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Moderna launches phase 1/2 study of mRNA-based flu vaccine

Vaccine will target flu lineages currently recommended by the World Health Organization

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FDA rejects Provention Bio’s type 1 diabetes prevention drug

FDA said a study of healthy volunteers failed to demonstrate that the planned commercial product is comparable to an older version used in previous clinical trials

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Moderna says its COVID-19 vaccine appears effective against Delta and other variants

Earlier this year, the company revealed early evidence that its booster jabs may be effective against ‘variants of concern’

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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

- 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

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BMS’ Zeposia gains FDA approval in ulcerative colitis

Treatment was initially approved in 2020 for multiple sclerosis

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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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FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy

CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months

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Moderna’s COVID-19 vaccine offers high levels of protection for adolescents

The study results showed a vaccine efficacy of 100% starting 14 days after the second dose

- PMLiVE

FDA approves Apellis’ Empaveli for rare blood disease

PEGASUS study results show Empaveli is better than Soliris at improving haemoglobin levels

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