Japanese mid-sized drugmaker Kyowa Kirin today said its marketing authorization application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson’s disease (PD) experiencing “OFF” time, has been validated by the European Medicines Agency (EMA) and is now under review. 6 January 2020
US ophthalmic drugs specialist Aerie Pharmaceuticals yesterday announced that the European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. 3 January 2020
The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new European Medicines Agency (EMA) building in Amsterdam Zuidas in January 2020. 30 December 2019
US cell and gene therapy company Abeona Therapeutics saw its shares gain 4.2% to $3.75 in after-hours trading Tuesday, after it announced that the European Medicines Agency has granted the designation of Priority Medicines ( PRIME) for its ABO-102, which studies its punctual gene therapy based on adeno-associated virus 9 (AAV9) for the treatment of Sanfilippo syndrome type A (MPS IIIA). 27 December 2019
The Johnson & Johnson unit Janssen has announced that the European Commission (EC) has approved an indication for Spravato (esketamine), the first antidepressant medicine with a new mechanism of action in more than 30 years. 20 December 2019
The European Commission (EC) has approved Kadcyla (trastuzumab emtansine) for the adjuvant treatment of adults with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy. 19 December 2019
European Commission has granted approval for Rinvoq (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). 19 December 2019
A report from the European Medicines Agency (EMA) on pharmacovigilance activities finds that the EU system is: “strong and adaptable,” creating: “a positive impact on public health.” 17 December 2019
There are currently no approved treatments for the increasingly prevalent liver disease non-alcoholic steatohepatitis (NASH), but this looks highly likely to change within the next year. 16 December 2019
Specialist HIV company ViiV Healthcare today announced it has made regulatory submissions to both the European Medicines Agency and the US Food and Drug Administration seeking approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir. 13 December 2019
California’s Amgen and Belgian biotech UCB have won approval in Europe for Evenity (romosozumab), as an option for severe osteoporosis in postmenopausal women at high risk of fracture. 12 December 2019
Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in 2030. 11 December 2019
US drugmaker Vertex Pharmaceuticals has announced that the European Commission has granted a label extension for Kalydeco (ivacaftor) to allow treatment of certain cystic fibrosis (CF) patients aged from six to 12 months. 11 December 2019
The European Medicines Agency has begun its review of a marketing application for Vascepa (icosapent ethyl), from USA-based cardiovascular specialist Amarin. 3 December 2019
The European pharmaceutical industry has signalled its objections over new proposals for European regulations on health technology assessment, arguing that Europe cannot afford an “inefficient system for joint clinical assessments.” 2 December 2019
South Korea’s Celltrion Healthcare today announced that the European Commission has approved Remsima SC (CT-P13 SC, biosimilar infliximab) for patients with rheumatoid arthritis (RA). 26 November 2019
Californian biotech BioMarin Pharmaceutical has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. 22 November 2019
The overlap between developing medicines for pediatric conditions and for rare diseases is something that impacts many drug companies, bringing opportunities and potential complexities. 21 November 2019
Merck & Co has racked up another European approval for its anti-PD-1 workhorse Keytruda (pembrolizumab), as a first-line treatment for certain people with head and neck cancer. 20 November 2019
Janssen has received European Commission (EC) marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT). 20 November 2019
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