The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
Tag Archive for: BioNTech
BioNTech on Monday said the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on an early stage study of its experimental cancer drug.
Losses at German drugmaker BioNTech quadrupled in the second quarter from a year earlier, the company said on Monday, as it banks on a strategy shift towards new cancer treatments following a sharp drop-off in sales of its COVID-19 vaccine.
The COVID-19 vaccine maker’s cancer drug candidate BNT111 showed significant improvement in the response rate in patients with advanced melanoma during a Phase 2 trial, the German company said on Tuesday.
The FDA has slapped a partial clinical hold on BioNTech and MediLink’s Phase I study of an antibody-drug conjugate candidate for types of non-small cell lung cancer or breast cancer, following multiple patient deaths.
As BioNTech struggles to establish its footing in a post-pandemic world, the biotech has secured $145 million from the Coalition for Epidemic Preparedness Innovations to expand its mRNA operations in Rwanda.
In an oral decision, the European patent authority maintained the validity of Moderna’s patent ‘949 which describes and protects specific alterations to mRNA molecules designed to lower its immunogenicity, bypass the immune system and boost its translation in the body—as well as the potential uses of the modified mRNA.
BioNTech, which is investing money earned during the pandemic in cancer drug development, said in a statement that it is still targeting 2024 revenues in a range of 2.5 billion euros ($2.69 billion) to 3.1 billion euros.
Pfizer and BioNTech asked a London court to revoke rival Moderna’s patents over technology key to the development of vaccines for COVID-19, as the latest leg of a global legal battle began on Tuesday.
A federal court in Massachusetts has granted Pfizer and BioNTech’s motion to put on hold Moderna’s lawsuit over alleged patent infringement related to their COVID-19 vaccine Comirnaty.