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Norgine B.V. submits Marketing Authorisation Application via Project Orbis for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma
Amsterdam (ots/PRNewswire) - Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to ...
mehrEuropean Parliament Recognizes Essential Tremor as Official Disease in Ground-Breaking Declaration
Brussels (ots/PRNewswire) - The Insightec-organized conference resulted in a Joint Declaration, promising new hope for patients suffering from the condition The European Parliament, in collaboration with Insightec and patient advocacy groups, has taken a historic step forward in the healthcare realm by signing a ...
mehrIsotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, has received marketing authorization in the Netherlands (RVG 130527)
Petach Tikva, Israel (ots/PRNewswire) - Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing authorization in the Netherlands (RVG 130527). This landmark approval marks a significant milestone in our ongoing commitment to improve healthcare and patient ...
mehrNESPRESSO WILL INVEST 20 MILLION USD IN DRC TO SUPPORT THE COFFEE GROWING COMMUNITY AND THE REVIVAL OF THE SPECIALTY COFFEE
Vevey, Switzerland (ots/PRNewswire) - Focusing on an increased sourcing of high-quality coffee, as well as implementing regenerative practices, gender equality programs and projects to increase access to healthcare and clean water. Nespresso aims to continue to support the local community and economy by investing 20 ...
mehrNorgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
Amsterdam (ots/PRNewswire) - Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia. The ...
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11FDI World Dental Federation releases powerful video message unifying voices in celebration of World Oral Health Day
mehrFennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand
Research Triangle Park, N.C. and Uxbridge, England (ots/PRNewswire) - Agreement pairs Norgine's commercial expertise and leading European footprint with PEDMARQSI™, the first and only approved therapy in the European Union and U.K. for reducing the risk of cisplatin-induced hearing loss in pediatric patients with ...
mehrPulsenmore is expanding the application of its home ultrasound solution for pregnant women: a clinical trial with Michigan Medicine will focus on the remote assessment of the fetal biophysical profile
Ramat Gan, Israel (ots/PRNewswire) - Pulsenmore (TASE:PULS), the world leader in self-scan ultrasound technology for at-home use and remote clinical diagnosis, announces its new clinical study collaboration with Michigan Medicine. The study will examine the ability to conduct a remote biophysical profile (BPP) test, ...
mehrEpitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance
Caesarea, Israel (ots/PRNewswire) - Epitomee® (TASE: EPIT) announced today that on February 27, 2024, it has submitted its Weight Loss Capsule for FDA clearance in the USA, reaching a significant milestone in the company's journey. The Epitomee® capsule offers an innovative, orally administered, drug free, and clinically proven as effective and safe solution, for ...
mehrPhagenesis, a medical device company specializing in the treatment of swallowing disorders, successfully closes a $42M Series D financing round led by EQT Life Sciences and Sectoral Asset Management
Manchester, England (ots/PRNewswire) - Phagenesis, a pioneering UK company which has developed a revolutionary neurostimulation system to treat swallowing dysfunction, has closed a $42M Series D financing all equity investment round. The combined European and United States investment syndicate was led by EQT Life ...
mehrProcare Health: Silencing HPV infection may exacerbate the physiological effects of the emotional burden
Valencia, Spain (ots/PRNewswire) - The emotional impact of a human papillomavirus (HPV) diagnosis is significant, often leading to feelings of fear, worry, guilt, and self-stigmatization among women. Recognizing the importance of addressing these emotions alongside physical symptoms, Procare Health organized the ...
mehrInsightec's Groundbreaking Transcranial MR-Guided Focused Ultrasound (MRgFUS) Approved for Additional Reimbursement for Essential Tremor in Germany
Berlin (ots/PRNewswire) - Germany is latest – and largest – European country to enable substantial access to focused ultrasound, offering new hope of relief for those suffering with movement disorders Insightec, a pioneer and global leader in focused ultrasound, is pleased to announce that its transcranial ...
