The European medicines regulator is to review a bid from Germany’s Merck KGaA and New York’s Pfizer to extend the marketable use of Bavencio (avelumab). 22 June 2020
The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA). 18 June 2020
The major European pharma trade groups have written to the European Commission president Ursula von der Leyen and other officials, to prioritize health and patients’ access to medicines in the EU-UK Brexit negotiations, and shield them from larger political considerations. 18 June 2020
Faced with COVID-19, Brexit and the transition to a new executive director, the European Medicines Agency (EMA) has been presented with the perfect storm of challenges that have landed on its plate thick and fast. 15 June 2020
The European Medicines Agency has validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) under development by privately-held Danish dermatology specialist LEO Pharma. 12 June 2020
The European Commission has granted approval for a label extension on Kalydeco (ivacaftor), the only drug approved in Europe to treat the underlying cause of cystic fibrosis. 10 June 2020
The European Union’s Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on June 3, 2020, the European Medicines Agency reported on Monday. 9 June 2020
The European Medicines Agency (EMA) has received Gilead Sciences’ application for conditional marketing authorization (CMA) of remdesivir for the treatment of COVID-19. 8 June 2020
The European medicines regulator has granted approval for the first adjuvanted quadrivalent influenza vaccine (aQIV), developed by Seqirus, the vaccine unit of Australian biotech firm CSL. 8 June 2020
Mylan and India’s Lupin say the European Commission (EC) has granted marketing authorization for Nepexto, a biosimilar to Amgen’s (Nasdaq: AMGN) Enbrel (etanercept). 5 June 2020
Slightly more than a month after the US Food and Drug Administration approved the product, the European Commission (EC) has also granted marketing authorization for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM), says US healthcare giant Johnson & Johnson. 5 June 2020
The European Commission (EC) has approved Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy, says privately-held French drugmaker Pierre Fabre. 4 June 2020
The European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. 2 June 2020
Applications for a new indication have been submitted to the US Food and Drug Administration and European Medicines Agency for Rinvoq (upadacitinib) 15mg, once daily, a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis, by US biopharma major AbbVie. 2 June 2020
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six novel medicines for approval at its May 2020 meeting. The recommendations will now to the European Commission, which usually provides its final decision within two or three months. 30 May 2020
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. 27 May 2020
New research commissioned by the European Medicines Agency (EMA) will seek to ensure that the region is ready for effective monitoring of potential COVID-19 vaccines, once they are approved and in use. 27 May 2020
A week after the US Food and Drug Administration (FDA) refused to review idecabtagene vicleucel (ide-cel; bb2121), the European Medicines Agency (EMA) has accepted a filing for the CAR-T therapy. 23 May 2020
Medical regulatory bodies from around the world have agreed three priority areas for cooperation on observational research during COVID-19. 21 May 2020
US biotech Incyte closed up 3.6% at $98.32 yesterday, after announcing, along with partner German drugmaker MorphoSys, the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody, had been validated. 21 May 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