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Merck claims first-ever okay for Ebola vaccine, in Europe
Comes shortly after J&J filed its Ebola candidate with EMA
BMS scores FDA priority review for Opdivo/Yervoy combo in liver cancer
Possible new treatment for difficult to treat cancer type
NICE backs first cannabis-based drugs, both from GW Pharma
Approved to treat patients with epilepsy and multiple sclerosis
J&J catches up to Merck, files Ebola vaccine in Europe
Company is also in discussion with the FDA in the US to support regulatory filings
Sandoz finally wins FDA approval for Neulasta biosimilar
Follows a three year wait since initial rejection in 2016
Sanofi/Regeneron wins another EU approval for Dupixent
Becomes first biologic approved in EU for CRSwNP indication
US, EU regulators start review of Roche’s Soliris rival satralizumab
Sets up a possible market clash with Alexion next year
Another day, another Brexit delay – so what happens now?
Health Secretary Matt Hancock maintains UK will retain regulatory collaboration with EMA
Astellas stays ahead of its FLT3 rivals with EU nod for Xospata
Approval comes after an accelerated review of the drug
‘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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NICE considering re-evaluation of quality of life assessment Will address concerns around the watchdog's methodologies
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Vertex, NHS England and NICE finally reach agreement for Orkambi Deal also includes Vertex’s other licensed cystic fibrosis medicines
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GSK gets FDA okay for wider use of PARP drug ZejulaNew approval should help it gain some ground from AZ's rival Lynparza
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UPDATED: Ohio opioid trial averted by last-minute settlementDrug manufacturers reach settlement hours before trial set to begin
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Janssen files Tremfya for psoriatic arthritis in EuropeHopes to extend use beyond plaque psoriasis
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Biogen and Eisai revive abandoned aducanumab in shock turnaround Companies plan to file the deserted Alzheimer’s drug with FDA
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Vertex scores FDA approval for CF triple therapy Trikafta Decision comes only a few months after therapy was filed
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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- Moving annual total (MAT)
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- Key success factor (KSF)
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- Merck claims first-ever okay for Ebola vaccine, in Europe
- UK biotech Evgen craters on failed stroke trial
- BMS scores FDA priority review for Opdivo/Yervoy combo in liver cancer
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