The European regulator has accepted a submission from Tokyo’s Astellas Pharma for roxadustat, for the treatment of anemia in adults with chronic kidney disease (CKD). 21 May 2020
Indian company Biocon has received the certificate of good manufacturing practice (GMP) compliance from the European Medicines Agency (EMA) for the manufacture of biologics drug substance (DS) and drug product (DP) at its Bengaluru site. 20 May 2020
AveXis today announced the European Commission (EC) granted conditional approval for Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene. 19 May 2020
The European Commission (EC) has extended the current conditional marketing authorization of Adcetris (brentuximab vedotin) to include adults with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with cyclophosphamide, doxorubicin, prednisone (CDP). 14 May 2020
The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) has recommended expanding the compassionate use of Gilead Sciences’ remdesivir so that more patients with severe COVID 19 can be treated. 13 May 2020
The European Medicines Agency’s advisory committee in February, the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). 11 May 2020
The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), to include people with hyperkalemia on stable hemodialysis. 5 May 2020
The European Medicines Agency (EMA) has announced that it has started a rolling review of data on the use of the drug of the moment – Gilead Sciences’ remdesivir – for the treatment of coronavirus disease (COVID-19). 1 May 2020
The April deliberations of the European Medicines Agency’s Committee for Medicinal Product for Human Use resulted in a batch of label extensions for already marketed drugs, as well as several novel drugs (see separate story). 1 May 2020
Recommendations for marketing authorizations for four novel drugs and four biosimilars or hybrid medicines following the April 28-30 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 1 May 2020
Shares of Pharming Group were up almost 4% at 1.32 euros in late afternoon trading today, as the Dutch biotech announced that the European Commission has approved an extension in the indication of Ruconest (conestat alfa). 30 April 2020
Interleukin (IL)-17A blocker Cosentyx (secukinumab) has picked up a new approval in Europe, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA). 29 April 2020
The European Commission (EC) has approved Fetcroja (cefiderocol), an antibiotic from Japanese drugmaker Shionogi, to treat infections caused by aerobic Gram-negative bacteria in adults with limited treatment options. 28 April 2020
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and the European Medicines Agency has validated the application for a two-hour Ocrevus (ocrelizumab) infusion time, dosed twice-yearly for relapsing or primary progressive multiple sclerosis (MS). 20 April 2020
The US National Institutes of Health (NIH) is launching a major public-private partnership to speed up COVID-19 vaccine and treatment options. 20 April 2020
US RNAi therapeutics company Alnylam Pharmaceuticals has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). 7 April 2020
Following a positive opinion from the European Medicines Agency’s advisory body the CHMP in late February, Japanese pharma giant Takeda today announced that the European Commission has extended the current marketing authorization of Alunbrig (brigatinib). 6 April 2020
The European Commission has approved both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) for use in adults with primary hypercholesterolemia or mixed dyslipidemia in Europe. 6 April 2020
The European Commission has granted marketing authorization for Rybelsus (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise. 6 April 2020
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