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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
Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Biotechnology
Significant research news last week saw US biotech Scholar Rock release positive new data for its spinal atrophy (SMA) candidate apitegromab. There was a negative development for Johnson & Johnson, which said that, following a data monitoring committee recommendation, it is discontinuing development or its TAR-200 in bladder cancer. On the regulatory front, the US Food and Drug Administration (FDA) approved Swiss pharma giant Roche’s new breast cancer drug Itovebi (inavolisib). Also of note, the European Medicines Agency’s pharmacovigilance committee, PRAC, has initiated a review of medicines containing finasteride and dutasteride regarding suicidal ideation and behaviors. 13 October 2024
Biosimilars
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Biosimilars
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
Pharmaceutical
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
Pharmaceutical
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Biotechnology
Biogen and Eisai have announced that the European Medicines Agency (EMA) has confirmed it has accepted for review the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. 30 October 2020
Pharmaceutical
For two years from January 1, 2021, once the transition period after Brexit has come to an end, the UK will adopt decisions taken by the European Commission (EC) on the approval of new medicines in the community marketing authorization procedure. 27 October 2020
Biotechnology
US cancer metabolism specialist Agios Pharmaceuticals late Friday announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. 19 October 2020
Pharmaceutical
At its October meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for approval. These now go the European Commission, which usually provides a final decision within two to three months. 16 October 2020
Biotechnology
The European Medicines Agency has confirmed that mRNA-1273, a vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure, said the vaccine’s developer. 14 October 2020
Pharmaceutical
The European Medicines Agency’s (EMA) initiative to implement exceptional transparency measures that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19 has been praised by two trade groups representing the pharmaceutical industry. 14 October 2020
Biotechnology
Last week’s notable news included Bristol Myers Squibb making a further push into the cardiovascular arena with a $13.1 billion bid for MyoKardia and its drug mavacamten. Australia’s Mesoblast suffered a setback with the US Food and Drug Administration issuing a complete response letter (CRL) on its graft versus host disease candidate Ryoncil. Coronavirus was never out of sight, with the European Medicines Agency using its emergency program of rolling reviews for two COVID-10 vaccines: AstraZeneca’s AZD1222 and also Pfizer and BioNTech’s BNT-162b2. Also, despite warnings from the Trump administration, the FDA last week issued guidelines on the submission and review of COVID-19 vaccine that contain provisions that would prevent any such products being cleared before the November 3 presidential elections. On the research front, Axovant Gene Therapies released new Phase II data on its Parkinson’s disease candidate AXO-Lenti-PD that investors did not view as positive as the company. 11 October 2020
Pharmaceutical
The European Commission (EC) has approved an advance purchase agreement in which Johnson & Johnson’s Janssen unit will supply 200 million doses of its COVID-19 vaccine candidate to European Union (EU) member states following regulatory approval. 8 October 2020
Biotechnology
Less than a week after the European Medicines Agency (EMA) started the first ‘rolling review’ of a COVID-19 vaccine, the regulator has begun another. 6 October 2020
Biosimilars
South Korea’s Samsung Bioepis and Biogen today announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). 6 October 2020
Pharmaceutical
At the October 2020 meeting of the European Medicines Agency’s management board, the particular focus was on the Agency’s activities in response to the COVID-19 pandemic. 5 October 2020
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of a safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir). 3 October 2020
Biotechnology
The European Commission (EC) has approved Crysvita (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphatemia (XLH), Japanese drugmaker Kyowa Kirin announced today. 2 October 2020
Pharmaceutical
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for avalglucosidase alfa, for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. 2 October 2020
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, AZD1222, which is being developed by AstraZeneca in collaboration with the University of Oxford. 1 October 2020
Biosimilars
Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca, has announced that its biosimilar to Roche’s Avastin (bevacizumab) has been approved by the European Commission (EC). 30 September 2020
Biotechnology
Hot on the heels of Japanese approval earlier the same day, late Friday Gilead Sciences and partner Galapagos revealed that the European Commission (EC) has granted marketing authorization for Jyseleca (filgotinib) 200mg and 100mg tablets. 28 September 2020
Biotechnology
Last week’s regulatory news saw Bristol Myers Squibb reveal that the US Food and Drug Administration has accepted and granted priority review of its CAR-T cell therapy idecabtagene vicleucel (liso-cel), under development with bluebird bio, but the late decision date could have a serious impact on the contingent value rights (CVR) for Celgene’s former shareholders. Also, although the FDA agreed that Novartis’ intrathecal (IT) formulation of AVXS-101 has potential, the agency has called for a pivotal confirmatory study to support the regulatory submission. Additionally, US biotech Blueprint Medicines revealed on Friday that it has gained approval for its Ayvakyt (avapritinib) from the European Commission in the treatment of metastatic gastrointestinal tumorous (GIST) harboring the PDGFRA D842 mutation. On the research front, Roche and partner AC Immune posted top-line results for semorinemab in early Alzheimer’s, which failed key endpoints. 27 September 2020
Biotechnology
US rare and cancer diseases specialist Blueprint Medicines said on Friday that the European Commission has granted conditional marketing authorization to Ayvakyt (avapritinib) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. 26 September 2020
Biotechnology
The US Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for its interleukin (IL)-17 inhibitor bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. 23 September 2020
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