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The European Medicines Agency today released highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting that was held November 27-30, 2017. 1 December 2017
Pharmaceutical
Last week’s major news included the long-awaited decision on the new location for the European Medicines Agency, and more lay-offs at Israeli generics giant Teva Pharmaceutical Industries. On the research front, Roche hit the headlines with important new data on its cancer drug Tecentriq and hemophilia treatment Hemlibra, and the failure of Cytokinetics’ ALS drug candidate tirasemtiv. There was also positive regulatory news for Janssen, with the company gaining European approval for its prostate cancer drug Zytiga as a first-line therapy, and GlaxoSmithKline being granted Food and Drug Administration clearance for Juluca, the fist single-pill doublet to treat HIV. 26 November 2017
Pharmaceutical
European Medicines Agency executive director Professors Guido Rasi’s tenure in the post has had its dramatic moments, since the annulment of his 2011 appointment in 2014 after allegations that the recruitment procedure had been wrong by Emil Hristov, a former top Bulgarian drug regulator, who applied for the job but was left off the shortlist. 25 November 2017
Biotechnology
Janssen-Cilag International, part of the US healthcare giant Johnson & Johnson, has announced that the European Commission (EC) has approved Tremfya (guselkumab) to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. 23 November 2017
Pharmaceutical
The European Medicines Agency has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). 23 November 2017
Pharmaceutical
The long awaited European Medicines Agency relocation decision provides some certainty to the life sciences industry in an otherwise uncertain Brexit process, according to Helen Kimberley, a lawyer in Hogan Lovells' Commercial and Regulatory team, said. 21 November 2017
Pharmaceutical
The European Commission has given its backing to broaden the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer than its current indications. 21 November 2017
Pharmaceutical
European heads of state have chosen Amsterdam as the new home for the European Medicines Agency post-Brexit, simultaneously ending months of speculation and the hopes of 18 other nations bidding to host the prestigious organization. 21 November 2017
Biosimilars
Samsung Bioepis has had its marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), approved by the European Commission (EC). 20 November 2017
Pharmaceutical
Last week’s most interesting news included a mega licensing deal by Germany’s Bayer, which acquired rights to Loxo Oncology’s cancer candidate larotrectinib for up to $1.55 billion. There was also a great deal of news on the regulatory front, with Heron Therapeutics gaining US Food and Drug Administration approval for its CINV drug Cinvanti. Celgene and bluebird bio were granted Breakthrough and PRIME designation for their multiple myeloma candidate bb2121, and FDA approval came through for AstraZeneca’s asthma drug Fasenra and Ultragenyx’ Sly syndrome treatment Mepsevii. 19 November 2017
Biotechnology
A CAR-T therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and PRIME eligibility by the European Medicines Agency (EMA). 17 November 2017
Pharmaceutical
AstraZeneca announced three separate approvals of products in asthma and cancer on Tuesday and closed 1.8% up in the stock market. 15 November 2017
Biosimilars
The European Commission followed in the footsteps of the US Food and Drug Administration (FDA) by approving the Humira (adalimumab) biosimilar being developed by privately-owned drugmaker Boehringer Ingelheim. 13 November 2017
Biotechnology
The European Medicines Agency has concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage, the EMA announced on Friday. 11 November 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new drugs for approval, including two orphan medicines and one biosimilar, at its November 2017 meeting. 10 November 2017
Pharmaceutical
An application has been lodged with the European Medicines Agency to extend the label for Xarelto, in combination with aspirin, to treat coronary artery disease (CAD) or peripheral artery disease (PAD). 7 November 2017
Biotechnology
Novartis today announced it has submitted a Marketing Authorization Application to the European Medicines Agency for Kymriah (CTL019; tisagenlecleucel) for two hematological indications. 6 November 2017
Biotechnology
US pharma giant Merck & Co is having a ghastly Halloween season. 30 October 2017
Biotechnology
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver. 28 October 2017
Pharmaceutical
On November 20, the question of which country will host the European Medicines Agency post-Brexit will finally be settled, at the European Council’s General Affairs (Art. 50) meeting. 25 October 2017
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
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