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migraine

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FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

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FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

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FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

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Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

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AbbVie, Biogen and Pfizer collaboration creates new resource for genetic exome sequence analysis

Companies have created 'world’s largest' resource for genetic exome sequence analysis

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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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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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MorphoSys expands oncology pipeline with $1.7bn acquisition of Constellation Pharmaceuticals

MorphoSys has also entered into a long-term strategic funding partnership with Royalty Pharma

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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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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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AZ, Pfizer/BioNTech COVID-19 vaccines ‘highly effective’ against Indian variant

UK study finds vaccines are likely to be effective in preventing hospitalisation/death

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