Storys zum Thema Medikament
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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 ...
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 ...
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 ...
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 ...
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 ...
mehrSchweizerischer Nationalfonds / Fonds national suisse
Wie Fadenwürmer altern - und was das für die Menschen bedeuten könnte
Bern (ots) - Ein Protein reduziert die Lebenserwartung von Fadenwürmern. Diese Entdeckung wirft die Frage auf, ob es beim Menschen ebenfalls den Alterungsprozess mitbewirkt. Selbst von den am besten erforschten Genen und Proteinen kennt man noch längst nicht alle Geheimnisse. Wie das Schweizer Taschenmesser haben sie zahlreiche, teilweise unbekannte Funktionen. Mit ...
mehrHearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study
Tübingen, Germany (ots) - Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, just announced the randomization of the first patient for the PROHEAR-Study. The PROHEAR-Study is a placebo-controlled, Phase 2a study with split-body design, which investigates the otoprotective efficacy ...
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 ...
mehrSHL Medical partners with SteriPack Group to set up final assembly service
Zug, Switzerland (ots) - SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack ...
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 ...
mehrAcousia Therapeutics attracts new investor on its path to make hearing loss a treatable disease
Tübingen (ots) - - German pioneer biotech accelerates hearing loss solution development with fresh capital boost Acousia Therapeutics GmbH, a clinical-stage biotech company developing drug candidates against acute and chronic forms of hearing loss, proudly announces Esperante Ventures as the latest addition to its esteemed group of investors. The infusion of fresh ...
mehrBE LIGHT the shortcut to well-being and mental health
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 ...
mehrBehaVR and Fern Health Merge To Form RealizedCare, Launch Digital Care Management Platform to Unlock the Value of Digital Therapeutics
NASHVILLE, Tenn., Aachen, Germany (ots) - The merger will accelerate a new digitally-powered care management solution for chronic pain and beyond; Pharmaceutical company Grünenthal becomes the largest investor in the combined enterprise BehaVR, a pioneering force in digital therapeutics (DTx) experiences, and Fern ...
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 ...
mehrSchweizerischer Nationalfonds / Fonds national suisse
2Do bacteria make you fat? Prizewinner Maria Luisa Balmer is looking for answers
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 ...
mehrHearing Loss Company Acousia Therapeutics Green Lighted for Game-Changing Phase 2 Trial
Tübingen, Germany (ots) - 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 otoprotectant ...
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 ...
mehrLatest Sports & Fitness Innovation: Holistic Training Syllabus by MAVERICKS Life Co.
CRANS-MONTANA, Switzerland (ots/PRNewswire) - Sports science & wellbeing education company, MAVERICKS Life Co., announces the release of its new Holistic Training Syllabus, rooted in evolutionary biology and epigenetics theory. It's a brand new innovation in the sports and fitness sector. Recent scientific studies* have led to groundbreaking development that is ...
mehrIsotopia Issues a call to action to the radionuclide Therapy industry.
Petah Tikva, Israel (ots/PRNewswire) - Isotopia Molecular Imaging is a global pharmaceutical company that develops, produces, and distributes therapeutic and diagnostic radioactive isotopes. "If you are in the Lu-177 field, don't miss this information." The Lu-177 radiopharmaceuticals sector stands at a critical juncture, necessitating urgent collaboration. Our shared ...
mehrJohnson & Johnson Vision announces launch of ELITA™ Platform to Correct Myopia with New SILK Procedure at the European Society of Cataract and Refractive Surgeons Congress
London (ots/PRNewswire) - Next-generation laser vision correction provides next-day results and recovery1,2 - The next-generation ELITATM Femtosecond Laser to correct myopia with the new SILK procedure** - The latest innovation in extended depth of focus (EDOF) intraocular lenses (IOLs) will be shared with invited ...
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