news
Blood pressure and heart medication recalled by MHRA in UK
The MHRA have announced another sartan-containing drug product over fears that it is contaminated with the carcinogen N‑nitrosodiethylamine...
List view / Grid view
European Medicines Agency (EMA)
news
Five more countries to join EMA-FDA mutual recognition
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...
news
EMA recommends authorisation to Amglidia for neonatal diabetes
Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children...
news
NICE approves Lenvima for differentiated thyroid cancer
NICE has issued its final appraisal decision recommending reimbursement of Lenvima for the treatment of progressive, locally advanced or metastatic, differentiated thyroid carcinoma...
news
EMA discusses future Amsterdam premises
The EMA Management Board have met in an extraordinary session to discuss EMA’s future premises in Amsterdam...
news
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...
news
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...
news
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...
article
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Since 2007, the EMA has approved 31 biosimilar products1 and refused or withdrawn around five.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…
article
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…
news
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...
news
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...
news
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...
news
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...
news
Sandoz proposed biosimilar pegfilgrastim accepted by EMA
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
