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- PMLiVE

Otexla

Sanofi reception

Sanofi to invest €400m annually in mRNA vaccines facility

French pharma company will build end-to-end R&D of ‘next-generation’ mRNA vaccines

- PMLiVE

Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

Sanofi reception

Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

- PMLiVE

Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses

Pfizer/BioNTech and AZ vaccines found to be 96% and 92% effective against variant, respectively

- PMLiVE

US to donate 500 million Pfizer/BioNTech COVID-19 vaccine doses through COVAX

As part of the agreement, 500 million doses will be delivered between August 2021 and June 2022

- PMLiVE

FDA approves Biogen’s aducanumab for Alzheimer’s disease in ‘landmark’ decision

FDA is requiring Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients

- PMLiVE

Moderna seeks full FDA approval for its COVID-19 vaccine

Moderna's mRNA-based vaccine is currently authorised for emergency use in the US

- PMLiVE

Israel finds a ‘probable link’ between Pfizer vaccine and myocarditis cases

Reported cases increased following the second dose of the mRNA-based COVID-19 vaccine

- PMLiVE

BMS’ Zeposia gains FDA approval in ulcerative colitis

Treatment was initially approved in 2020 for multiple sclerosis

- PMLiVE

EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

- PMLiVE

FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) narrowly voted in favour of supporting approval of the drug

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