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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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Israel study suggests Pfizer/BioNTech vaccine is less effective against Delta variant

Data suggests vaccine is 64% effective at preventing infection caused by Delta variant after two doses

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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

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Teva reaches $925,000 settlement to resolve drug price-fixing claims

Last year, the US Department of Justice charged Teva for conspiring with competitors in a generic drug price-fixing probe

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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

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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

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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

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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

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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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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

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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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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

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