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Biogen completes filing for highly-anticipated Alzheimer’s drug
FDA has 60 days to decide whether to accept filing for review
Moderna clashes with US scientists over pivotal COVID-19 vaccine trials
Delays allegedly resulting from a lack of cooperation
EU gives AZ’s Lynparza green light for BRCA-mutated pancreatic cancer
PARP inhibitor now available for rare, life-threatening disease
Mesoblast expands compassionate use COVID-19 programme
Will now include children with multisystem inflammatory syndrome
EMA fast-tracks review of AZ/Daiichi Sankyo’s HER2 drug
Antibody drug conjugate gained approval in US in December
Britain closes in on £500m COVID-19 vaccine deal with Sanofi/GSK
Alleged deal could include agreement for 60 million doses
Novo Nordisk gets another OK for oral GLP-1 drug Rybelsus
Drug is first and so far only oral alternative to injectable GLP-1 agonists
New Japanese approvals include first OK for GSK’s anaemia drug Duvroq
And Novartis gets green light for non-small cell lung cancer drug Tabrecta
Novartis pulls EU filing for $3.4bn eye therapy Xiidra
Company says EMA’s concerns “could not be addressed within the available timeframe”
‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’
Brexit means pharma must review its intellectual property rights across Europe
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Moving timesContinuity and stability are vital when it comes to the EMA's relocation when it leaves London
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SMC gives green light for Amgen’s KyprolisThe committee also gives verdict on three other products
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BMS scores EU okay for first-in-class anaemia drug Reblozyl Drug is one of five of Celgene’s late-stage pipeline drugs with blockbuster potential
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Novartis agrees $347m settlement for bribery allegationsSettlements involve bribery schemes in Greece and Vietnam
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Early knockback for AbbVie as FDA rejects Allergan eye drugDrug as effective as rival Novartis’ drug but has more side effects
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CSL licenses uniQure haemophila B gene therapy in $2bn-plus dealCould free patients from the need for regulator injections with clotting factor drugs
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FDA approval for Merck’s Keytruda threatens Libtayo in skin cancerAnother registration trial of Libtayo is due to report in 2021
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EMA starts review of Bavencio in first-line bladder cancerResults from phase 3 study may lead to possible approval next year
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Epidarex closes £102m biotech fund for UK life sciencesAround half of that investment comes from the UK government’s British Business Bank
Latest regulatory appointments
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ABPI appoints industry veteran Richard Torbett as new chief executiveTorbett initially joined the pharma association in March 2016
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Professor Carole Longson moves from NICE to the ABPIShe joins the UK pharma body as its chief scientific officer
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MedTech Europe appoints new board of directors
Chair of the board Michelle Brennan is among those newly elected
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Greg Perry joins IFPMA as assistant director generalWill move to the global industry body from the Medicines Patent Pool
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AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance
He joins the biopharma from Tang Capital Management
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