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Novartis withdraws EU filing for canakinumab
Further setback for cardiovascular blockbuster potential
NICE appraisal fees to be introduced despite opposition
Concessions made for small companies
‘No deal’ Brexit could see pharmacists take lead amid drug shortages
Government steps up preparations as Brexit day nears
FDA clears Sandoz and Pear’s Opioid Use Disorder app
The app incorporates CBT to improve high relapse rates
As May delays, industry warns again of ‘no-deal’ Brexit
Brussels offers warm words, but no renegotiation
FDA fast tracks Novartis’ SMA gene therapy
Gene therapy could be approved in first half of 2019, will challenge Biogen's Spinraza
NICE U-turn sees Opdivo backed as adjuvant therapy for skin cancer
But it is only available via the CDF for now
Shire’s angioedema drug Takhzyro claims EU approval
Approval shortly follows a green light in the US
‘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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MSD claims EU approval for two HIV productsCompany battles back against dominant Gilead and GSK
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Medical devices probe uncovers need for “drastic regulatory changes”Report uncovers lax European regulatory system for medical devices
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Loxo, Bayer get FDA okay for biomarker-driven cancer drugA first for Loxo, and a second mutation-based targeted drug
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Zafgen shares tumble after FDA places hold on diabetes trialRegulator concerns based on deaths with previous drug
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Novartis gets EU nod for Luxturna gene therapyApproval comes almost a year after it was secured a green light in the US
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EU27 backs Brexit terms – now the hard part starts for MayHouse of Commons looks set to oppose the deal
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New ‘voluntary’ UK pricing deal caps growth, but promises faster uptakeDecades old PPRS name to go
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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