All European Commission (EC) articles
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NewsEU concludes major free trade agreement with Mercosur countries
European pharma industry acknowledges the progress made, particularly with partial tariff reductions, but said further provisions could have been achieved.
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NewsChemical assessment in Europe to be streamlined under new legislation
The European Commission’s new framework aims to improve safety assessment of chemicals to better protect human health and the environment.
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NewsEurope makes progress in its bid to tackle medicine shortages
And as the Critical Medicines Act advances, so too does the Biotech Act, with the moves attracting mixed support from the region’s pharma industry.
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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European Commission calls for bio-based innovation in new EU Bioeconomy Strategy
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
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NewsDupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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NewsInsmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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NewsEurope unveils science strategy as it looks to become an ‘AI continent’
Establishes Resource for AI Science in Europe and eyes frontier AI models and autonomous agentic AI for pharma.
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NewsLilly wins European Alzheimer’s approval for Kisunla after regulatory setbacks
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
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NewsBiogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
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Critical Medicines Act 'must prioritise' EU pharmaceutical manufacturing competitiveness
European Parliament's SANT Committee urges for greater control on medicine provisions to help strengthen security of supply.
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EU Biotech Act public consultation opens for input
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
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NewsEU and US agree preliminary tariffs deal
Marking the first step in the negotiation process, this deal establishes key parameters of the final political agreement on trade and tariffs between the EU and US.
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NewsNovel pre-filled autoinjector receives EU approval
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
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NewsTackling EU supply chain challenges while boosting innovation
Medicines for Europe calls for continued progress of pharmaceutical reforms such as the Critical Medicines Act, to support production of essential medicines in the region.
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NewsEuropean Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
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NewsFirst-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
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NewsCHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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ArticleAdvancing NOX inhibitors for treating fibrotic diseases and cancer
This article explores the benefit of NOX inhibitors for fibrotic diseases and cancers and highlights the potential of Calliditas Therapeutics’ drug setanaxib, including its application in wider related indications.