While countries bidding to become the new home to the European Medicines Agency (EMA) are excited at the chance its likely relocation from London offers them following Brexit, a group representing the continent’s pharma associations has expressed anxiety at potential disruption the move may cause. 24 April 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended a total of nine new medicines for approval at its April meeting. 22 April 2017
The European Medicines Agency’s management board has adopted a new policy on how the EMA handles allegations of improprieties received from external parties, it was announced today. 10 April 2017
US pharma giant Pfizer has received marketing authorization from the European Commission for its Xeljanz (tofacitinib citrate) 5mg twice daily oral tablets in combination with methotrexate (MTX) for moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. 29 March 2017
As it did in the USA, biotech major Amgen has become the first to gain European Union (EU) approval for a biosimilar version of AbbVie's Humira (adalimumab), the world’s best-selling branded drug. 24 March 2017
The European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias. 1 March 2017
Rare and specialty diseases specialist Mereo BioPharma Group was trading 2% higher on Monday lunchtime at £2.90 after more positive news on an asset which it acquired from Swiss pharma major Novartis in 2015. 20 February 2017
At its meeting this week, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency concluded a safety review and started two new ones. 10 February 2017
Warnings that patients could face delays in accessing new drugs if the UK withdraws from the European Medicines Agency (EMA) as part of the Brexit process have been issued by senior figures in British healthcare. 10 February 2017
Denmark has a high-profile supporter in its bid to become the new home of the European Medicines Agency (EMA) – the diabetes giant Novo Nordisk. 9 February 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. 28 January 2017
AbbVie says its marketing authorization application (MAA) has been validated and is now under accelerated assessment by the European Medicines Agency for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes. 24 January 2017
In December, the UK pharmaceutical industry gave evidence to the Exiting the EU Committee where, though its trade body the Association of the British Pharmaceutical Industry (ABPI), it stated that in the opinion of the UK's £60 billion (~$74 billion) Life Sciences sector, a primary objective for government in Brexit negotiations should be to secure alignment and cooperation with EU medicines regulation. 14 January 2017
Our quarterly Special Report from experts at QuintilesIMS provides scientific and practical insights on Post Authorization Safety Studies based on the first three years since implementation of the new European Union legislation, offering forecasts for likely advances in 2017. 29 December 2016
Belgian biopharma firm TiGenix has submitted its responses to the European Medicines Agency's (EMA) day 120 list of questions for Cx601, its lead product candidate being developed for complex perianal fistulas in Crohn's disease. 23 December 2016
The European Commission (EC) has authorized the extension of the label for all metformin-containing products for all metformin-containing products for the treatment of type 2 diabetes. 21 December 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
USA-based Intercept Pharmaceuticals has won conditional marketing authorization from the European Commission for its liver disease drug Ocaliva (obeticholic acid). 14 December 2016
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 8 December 2016
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Following a positive a positive European Medicines Agency recommendation in July, the European Commission (EC) has now approved Yuvanci (macitentan 10mg and tadalafil 40mg single tablet combination therapy [M/T STCT]). 1 October 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
The European Medicines Agency’s (EMA) safety committee (PRAC) has recommended measures to minimize serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. 7 September 2024
EC approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for urothelial carcinoma in adults. 3 September 2024
Pierre Fabre Laboratories has announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. 30 August 2024
The European Commission has authorized GSK's (LSE: GSK) Arexvy (respiratory syncytial virus vaccine) for preventing lower respiratory tract disease caused by RSV in adults aged 50-59 with underlying health conditions. 30 August 2024
The European Commission (EC) has extended the indications of the antifungal Cresemba (isavuconazole) to pediatric patients, says Swiss drugmaker Basilea Pharmaceutica. 28 August 2024
The European Commission (EC) has approved a Type II extension of indication for Johnson & Johnson’s Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed). 27 August 2024
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
US biotech Regeneron Pharmaceuticals yesterday announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. 27 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) 27 August 2024