CoSara Diagnostics has secured clearance from the Indian Central Drugs Standard Control Organization (CDSCO) to manufacture and sell its Saragene COVID-19 2-gene multiplex RT-PCR test. The approval allows the Saragene COVID-19 2-gene multiplex RT-PCR test to be used as an in vitro diagnostic (IVD) in the qualitative detection of the SARS-CoV-2 virus that causes Covid-19. […]
Pfizer and BioNTech announced that the BNT162b2 mRNA-based vaccine candidate has been shown to be more than 90% effective in the prevention of Covid-19 in participants of a phase 3 trial who were not previously exposed to the SARS-CoV-2 infection. The data is based on the first interim efficacy analysis from the phase 3 clinical […]
AstraZeneca said that AZD7442, which is being developed for the prevention and treatment of Covid-19, will move into two phase 3 clinical trials. AZD7442 is a combination of a couple of monoclonal antibodies (mAbs) extracted from convalescent patients with SARS-CoV-2 infection. It will be assessed in more than 6,000 participants at sites in and outside […]
Novavax has initiated its first phase 3 clinical trial to assess the efficacy, safety, and immunogenicity of its NVX-CoV2373 COVID-19 vaccine candidate. The US vaccine development company is carrying out the late-stage trial in the UK in partnership with the UK government’s Vaccines Taskforce. The phase 3 trial of NVX-CoV2373 will aim to enroll and […]
Johnson & Johnson (J&J) said that its subsidiary Janssen Pharmaceutical has agreed to manufacture and supply 100 million doses of its SARS-CoV-2 investigational vaccine Ad26.COV2.S to the US government, in a deal worth more than $1 billion. The Janssen Covid-19 vaccine candidate will be supplied either after approval by the US Food and Drug Administration […]
Novavax has signed an agreement with FUJIFILM Diosynth Biotechnologies (FDB), a US-based contract development and manufacturing organization (CDMO), for the manufacturing of bulk drug substance for NVX-CoV2373, the former’s COVID-19 vaccine candidate. FUJIFILM Diosynth Biotechnologies’ facility in Morrisville, North Carolina has started production of the first batch of NVX-CoV2373. The arrangement between the two firms […]
Pfizer and BioNTech have bagged a $1.95 billion deal with the US government for supplying 100 million doses of their jointly developed BNT162 COVID-19 vaccine candidate. Recently, the two pharma companies were granted the fast track designation from the US Food and Drug Administration (FDA) for BNT162b1 and BNT162b1 vaccines, which are two of the […]
COV001 clinical trial results : AstraZeneca and Oxford University said that interim results from the phase 1/2 COV001 clinical trial showed the ChAdOx1 nCoV-19 vaccine (AZD1222) to be well tolerated besides generating strong responses in all evaluated participants against the COVID-19 causing SARS-CoV-2 virus. The early-stage COVID-19 vaccine trial is being led by Oxford University, […]
Pfizer and BioNTech said that BNT162b1 and BNT162b2, two vaccine candidates developed to give protection against the SARS-CoV-2 virus have been given the fast track designation from the USFood and Drug Administration (FDA). The two vaccine candidates are part of the four investigational vaccine candidates that are being jointly developed by the companies under their […]
Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind COVID-19. According to the US pharma company, the conditional marketing authorization for Veklury was given in the interest of public health because of the coronavirus pandemic […]