News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
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.