article thumbnail

Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

article thumbnail

China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

Pharmaceutical Technology

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Pharmaceutical Technology

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

article thumbnail

US to buy additional Novavax Covid-19 vaccine doses

Pharmaceutical Technology

The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373). million additional doses of its Covid-19 vaccine. Under the modified deal, Novavax will deliver up to 1.5

article thumbnail

Genetic Vaccine Development for Infectious Diseases Summit

pharmaphorum

The COVID-19 pandemic brought life-changing disruptions to people around the world and has turned the typical vaccine R&D process on its head. A combination of urgent need, unprecedented investments, and advances in genetic engineering has allowed what was once mere speculation to become not only our reality, but our future.

article thumbnail

Scientists engineer safe, virus-resistant E coli for research

Drug Discovery World

In a step forward for genetic engineering and synthetic biology, US researchers have modified E coli bacteria to be immune to infection by all natural viruses tested so far. Genetic engineering The findings build on earlier efforts by genetic engineers, which involved genetically reprogramming E.

article thumbnail

Novavax and SIPL to Develop 1 Billion COVID-19 Vaccine Doses for India, Other Countries

BioSpace

CoV2373, a recombinant vaccine engineered from the genetic sequence of SARS-CoV-2, in India and in low- and middle-income countries. Novavax said the agreement will allow for the development and distribution of NVX?CoV2373,