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EMA discusses future Amsterdam premises
The EMA Management Board have met in an extraordinary session to discuss EMA’s future premises in Amsterdam...
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European Medicines Agency (EMA)
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Strengthened guidance on follow-up and risk management for ATMP developers
Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation...
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EC grants orphan drug designation for Gilteritinib for the treatment of AML
The European Commission has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia...
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UK Life Sciences firms struggle in post-Brexit war for EU talent
Following the Brexit vote, the UK is already seeing problems in filling senior positions at life sciences companies, with their average “slate” of candidates falling from around 40% non-UK nationals to just 15% non-UK candidates on average...
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Obstacles to success for biosimilars in the US market
Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five. The FDA, however, since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2009,2 has licensed six products under PHS 351(k) of the Public Health Service (PHS) Act; approved one product under…
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The impact of Brexit on life sciences
On 30 March 2019 the UK is set to leave the European Union (EU), a process that has become popularly known as Brexit. One little talked-about aspect of this move in the mainstream media is the impact it will have on the British life science community. Researchers and industry leaders…
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EMA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated NSCLC
The EMA has accepted a variation to the MAAv for Tagrisso, for the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer...
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EMA to relocate to Amsterdam, the Netherlands
The EMA will relocate to Amsterdam in the Netherlands. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest...
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Could Milan be the new home for the EMA?
Wayne Pines, President of Healthcare at APCO Worldwide in Washington DC and a former Associate Commissioner of the FDA believes Milan is a logical choice for the relocation of the European Medicines Agency...
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EMA grants marketing authorisation for Prevymis against cytomegalovirus
10 November 2017 | By
The EMA has recommended granting a marketing authorisation Prevymis, an antiviral medicine that prevents CMV reactivation and disease...
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Sandoz proposed biosimilar pegfilgrastim accepted by EMA
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
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UCB receives EU approval for paediatric anti-epileptic drug
UCB has announced that the EC has approved the use of its anti-epileptic drug Vimpatas in the treatment of partial-onset seizures...
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Experimental treatment for Niemann-Pick disease appears safe
An experimental drug has appeared to slow the progression of Niemann-Pick disease type C1...
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Report identifies two-tier pharmaceuticals market
A report released has identified a two-tier manufacturing market and forecast increased acquisitions by Indian companies...
