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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
Pharmaceutical
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorization Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). 5 March 2018
Pharmaceutical
UK Prime Minister Theresa May’s “Road to Brexit” speech today in London held some supportive statements for the pharmaceutical industry and its future collaboration with European Union regulatory agencies when Britain leaves the EU in March next year. 2 March 2018
Biotechnology
US biotech Biogen and its partner AbbVie have announced the voluntary worldwide withdrawal of the multiple sclerosis (MS) drug Zinbryta (daclizumab). 2 March 2018
Pharmaceutical
The European Medicines Agency (EMA) has taken a step closer to formalizing its move to Amsterdam after accepting the pledge of the Dutch government that its brand new, tailor-made premises will be ready in the city by November 2019. 1 March 2018
Biotechnology
The European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors. 28 February 2018
Pharmaceutical
UK-headquartered Seqirus today announced its intention to commercialize its cell-based quadrivalent flu vaccine (QIVc) in Europe. 28 February 2018
Pharmaceutical
The New Drug Application (NDA) for lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, has been accepted for filing and has been granted Priority Review by the US Food and Drug Administration. 27 February 2018
Pharmaceutical
Research published in the European Journal of Clinical Pharmacology has shown that the US Food and Drug Administration consistently beats other agencies to the finishing line in approving new drugs. 26 February 2018
Pharmaceutical
Regulatory matters figured prominently in the news last week, with the European approval of Kyowa Hakko Kirin and Ultragenyx Pharmaceuticals’ rare disease drug Crysvita and US clearance of a much awaited new indication for AstraZeneca’s immuno-oncology drug Imfinzi in lung cancer. Licensing news also attracted attention, with AbbVie’s Alzheimer’s disease collaboration with Voyager Therapeutics, Takeda’s accord with Wave Life Sciences, and Gilead Sciences’ new subsidiary Kite Pharma’s deal with Sangamo in the CAR-T space race. Merck & Co’s acquisition of Australian firm Viralytics, thus dipping its toe into the field of oncolytic virus, was a feature for M&A, and there were mixed reactions to Aimmune’s successful clinical trial in peanut allergy. 25 February 2018
Biotechnology
Japan’s Kyowa Hakko Kirin and US biotech Ultragenyx Pharmaceutical today announced that Crysvita (burosumab) has received a positive European Commission decision granting a conditional marketing authorization. 23 February 2018
Pharmaceutical
Following its monthly meeting in February, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines. 23 February 2018
Pharmaceutical
It has been nearly two years since the UK voted to leave the European Union. While we find ourselves only a year away from the official exit, significant ambiguity remains, and important negotiations still must take place, notes Paul Brooks, executive director of the Regulatory Affairs Professionals Society (RAPS). 16 February 2018
Pharmaceutical
In a fast-moving COPD field where triple combination therapies are driving much of the momentum, GlaxoSmithKline has sought to widen its patient population in Europe. 14 February 2018
Biosimilars
The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. 14 February 2018
Pharmaceutical
The safety board of the European Medicines Agency says that doctors should stop initiating treatment with Esmya (ulipristal acetate), pending a safety investigation. 13 February 2018
Biotechnology
In the week that it announced impressive data for apalutamide, Janssen has submitted a Marketing Authorization Application (MAA) for the new prostate cancer candidate to the European Medicines Agency (EMA). 9 February 2018
Pharmaceutical
The European Union’s General Court today delivered three landmark rulings for the European Medicines Agency, upholding the EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation.” 6 February 2018
Pharmaceutical
Today the European Commission has put forward a proposal to boost cooperation amongst European Union member states for assessing health technology. 31 January 2018
Pharmaceutical
French pharma major Sanofi has asked the European Medicines Agency to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). 31 January 2018
Pharmaceutical
As a result of the UK leaving the European Union effective March 29, 2019, the relocation of the European Medicines Agency from London to Amsterdam in the Netherlands is likely to cause some logistic problems, the EMA executive director Guido Rasi explained at a meeting in The Hague with Dutch health authorities. 29 January 2018
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