Eisai EMEA in the news
patient-focused innovative medicine development
Tamtam found 20 recent articles about Eisai EMEA.
- Eisai wins EMA acceptance for lemborexant insomnia filing in Europe
Eisai secured EMA acceptance for its lemborexant marketing application to treat adult chronic insomnia in Europe.
- LEQEMBI® Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer’s Disease Presented at the Alzheimer’s Association International Conference® (AAIC®) 2026
New clinical data confirms the LEQEMBI subcutaneous autoinjector's efficacy and safety are comparable to its intravenous counterpart for early Alzheimer's, offering greater convenience for patients and caregivers.
- Slovenia's Salus signs lecanemab distribution deal with Eisai EMEA
Salus of Slovenia signed a distribution agreement with Eisai EMEA for the drug lecanemab.
- Eisai claims UK grant to expand manufacturing site
Eisai secured a UK government grant to expand its Hatfield manufacturing site for cold-chain medicines, investing £48 million to enhance supply capabilities and create jobs.
- Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Designated for Priority Review in China
Eisai and Biogen's subcutaneous LEQEMBI for early Alzheimer's disease received Priority Review in China, promising home-based, once-weekly treatment.
- Eisai and Nuvation Bio Enter into Exclusive Licensing Agreement for Taletrectinib in Europe and Additional Countries Outside the U.S., China and Japan
Eisai secured exclusive rights to develop and commercialize Nuvation Bio's lung cancer drug taletrectinib in Europe and several other international markets for up to EUR 195 million in total payments.
- Nuvation Bio and Eisai Enter into Exclusive Licensing Agreement for Taletrectinib in Europe and Additional Countries Outside U.S., China and Japan
Eisai has secured exclusive rights to develop and commercialize the lung cancer drug taletrectinib across Europe and other major international markets through a deal with Nuvation Bio.
- Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2025
Eisai announced new data on LEQEMBI showing it can significantly delay Alzheimer's disease progression, along with promising results for a subcutaneous formulation under regulatory review.
- Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan
Eisai submitted a new drug application in Japan for a subcutaneous, at-home injection formulation of LEQEMBI to treat early Alzheimer's disease.
- Eisai shares long-term data on lecanemab at neurology congress
Eisai presented long-term data at a neurology congress showing lecanemab's sustained benefits and reduced disease progression risk in early Alzheimer's patients.
- Eisai, Biogen's Alzheimer's med Leqembi wins long-awaited European approval
Leqembi has received European approval for treating early-stage Alzheimer's in patients with low risk for specific genetic side effects.
- Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer’s Disease in Australia
Eisai faces a regulatory setback in Australia as the TGA declined to approve its Alzheimer’s treatment lecanemab following a disagreement over patient indication restrictions.
- The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer’s Disease
Eisai and Biogen move closer to European approval for their Alzheimer’s drug lecanemab following a reaffirmed positive recommendation from the EMA regulatory committee.
- 5 minutes with… Jaime Manzanera, Eisai
Jaime Manzanera emphasizes that pharmaceutical success depends on integrating CRM tracking with face-to-face medical interactions while carefully scaling AI technologies.
- Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
Eisai and Biogen are addressing European Commission requests for further safety clarifications to secure final EU approval for their Alzheimer’s treatment lecanemab.
- Eisai, Biogen's Alzheimer's med Leqembi turned down in Europe—but analyst says it's merely a 'delay'
European regulators rejected Eisai and Biogen's Alzheimer's drug Leqembi due to safety concerns regarding brain swelling and bleeding.
- FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
The FDA is reviewing a new monthly IV maintenance dosing schedule for the Alzheimer’s drug LEQEMBI to reduce patient treatment burden.
- Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease to the U.S. FDA
Eisai has submitted a supplemental application to the FDA for a monthly intravenous maintenance version of its Alzheimer’s drug, LEQEMBI.
- Eisai: Laying the Foundation for Centralized Medical Information Management
Eisai centralized its medical information management using Veeva Vault MedComms to enhance consistency, compliance, and efficiency across its global operations, starting with a phased rollout in EMEA.
- Japanese Pharmaceutical Company Eisai Expands UK Site with New Facility
Eisai is expanding its Hatfield headquarters with an £8 million high-potency packaging facility to support global supply of cancer and epilepsy medicines.
Articles collected by Tamtam and kept when they are about the company, newest first. Each links to its source.
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