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Month: June 2020

UK’s MHRA renews EAMS Scientific Opinion for Santhera’s Idebenone in Duchenne Muscular Dystrophy

Pratteln, Switzerland, June 23, 2020 – Santhera Pharmaceuticals (SIX: SANN) announces that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinion for idebenone for patients with Duchenne muscular dystrophy (DMD) in respiratory function decline who are not taking glucocorticoids. With this renewal, the MHRA again confirmed its positive scientific opinion for idebenone under the EAMS while a corresponding European marketing authorization application (MAA) is currently under review.By renewing the EAMS1, the MHRA continues to enable access to idebenone for DMD patients with respiratory function decline, a leading cause of increased morbidity and early death for which no approved therapy exists. A conditional marketing authorization...

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Britische Arzneimittelbehörde MHRA erneuert EAMS Scientific Opinion für Santhera‘s Idebenon bei Duchenne-Muskeldystrophie

Pratteln, Schweiz, 23. Juni 2020 – Santhera Pharmaceuticals (SIX: SANN) gibt bekannt, dass die britische Arzneimittelbehörde MHRA (Medicines and Healthcare products Regulatory Agency) die Early Access to Medicines Scheme (EAMS) Scientific Opinion für Idebenon zur Behandlung von Patienten mit Duchenne-Muskeldystrophie (DMD) und abnehmender Atmungsfunktion, ohne Glukokortikoid-Begleitmedikation, für ein weiteres Jahr erneuert hat. Mit dieser EAMS-Verlängerung bestätigte die MHRA erneut ihre positive wissenschaftliche Beurteilung für Idebenon, für das derzeit ein entsprechender europäischer Zulassungsantrag (MAA) geprüft wird.Mit der Erneuerung des EAMS1 ermöglicht die MHRA weiterhin den Zugang zu Idebenon für DMD-Patienten mit abnehmender Atmungsfunktion, einer Hauptursache für erhöhte Morbidität und frühen Tod, für die es keine zugelassene...

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Sanofi’s virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients

Sanofi’s virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patientsR&D strategy driving pipeline momentum, productivity and innovationSignificant progress made since December 2019 on priority pipeline programs that have the potential to transform patient careFirst multiple sclerosis patient has been enrolled in the Phase 3 program for brain penetrant BTK inhibitor ‘168Positive THOR-707 “not-alpha” IL-2 first-in-human biomarker dataAccelerated development timeline for COVID-19 recombinant protein-based vaccine with potential approval in H1 2021Virtual R&D Day investor event today from 3:00-5:30 pm CET / 9:00-11:30 am ETPARIS – June 23, 2020 – Sanofi Chief Executive Officer Paul Hudson, Global Head of R&D John Reed, M.D.,...

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Journée virtuelle dédiée à la R&D de Sanofi : présentation des capacités et plateformes technologiques ainsi que l’expertise dans les voies de signalisation des maladies, pour le développement de médicaments ayant le potentiel de transforme

Journée virtuelle dédiée à la R&D de Sanofi : présentation des capacités et plateformes technologiques ainsi que l’expertise dans les voies de signalisation des maladies, pour le développement de médicaments ayant le potentiel de transformer la prise en charge des patientsUne stratégie de R&D au service du portefeuille de développement, de la productivité et de l’innovationProgrès significatifs opérés depuis décembre 2019 dans l’exécution des programmes prioritaires ayant le potentiel de transformer la prise en charge des patientsLe premier patient atteint de sclérose en plaques a été inclus dans le programme de phase III consacré à l’inhibiteur BTK ‘168 à pénétration cérébraleDonnées positives sur les biomarqueurs pour la première étude chez l’homme de l’IL-2 « non alpha » THOR-707Développement accéléré d’un vaccin à base de...

