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 ...
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 ...
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 ...
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 ...
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 ...
LTS Lohmann Therapie-Systeme AG
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 ...
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 ...
STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara - Marketing authorization issued in European Economic Area for Uzpruvo®, the first biosimilar to Stelara®, a biologic therapy within ...
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 ...
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 ...
Vancouver, Bc (ots/PRNewswire) - BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") announced today that it has executed a non-binding Letter of Intent ("LOI") to acquire the core platform technology and entire immunotherapeutics intellectual property portfolio of discovery, preclinical development, and Phase II clinical study ...
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 ...
LTS Lohmann Therapie-Systeme AG
LTS Lohmann Therapie-Systeme AG
Fraunhofer-Institut für Produktionstechnologie IPT
Takeda Pharma Vertrieb GmbH & Co. KG
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 ...
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 ...
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 ...
Duesseldorf (ots) - - Gerresheimer among the top 5% of assessed businesses - Total score increases to 72/100 points - Status demonstrates consistent implementation of CSR strategy Gerresheimer, an innovative provider of systems and solutions and a global partner for the pharma, biotech, and cosmetic industries, has once again been awarded Gold status by the ratings agency EcoVadis. EcoVadis assesses the performance of ...
