Syncona Ltd, a prominent investor in the life sciences sector, has announced a significant strategic collaboration through its portfolio company, Autolus Therapeutics plc, with BioNTech SE, a trailblazer in next-generation immunotherapies. This partnership marks a pivotal step towards the commercialization of autologous CAR-T programs, pending regulatory approvals. BioNTech’s investment of $200 million in Autolus’ American […]
German biotechnology company BioNTech has agreed to acquire 100% of the remaining InstaDeep shares for an upfront consideration of around £362 million in cash and its shares following a Series B investment in the latter in January 2022. Under the terms of the agreement, InstaDeep’s stakeholders are entitled to receive additional milestone payments of up […]
Pfizer and BioNTech have received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for children aged six months to four years. The shot is authorized as the third 3-µg dose in the three-dose primary series. Albert Bourla — Pfizer Chairman and CEO said: “This authorization […]
BioNTech revealed plans to launch the construction of a manufacturing plant for mRNA-based vaccines in the African Union mid-next year. The German biotech company said that the new plant is the next step in its efforts for implementing sustainable end-to-end vaccine supply solutions across Africa. In this regard, BioNTech has signed a memorandum of understanding […]
US pharmaceutical giant Pfizer has withdrawn its application for emergency use authorization of its BNT162b2 COVID-19 vaccine in India. This decision comes after a series of interactions with the Indian drug regulator, which had requested additional information regarding the vaccine. Regulatory Hurdles and Safety Concerns Initially submitted for approval in December 2020, the application faced […]
Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the use of the BNT162b2 Covid-19 vaccine from US pharma giant Pfizer and German biotech company BioNTech. The Swiss pharma regulator said that as per the data it has assessed, the level of protection afforded seven days following the second dose of the mRNA vaccine is […]
BNT162b2 FDA EUA : Pfizer and BioNTech have been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for BNT162b2, their Covid-19 mRNA vaccine. BNT162b2 has been authorized by the FDA for its use in the prevention of Covid-19 in individuals aged 16 years or more. Pfizer and BioNTech will look […]
US pharma giant Pfizer and German biotech company BioNTech have bagged Health Canada approval for their BNT162b2 Covid-19 vaccine. The BNT162b2 vaccine has been authorized to be used in Canada under the regulator’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19. Canada has now joined the UK […]
The UK has given a temporary authorization for emergency use for the BNT162b2 Covid-19 vaccine candidate developed by Pfizer and BioNTech. The emergency use authorization (EUA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for the mRNA vaccine candidate follows the release of positive results of a global phase 3 trial. Pfizer and […]
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 […]
