EMA Regulatory News
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Biotechnology
The recent European Commission approval for Sotyktu (deucravacitinib), US pharma major Bristol Myers Squibb’s first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for adults with moderate-to-severe plaque psoriasis (PsO), has elicited comment from a leading data and analytics firm. 11 May 2023
Pharmaceutical
French drugmaker Servier has secured European approval for Tibsovo (ivosidenib) in two indications, making it the first and only IDH1 blocker to be available in the region. 11 May 2023
Biotechnology
Alexion, a subsidiary of Anglo-Swedish pharma major AstraZeneca with a focus on rare diseases, has scored another win in neuromyelitis optica spectrum disorder (NMOSD). 10 May 2023
Biotechnology
A new Fabry disease therapy, PRX-102 (pegunigalsidase alfa), has been given marketing authorization by the European Medicines Agency. 9 May 2023
Pharmaceutical
The European Medicines Agency is considering changing the transparency rules around clinical trials, with a public consultation on the matter now open. 4 May 2023
Biotechnology
The European Commission (EC) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for a number of new lymphoma indications. 3 May 2023
Pharmaceutical
The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting. 28 April 2023
Pharmaceutical
The European Commissiont has issued a long-anticipated set of proposals to reform the legislative framework for medicines in the region. 26 April 2023
Pharmaceutical
Kidney disease specialist Akebia Therapeutics saw its shares lifted over 6% on Monday, following a European approval for Vafseo (vadadustat). 26 April 2023
Pharmaceutical
The European Medicines Agency has provided Johnson & Johnson with its first regulatory approval for Akeega (niraparib/abiraterone acetate). 24 April 2023
Biotechnology
French gene therapy company GenSight Biologics saw its shares crash 69% by close of trading on Friday, and fall a further 10.3% to 0.66 euros in early trading today, after it announced the withdrawal of its European regulatory filing for what could be the first gene therapy for Leber hereditary optic neuropathy (LHON) patients. 24 April 2023
Pharmaceutical
The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials submitted as pivotal evidence in support of marketing authorization applications. 21 April 2023
Biotechnology
The European Commission has granted a marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 21 April 2023
Biotechnology
The European Commission (EC) has approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 18 April 2023
Pharmaceutical
Research from industry analyst GlobalData highlights the significance of the pediatric treatment opportunity for Novartis’ Entresto (sacubitril/valsartan). 18 April 2023
Biotechnology
Moderna and Merck & Co have announced that mRNA-4157/V940 alongside Keytruda (pembrolizumab) has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of high-risk stage III/IV melanoma following complete resection. 11 April 2023
Biosimilars
At its March 2023 meeting, the European Medicines Agency’s human medicines committee (CHMP) came up with positive recommendations for six novel medicines. 31 March 2023
Pharmaceutical
Draft EU regulatory proposals have been described by the leading European trade body as “sabotage” of the industry. We consider the fallout with Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin. 31 March 2023
Biotechnology
Two years after the US regulator concluded it was necessary to increase label warnings on safety for certain JAK inhibitors, the European Medicines Agency has followed suit. 31 March 2023
Biotechnology
The European Commission (EC) has approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression, US biotech firm Regeneron revealed today. 29 March 2023
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Biosimilars
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
Pharmaceutical
Japanese drugmaker Astellas Pharma revealed it has decided to withdraw its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP). 28 October 2024
Biotechnology
AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). 28 October 2024
Biotechnology
Johnson & Johnson has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation. 24 October 2024
Biotechnology
The European Commission (EC) has approved two new indications for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in gynecologic cancers. 24 October 2024
Biosimilars
The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Imuldosa. 21 October 2024
Biotechnology
The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting. 18 October 2024
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