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Sanofi and Translate Bio Expand Collaboration to Develop mRNA Vaccines Across All Infectious Disease Areas

— The two companies will build upon their existing collaboration to pursue novel mRNA vaccines aimed at broadly addressing current and future infectious diseases —— Translate Bio to receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones/payments as well as tiered royalties on worldwide sales of developed vaccines —— Sanofi to receive exclusive worldwide rights to develop, manufacture and commercialize infectious disease vaccines using Translate Bio technology —— The expanded collaboration brings together Translate Bio’s leading mRNA technology and manufacturing with Sanofi’s world class vaccine development and distribution —PARIS and LEXINGTON, Mass., June 23, 2020 (GLOBE NEWSWIRE) — Sanofi...

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Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas

Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areasThe two companies will build upon their existing collaborationto pursue novel mRNA vaccines aimed at broadly addressingcurrent and future infectious diseasesTranslate Bio to receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones/payments as well as tiered royalties on worldwide sales of developed vaccinesSanofi to receive exclusive worldwide rights to develop, manufacture and commercialize infectious disease vaccines using Translate Bio technologyThe expanded collaboration brings together Translate Bio’s leading mRNA technology and manufacturing with Sanofi’s world class vaccine development and distributionPARIS and LEXINGTON, MASS. –...

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Sanofi et Translate Bio élargissent leur collaboration pour développer des vaccins à ARNm contre toutes les catégories de maladies infectieuses

Sanofi et Translate Bio élargissent leur collaboration pour développer des vaccins à ARNm contre toutes les catégories de maladies infectieusesLes deux entreprises vont renforcer leur collaboration actuelle en vue de développer de nouveaux vaccins à ARNm pour la prévention étendue des maladies infectieuses actuelles et futures.Translate Bio va recevoir un paiement initial de 425 millions de dollars, incluant une participation dans son capital sous la forme d’actions ordinaires, et pourra recevoir globalement jusqu’à 1,9 milliard de dollars de paiements d’étape potentiels, ainsi que des redevances progressives sur les ventes mondiales des vaccins développés ; Sanofi obtient des droits exclusifs mondiaux.Sanofi recevra les droits mondiaux exclusifs pour développer, fabriquer et commercialiser des vaccins contre les maladies infectieuses...

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African Gold Group Achieves Major Environmental Sustainability Milestone in Spite of COVID-19 Crisis

TORONTO, June 23, 2020 (GLOBE NEWSWIRE) — African Gold Group, Inc. (TSX-V: AGG) (“AGG” or the “Company”) is pleased to announce a partnership with DRA Nexus, a diversified global engineering, project delivery and operations management group to build and install a hybrid power solution on its fully permitted Kobada Gold Project in Southern Mali.This landmark installation will enable AGG to increase the environmental sustainability of the Kobada Gold Project, in turn differentiating AGG from its peers and potentially attracting partnership opportunities from green energy funds, socially responsible investment managers, family offices and endowment funds.Highlights of the power system include:Significant annual power savings over a conventional thermal power system of more than 22% or $5 million on cost of powerEnvironmental sustainability...

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Transcontinental Advanced Coatings announces the launch of reflex™ CE Gloss, clear gloss hardcoated polyester film

MONTRÉAL, June 23, 2020 (GLOBE NEWSWIRE) — Transcontinental Advanced Coatings announces that it has added reflex™ CE Gloss high-performance films to its reflex™ line of hardcoated films. The new reflex™ CE Gloss is a clear gloss, hardcoated film formulated on optical grade, highly stabilized polyester. It is coated in a certified ISO Class 7 (Class 10,000) cleanroom. The product boasts a scratch-resistant, proprietary hardcoat formulation on one side of the film and a print receptive coating on the other, enabling printing with both solvent and UV screen print inks.The performance characteristics of reflex™ CE Gloss include excellent optical clarity and haptic functionality, exceptional hardness, chemical resistance, and flexibility that enables embossing. The price-performance point of reflex™ CE Gloss makes it the ideal product...

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