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FDA starts speedy review of Novartis’ sickle cell antibody
Among several $1bn+ late-stage drugs in company's pipeline
AbbVie’s Skyrizi gets rapid ‘yes’ from NICE
New fast-track appraisal a boon for companies
FDA will maintain the pace, vows Woodcock, but warns of skills gap
Top official unconcerned by dip in approval rate
FDA verdict on Sanofi’s Darzalex rival is due in April 2020
One of several anti-CD38 antibodies in pipeline
Trump presses on with reference pricing plan for medicines
Proposed pilot programme to run until 2025
AstraZenca to appeal NICE rejection of Tagrisso
Pfizer’s Vizimpro wins recommendation
NICE backs CDF funding for Sanofi/Regeneron’s skin cancer drug Libtayo
Acknowledges unmet need
ViiV bags EU okay for new two-drug HIV therapy
Rivals Gilead's Biktarvy
Sanofi/Regeneron’s IO latecomer Libtayo approved in Europe
Licensed to treat one of the most commonly diagnosed skin cancers
‘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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Ex-FDA chief Gottlieb's quick move to pharma raises eyebrowsWill join Pfizer board
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CHMP blocks UCB/Amgen’s Evenity approval for osteoporosisAnother obstacle for drug
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FDA clears Dupixent as first-ever drug for chronic rhinosinusitis with nasal polypsCould add $1bn to revenues, say analysts
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FDA fast-tracks Jardiance for heart failure reviewWould challenge Novartis' Entresto
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Charity launches real-world medical cannabis studyEx-government advisor David Nutt involved
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Acer Therapeutics hit by FDA filing rejectionShares plunge as regulator calls for new trial
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Faced with regulator’s merger concerns, BMS want to offload OtezlaSell-off will mean merger delay
Latest regulatory appointments
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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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IFPMA names new communications director
Helen Gallagher joins the association from Ferring Pharmaceuticals
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