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Kite wins FDA approval for blood cancer drug Yescarta
Becomes the first CAR-T therapy approved in the US for B-cell lymphoma
AZ and MSD win FDA priority review for Lynparza in breast cancer
Could become the first PARP inhibitor to be approved in the US for the disease
CHMP recommends Teva's generic version of Astellas' Advagraf
Committee backs the drug for transplant rejection prophylaxis
NICE backs Pfizer’s Xeljanz for RA
But UK’s cost-effectiveness watchdog removes two drugs from CDF
SMC backtracks on Janssen’s multiple myeloma treatment Darzalex
Will now recommend the first-in-class treatment after securing a discount
AZ starts pursuit of lung cancer indication for Imfinzi
And its EGFR inhibitor Tagrisso picks up US breakthrough status
EMA sets aside £32m for temporary staff to help with Brexit move
As agency warns current tender system needs to be updated
AAA’s orphan drug Lutathera wins EU green light
The first-in-class drug treats adults with GEP-NET
FDA grants orphan drug status to UniQure’s Huntington’s Disease treatment
Becomes first investigational gene therapy to receive ODD for the disease
Moving times
Continuity 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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Facing the new wave of biosimilarsDon’t drown out the patient voice, says advocacy group
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Europe’s cancer drug regulation is ‘broken’, claims studySuggests EMA oncology approvals could lead to wasted funds and patient harm
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US court lifts ban on sales of Sanofi's PraluentThe duo can continue to compete against Amgen's rival PCSK9 Repatha
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Teva faces early rival to longer-acting Copaxone in USUS regulator approves Mylan’s MS drug
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ABPI bid to overturn NICE’s budget impact rules failsOne in five new medicines would have been affected by the rejected policy
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Hard Brexit could cost UK healthcare sector £2bn per yearPharma and medical supply firms may face 10% revenue drop
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NICE backs Sanofi's Kevzara for routine NHS use Recommends the RA treatment in combination with methotrexate
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Janssen's Imbruvica fails to win NICE backing in lymphomaBut the agency recommends it on the CDF for another type of cancer
Latest regulatory appointments
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Dr Paula Salmikangas joins NDA GroupMoves to the regulatory affairs consultancy from the Finnish Medicines Agency
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NDA Group appoints new vice president Dr Werner Van den Eynde will also lead its advisory board
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Dr Desiree Luthman joins Verona PharmaShe takes up its vice president position
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IFPMA appoints Fumie Griego as assistant director generalShe joins the global pharma association from Merck KGaA
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Ergomed appoints CEO of PrimeVigilanceDr Jan Petracek to drive pharmacoviglance business
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- Over two thirds of UK residents don’t believe that the state will be able to provide for their healthcare needs in later life
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- Kite wins FDA approval for blood cancer drug Yescarta
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