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Roche, AbbVie hit by clinical hold for Venclexta in myeloma
Safety concerns could hit blockbuster expectations
Keytruda adds another NSCLC approval in Europe
Squamous NSCLC completes first-line dominance
CHMP recommends new Keytruda dosing schedule
Will apply to eight indications across five tumour types
Roche gets EU nod for much-expanded Hemlibra label
Drug is now suitable for all age groups with multiple dosing options
More Brexit chaos as government suffers more defeats
UK parliament rejects a no-deal Brexit
NICE partially clears Darzalex combo in blood cancer
Approved in second-line use under CDF
Brexit deal defeated again, crucial no-deal vote awaits
UK pharma urges no-deal to be ruled out
Trump budget targets rebates, out-of-pocket costs
Biotech sector welcomes end to rebates, but worries about Medicare cuts
23andMe to offer type 2 diabetes testing kit
New report is powered by data from the company’s customers
‘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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Tecentriq gains first IO approval in triple negative breast cancerA coup for Roche in IO field dominated by Keytruda
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Tecentriq combo gains European NSCLC approvalTriple combination approved after targeted therapy
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J&J’s Spravato breaks depression drought at FDAThe esketamine nasal spray is the first new-mechanism antidepressant to be licensed in decades
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FDA chief Scott Gottlieb to step downWon admiration of industry and public health experts
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AbbVie and Boehringer’s psoriasis drug Skyrizi gets CHMP nod Analysts say the drug could be a best-in-class candidate in the therapy area
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EMA could follow FDA’s Xeljanz blood clot warningEuropean agency in step with FDA after safety doubts
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FDA starts review of Biogen’s Tecfidera follow-up for MSIt was initally submitted towards the end of 2018 but had been delayed by US gov shutdown
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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