Pfizer and BioNTech’s COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses in adolescents aged 12-15 years old, according to results from a Phase 3 trial released this week. “We plan to submit these data to the FDA as a proposed amendment...
Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
COVID-19 mRNA vaccines are ‘highly effective’ in producing antibodies against SARS-CoV-2 in pregnant and lactating women; and also confer protective immunity to newborns, according to a new study.
GSK will help manufacture up to 60 million doses of Novavax’s COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.
The EU has approved new storage conditions for Pfizer/BioNTech’s vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.
Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents.
J&J will supply the African Vaccine Acquisition Trust (AVAT) with up to 220 million doses of its single-shot vaccine, with the potential to increase the order to a total of 400 million.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
The European Medicines Agency (EMA) concludes that Celltrion’s monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.
Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
As tensions over COVID-19 vaccine supplies in Europe continue, AstraZeneca clarifies that a set of doses at its Anagni plant in Italy are destined for the EU and COVAX.
AstraZeneca has released the primary analysis from its COVID-19 vaccine US Phase 3 trial, showing 76% efficacy for the vaccine against symptomatic COVID-19. The company highlights that this backs efficacy data from Monday's interim analysis, responding...
