A New Drug Application has been filed with the US Food and Drug Administration for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes. 5 December 2016
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the three main economic objectives of a strategy on what more can be done to support growth, reinforce economic convergence, create jobs and strengthen social fairness in European Union (EU) countries. 28 November 2016
A Marketing Authorization Application (MAA) to the European Medicines Agency, seeking approval for a candidate shingles vaccine, for the prevention of herpes zoster (shingles) in people aged 50 years or over, has been submitted. 26 November 2016
US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) – one of the major players in the emerging immune-oncology space – scored another hit this week as it became the first and only programmed death-1 (PD-1) inhibitor approved for a hematologic malignancy in the European Union (EU). 23 November 2016
Guido Rasi, executive director of the European Medicines Agency (EMA), has seen some huge steps being taken by the regulator since he first took on the role in 2011. 21 November 2016
The European Medicines Agency has granted its PRIority MEdicines (PRIME) designation to SAGE-547 for the treatment of postpartum depression (PPD). 17 November 2016
The European Medicines Agency, in cooperation with the European Commission and the Member States of the European Union, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. 15 November 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) completed its scientific assessment of the annual renewal of the conditional marketing authorization for Translarna (ataluren) and recommended that this be renewed. 12 November 2016
US pharma major Eli Lilly has received conditional marketing authorization in Europe for Lartruvo (olaratumab injection, 10 mg/mL) in combination with doxorubicin, for advanced soft tissue sarcoma (STS). 11 November 2016
A plea has been made to Liam Fox, the UK’s Secretary of State for International Trade, calling on him to clarify what relationship the UK will have with the European Medicines Agency (EMA) as the government presses on with its plans for Brexit. 8 November 2016
US drugmaker Vertex Pharmaceuticals announced the results of a Phase III study of its cystic fibrosis drug, which it said will form the basis for a marketing application in Europe. 8 November 2016
The European Medicines Agency (EMA) has accepted for review Mylan’s regulatory submission its version of diabetes treatment insulin glargine, referencing Lantus, the original product from France’s Sanofi. 4 November 2016
UK-based Mundipharma International has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the opioid overdose reversal treatment Nyxoid (intranasal naloxone spray). 2 November 2016
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC). 31 October 2016
Trade group Pharma Industry Finland (PIF) is warmly in favor of Member of Parliament Annika Saarikko’s proposal to move the European Medicines Agency (EMA) to Finland. 30 October 2016
Ireland-headquartered Shire has been granted EU marketing authorization for pancreatic cancer drug Onivyde (pegylated liposomal hydrochloride trihydrate), it has been announced 18 October 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new branded medicines for approval at its October 10-13 meeting. 14 October 2016
At its October 6, 2016 meeting in London, the European Medicines Agency’s management board elected Grzegorz Cessak as vice chairman for a three-year period. Dr Cessak is president of Poland’s Office for registration of Medicinal Products, Medical Devices and Biocidal Products, a post he has held since July 2009. 8 October 2016
UK-based Mundipharma International and Swedish drug developer Orexo have announced a European Union regulatory submission for the opioid dependence drug Zubsolv (buprenorphine and naloxone). 4 October 2016
South Korean drug developer Samsung Bioepis is closer to bring another biosimilar to the European market – this time referencing the breast and gastric cancer drug Herceptin (trastuzumab). 4 October 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