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FDA adcomm split on Sanofi’s type 1 diabetes drug
Concerns rose after Zynquista-treated patients showed an eight-fold increase in DKA
Evenity back on track with FDA panel blessing in osteoporosis
US drugs regulator first rejected the drug due to cardiovascular concerns
FDA expecting boom in cell and gene therapies
Pledges clampdown on developers working outside regulations
China approves Ironwood Pharma’s IBS treatment
Coincides with AZ's Mark Mallon taking over as CEO
Industry pleads for compromise after Brexit defeat
Prime Minister is more boxed in than ever, but unlikely to be toppled
Crunch time as Brexit deal faces ‘meaningful vote’
Rejecting the deal would either result in a no deal or no Brexit, warns May
FDA moves into crisis mode as shutdown drags on
New drug appraisals already being affected
Global ban on pharma freebies, including cultural gifts
New rules cover mooncakes and bereavement payments
Time running out for ‘no-deal’ Brexit medicines laws
Needs parliament clearance before 29 March
‘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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US government shutdown leaves FDA running on emptyFunding row means shutdown could break 21 day record
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NICE rejects Novartis migraine treatment Aimovig A draft 'no' to first-in-class treatment, despite discount
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Novartis gets breakthrough tag from FDA for sickle cell drugLatest pipeline therapy for painful blood disorder
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AstraZeneca wins NICE backing for asthma injectionNICE hails 'competitive pharma market'
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Orphan drugs dominate FDA's record-breaking year
Gottlieb also promises to speed biosimilars and cell and gene therapies in 2019
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Chugai gains FDA breakthrough status for rare CNS treatment
Adds to company's BTD roll-call
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Business warning as talk of Brexit ‘No deal’ grows'Managed no deal' plan is 'not a credible position' warns business
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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- Europe closer to biosimilar rule change, despite fierce resistance from pharma
- FDA expecting boom in cell and gene therapies
- Moving annual total (MAT)
- AZ’s Sean Bohen to exit after business overhaul; report
- FDA moves into crisis mode as shutdown drags on
- Lucid Group prepare for a transformative year with the appointment of a new Director of Corporate Development
- NHS regional footprints
- Not another weight-loss ad
- GENERATION Z IS FEARFUL FOR THE FUTURE OF UK HEALTH SERVICES, SAYS NEW REPORT
- UK businesses leaning towards second Brexit vote
- Meet Porterhouse Medical at the ISMPP EU meeting 2019 in London 22 - 23 January
- Immunomedics craters after FDA rejects breast cancer ADC
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