mehrJohnson & Johnson Biosense Webster
Biosense Webster Announces CE Mark approval in Europe for VARIPULSE™ Pulsed Field Ablation (PFA) Platform
Irvine, Calif. (ots/PRNewswire) - - Regulatory approval for the first fully integrated PFA system with a CARTO-enabled simple and reproducible workflow. - Integrated with the world's leading CARTO™ 3D Cardiac Mapping System for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation ...
mehrPolaroid Therapeutics completes pre-clinical milestones in the development of superior antimicrobial technology for acute and chronic wounds
Bern, Switzerland (ots/PRNewswire) - - Its proprietary innovative polymer technology reduces bacterial bioburden without triggering antimicrobial resistance, one of the top global public health threats - The Advanced Wound Dressing (AWD) market is valued at 4.5 billion USD and is witnessing increasing demand and ...
mehrINSIGHTEC MR-GUIDED FOCUSED ULTRASOUND TECHNOLOGY RECOMMENDED FOR NATIONAL COVERAGE FOR DUTCH PATIENTS LIVING WITH ESSENTIAL TREMOR
Amsterdam (ots/PRNewswire) - The Netherlands is the latest European country to recommend national coverage for the treatment of essential tremor with focused ultrasound. Insightec, a pioneer and global leader in focused ultrasound, has welcomed a positive recommendation report[1] from the Dutch Healthcare Institute ...
mehrEpitomee® Announces Successful Completion of Pivotal Clinical Trial for Innovative Weight Loss Capsule
Caesarea, Israel (ots/PRNewswire) - Epitomee® announces the successful completion of the RESET pivotal clinical trial, for its weight loss capsule. The randomized placebo controlled, double blind trial, investigated the safety and efficacy of Epitomee® capsule versus the sham capsule control, alongside lifestyle ...
mehrThe International Diabetes Federation (IDF)
International Diabetes Federation and Sanofi Global Health Unit collaborate to strengthen diabetes response in 40 countries
Brussels (ots/PRNewswire) - The partnership will enhance diabetes care through training aimed at building capacity among healthcare professionals in low and middle-income countries. The International Diabetes Federation (IDF), in collaboration with Sanofi's Global Health Unit (GHU), is taking significant steps to ...
mehrMedison Pharma Announces Agreement with Regeneron Pharmaceuticals to Commercialize Libtayo® (cemiplimab) in Multiple Countries
Zug, Switzerland (ots/PRNewswire) - - Libtayo (cemiplimab) is a leading PD-1 inhibitor that has shown efficacy in the treatment of certain patients with cutaneous squamous cell carcinoma, advanced basal cell carcinoma, advanced non-small cell lung cancer and advanced cervical cancer, and is approved by regulatory ...
mehrPRODUCTLIFE GROUP ACQUIRES LIFEBEE, STRENGTHENING ITS CAPACITY TO SUPPORT DIGITAL TRANSFORMATION IN LIFE SCIENCES
Paris (ots/PRNewswire) - ProductLife Group (PLG), the global consulting provider of regulatory, scientific, vigilance and quality services for the life sciences industries, announces the acquisition of LifeBee, a leading Italian and Swiss based consulting firm providing digital transformation, operational excellence ...
mehrTakeda Pharma Vertrieb GmbH & Co. KG
The European Commission Approves Label Update for TAKHZYRO® (lanadelumab), Expanding Its Use to a Broader Group of Paediatric Patients with Recurrent Attacks of Hereditary Angioedema (HAE)
Zurich (ots/PRNewswire) - - TAKHZYRO® is the First Routine Prevention Treatment of HAE Approved in the EU for Patients Under the Age of Six. - The therapeutical indication for TAKHZYRO® has been extended to patients aged 2 years and older.1 - Offers a New Preventative Treatment Option for young HAE patients with ...
mehrNew Published Study Demonstrates Safety and Feasibility of Filterlex Medical's CAPTIS® Device in Providing Embolic Protection During TAVR
Caesarea, Israel (ots/PRNewswire) - Peer-Reviewed EuroIntervention Journal Publishes First-in-Human Study Finding Filterlex Medical's CAPTIS® Embolic Protection Device Performed Well and is Safe During Transcatheter Aortic Valve Replacement (TAVR). Filterlex Medical Ltd., a cardiovascular medical device startup, ...
