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NICE knocks back AstraZeneca's Tagrisso again
Failed to convince the appeal panel of failings in original decision
FDA fast-tracks GSK’s anti-BCMA drug for multiple myeloma
If approved will become first BCMA targeting drug for myeloma
FDA approves Horizon's thyroid eye disease drug ahead of schedule
First FDA-approved treatment for rare autoimmune condition
UPDATED: J&J's $8bn Risperdal judgment reduced to $6.8m
Company will still appeal reduced verdict
EU grants conditional approval to Roche's lymphoma drug Polivy
Drug demonstrated a 40% complete response rate in trial
Novartis gets EU approval for multiple sclerosis therapy Mayzent
Offers subgroup of patients an important new treatment option
J&J wins another label expansion for Darzalex in Europe
Multiple myeloma treatment indicated for early use
J&J pushes to expand Imbruvica label after clinical success
Eyes the frontline setting in chronic lymphocytic leukaemia
FDA delays decision on Intercept's NASH drug by three months
Action date pushed back to 26 June
‘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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FDA committee rejects Intellipharmaceutics’ opioid drug AximrisVerdict closely follows rejection of Nektar’s opioid analgesic
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NICE leaves the ‘the NHS door’ open despite rejecting Bayer’s VitrakviInitial guidance says drug is too costly but encourages further data
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Novo Nordisk gets MACE prevention claim for Ozempic in USKey product for the future growth of Novo's diabetes franchise
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FDA starts priority review of BMS Opdivo/Yervoy in first-line NSCLCA verdict is expected to be delivered by 15 May
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Clovis leapfrogs PARP rivals, filing Rubraca for prostate cancerIf approved would become first targeted therapy for tumour type
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Nektar’s opioid analgesic slammed with FDA panel rejectionPanelists unanimously rejected use of the chronic back pain drug
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NICE recommends Ibrance and Lynparza, rejects Keytruda and Xospata
Cost-effectiveness watchdog issues a round of draft and final guidance
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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- Moving annual total (MAT)
- Novo Nordisk gets MACE prevention claim for Ozempic in US
- NantKwest rockets on promising pancreatic cancer data
- Clovis leapfrogs PARP rivals, filing Rubraca for prostate cancer
- FDA delays decision on Intercept's NASH drug by three months
- Immuno-oncology, personalised medicine continues to drive pharma sector
- Roche’s SMA treatment risdiplam hits another clinical target
- Allergan keeps Linzess generics out until 2029 with Teva settlement
- NICE knocks back AstraZeneca's Tagrisso again
- QiC Dermatology is now open for entry
- The digital shift in pharma marketing
- Lucid Group names Neil Flash chief commercial officer
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