billions of patients. This investment will enable Corning to accelerate the scale-up of
Vaccines
The development of vaccines against COVID-19 has been a major focus in the scientific community, with several groups working on various approaches. Two companies, Moderna and BioNTech, are taking a novel approach by administering messenger RNA (mRNA) directly to patients, which encodes viral antigens. This approach has been made possible
Vaccines
As the United States continues to grapple with the ongoing coronavirus crisis, congressional Democrats are pushing for greater transparency on research contracts between the government and private companies. Chairwoman of the House Oversight and Reform Committee, Rep. Carolyn B. Maloney, alongside Rep. James E. Clyburn, Chairman of the Select Subcommittee
Vaccines
Novavax, Inc., a late-stage biotechnology company, has announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX CoV2373. This trial is a significant step towards addressing the need for a vaccine in the fight against the global COVID-19 pandemic. The
Vaccines
Novavax, a biotechnology company, has announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX-CoV2373. The trial, conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), aims to evaluate the safety and immunogenicity of the vaccine in approximately
Vaccines
Congressional leaders from the Black Caucus have issued a statement and letter to the National Institute of Health (NIH), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) Secretary Alex Azar, urging them to ensure diverse participation in COVID-19 vaccine trials. The leaders express concern that
