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Isotopia 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 ...
moreNorgine 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 ...
moreFennec 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 ...
morePress release: STADA continues with double-digit sales and profit growth in 2023
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FDX Fluid Dynamix and Fraunhofer IPK to Collaborate with Lonza on Novel Nanoparticle Formulation Technology Platform FDmiX
more Epitomee® 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 ...
moreResearch Success in Rare Disease / RHEACELL receives positive signal for accelerated stem cell development program in rare ‚Butterfly Disease‘
moreLTS Lohmann Therapie-Systeme AG
First product based on LTS’ Sorrel(TM) wearable drug delivery platform launched in the US
moreHearing 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 ...
moreBiomay Announces its Successful Support of Approval of First CRISPR/Cas9-based Therapy
moreSHL Medical partners with SteriPack Group to set up final assembly service
moreEpitomee® 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 ...
moreSHL Medical further strengthens vertical capabilities with the acquisition of US manufacturer Superior Tooling Inc.
morePress release: STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara
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 ...
One documentmorePress release: Zuellig Pharma becomes STADA Philippines’ exclusive distribution partner
One documentmoreAcousia 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 ...
moreMedison 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 ...
moreBioVaxys Executes Letter of Intent for Major Immunotherapeutics Technology Acquisition
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 ...
morePRODUCTLIFE 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 ...
moreLTS Lohmann Therapie-Systeme AG
LTS receives $4.3 Million grant for the development of contraceptive Microneedle Array Patches
moreLTS Lohmann Therapie-Systeme AG
LTS receives grant of $1.2 Million to support the development of thermostable mRNA formulations for Microneedle Array Patches
moreFraunhofer-Institut für Produktionstechnologie IPT
Pooling expertise: Fraunhofer IPT and Harro Höfliger cooperate in the manufacturing of ATMP production systems
moreTakeda 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 ...
moreBehaVR 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 ...
moreBehaVR 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 ...
moreSHL Medical achieves EcoVadis® Silver Medal and sets ambitious science-based climate targets
moreBiomay Announces Expansion of GMP-Facilities to Offer mRNA Manufacturing and Aseptic Filling Services
moreIpsen 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, ...
moreGerresheimer awarded EcoVadis Gold status again
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 ...
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