mehrIpsen and Medison Pharma Announce Health Canada Approval of Bylvay™ (odevixibat) for the treatment of pruritus due to Progressive Familial Intrahepatic Cholestasis (PFIC)
Zug, Switzerland and Paris (ots/PRNewswire) - Bylvay (odevixibat) is the first and only oral treatment available in Canada for the treatment of pruritus due to this rare genetic condition Today, Ipsen (Euronext: IPN) (ADR: IPSEY), a global biopharmaceutical company focused on transformative medicines in oncology, ...
mehrAntech launches first comprehensive veterinary diagnostics offering in the UK, including a new state-of-the-art reference laboratory
Warwick, England, 7 Nov. 2023 (ots/PRNewswire) - Antech to offer UK veterinary professionals a complete and flexible diagnostics portfolio spanning reference labs, in-house diagnostics, imaging and software Antech, the full-service veterinary diagnostics business that is part of the Science & Diagnostics division of ...
mehrSoterios Pharma completes Phase II enrolment for STS-01 in mild / moderate (patchy) alopecia areata
London (ots/PRNewswire) - Soterios Pharma, a privately held clinical-stage pharmaceutical company, announced today that it has completed target enrolment for its Phase II trial with STS-01 for mild / moderate (patchy) alopecia areata. Final results of the study are anticipated to be available in Q2 2024. David Fleet, CEO of Soterios Pharma, said, "This represents an ...
mehrAPRIL International strengthens its presence in Europe with the acquisition of Expat & Co in Belgium
Lyon, France and Paris (ots/PRNewswire) - APRIL Group, Europe's leading wholesale insurance broker, announces the acquisition of Expat & Co, a specialist in international health insurance in Belgium. Expat & Co is the leading independent underwriter of insurance for expatriates in Belgium and offers a platform of ...
mehrHearing Loss Company Acousia Therapeutics Green Lighted for Game-Changing Phase 2 Trial
Tübingen, Germany (ots/PRNewswire) - Acousia Therapeutics, a pioneer clinical-stage biotech company focused on the development of novel drug therapies for the prevention and treatment of acute and chronic forms of hearing loss, received approval from the German regulatory authorities (BfArM) for its groundbreaking Phase 2 clinical trial of the etiology-agnostic ...
mehrEuropean Academy of Allergy and Clinical Immunology
EAACI International Severe Asthma Forum (ISAF) Hybrid 2023: Advancing Severe Asthma Care
Zurich (ots/PRNewswire) - The Organising Committee of the EAACI International Severe Asthma Forum (ISAF) is pleased to announce the upcoming ISAF Hybrid 2023 event, scheduled to take place in the historic city of Rome from October 05 to October 07, 2023. This event will unite global experts and emerging professionals to address the challenges of severe asthma and ...
mehrTakeda Receives Positive CHMP Opinion Recommending Approval of Lanadelumab for Routine Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) in Patients Aged 2 years and Older
Zurich (ots/PRNewswire) - - If Approved, Lanadelumab Will be the First Long-Term Prophylactic Treatment of HAE Available in the EU for Patients Under the Age of Six. - Positive Opinion Based on Pivotal Study SHP643-301, Evaluating the Safety Profile and Pharmacokinetics (PK) of Lanadelumab, in Combination with ...
mehrSilony Medical International AG
Silony Medical acquires Centinel Spine's Global Fusion Business
Frauenfeld, Switzerland (ots/PRNewswire) - The transaction includes all cervical and lumbar fusion products, including the STALIF® technology platform Silony Medical International AG (the company), a growing challenger to "big medtech" in the global spinal fusion market, has signed a definitive agreement to acquire Centinel Spine's Global Fusion Business. This combines Silony's Verticale® posterior screw & rod fusion ...
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