The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver. 28 October 2017
On November 20, the question of which country will host the European Medicines Agency post-Brexit will finally be settled, at the European Council’s General Affairs (Art. 50) meeting. 25 October 2017
One year ago, the European Medicines Agency (EMA) became the first regulatory authority to give open access to clinical data submitted by companies in support of their marketing authorization applications. 24 October 2017
European lawmakers are taking action to help the successful development of what are labelled advanced therapy medicinal products (ATMPs), a category of medicines referring to gene therapies, somatic cell therapies and tissue engineered products. 20 October 2017
Germany’s Merck KGaA has announced that US and EU inspectors have given the all clear to its Californian factory for the production of BioReliance viral and gene therapy products. 19 October 2017
The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use. 9 October 2017
Shares in AstraZeneca edged higher in early dealing today, on the news that US regulators have granted its Tagrisso (osimertinib) Breakthrough Therapy designation and its European peer has accepted the marketing application for its Imfinzi (durvalumab). 9 October 2017
At present, two out of three people diagnosed with cancer survive at least five years. Between 1991 and 2011 deaths from cancer have fallen by 21% across the EU5 (UK, France, Germany, Spain and Italy). 6 October 2017
Two companies have been granted approval for the copycat versions of the Teva Pharmaceutical Industries (NYSE: TEVA) multiple sclerosis drug Copaxone (glatiramer acetate) 40mg/mL in Europe. 5 October 2017
In what is something of a criticism of the European Medicines Agency, a research team has found most cancer drugs are approved by the EMA using only surrogate measures which, although indicators, are not strong predictors of survival – whether living longer or feeling better. 5 October 2017
After a number of media leaks regarding the European Medicines Agency’s view of the rival member states’ bids, the agency has published its assessment in full. 4 October 2017
It has not been an uneventful reign for Guido Rasi as executive director of the European Medicines Agency (EMA) since he took over in November 2011, with first his appointment called into question in a saga that saw him stripped of the role and then reinstated, and now the agency facing a disruptive move from its London home due to Brexit. 4 October 2017
The European Commission has approved the marketing authorization of lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. 2 October 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed an update of the European Union label with immediate effect for Tresiba (insulin degludec) to include results from the DEVOTE trial on severe hypoglycemia. 29 September 2017
A group representing the industry that supplies more than 60% of Europe’s medicines has hit out at the low prices being paid for these drugs. 29 September 2017
The European Commission has granted a marketing authorization for Tecentriq (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. 25 September 2017
The European Commission has approved Xermelo (telotristat ethyl) 250mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. 20 September 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 new medicines, including two biosimilars, for approval at its September meeting. 16 September 2017
The race to win approval in a major market for a biosimilar referencing Herceptin (trastuzumab), the world’s joint second-biggest selling cancer drug, has been all but won. 15 September 2017
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