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FDA approves Roche’s Hemlibra for haemophilia A without factor VIII inhibitors

Roche announced that the US FDA has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors. ...

United Becomes First US Carrier to Approve CSafe RAP Temperature-Controlled Container

United Cargo announced it will enhance its TempControl service and expand the options it offers shippers of pharmaceuticals and other life science products by approving the new CSafe RAP active container. The CSafe RAP utilizes innovative...

Aptar Pharma QuickStart, an injectable device development kit, to launch at CPhI Worldwide

Aptar Pharma, a leading provider of innovative drug delivery systems, in combination with Schott Glass and EMA Pharmaceuticals, has announced that it will launch Aptar Pharma QuickStart™ for injectable drug development at CPhI Worldwide 2018, in Madrid, Spain, October...

Apceth to Manufacture First Potential One-Time Gene Therapy for Transfusion-Dependent Βeta-Thalassemia

apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, congratulates its partner bluebird bio on the acceptance and validation of its market authorization application by the European Medicines Agency (EMA). ...

MetP® Pharma Introduces Nascum®-Plus Against the Onset of Air Pollution-induced Inflammation

MetP® Pharma, focusing on the nasal delivery of drugs to the systemic circulation and especially to the brain, presents its Nascum®-Plus nasal gel. After application, a very thin, imperceptible protective layer forms on the nasal mucosa....

Orchard Therapeutics Receives EMA PRIME Designation for OTL-300, an Investigational Lentiviral Gene Therapy for the Treatment of Transfusion-Dependent Beta-Thalassemia

Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, announced that the EMA has granted Priority Medicines (PRIME) designation to OTL-300, an investigational autologous ex vivo lentiviral...

Piramal Pharma Solutions launches of Xcelerate Integrated Solutions

Piramal Pharma Solutions (PPS), a global leader in Contract Development and Manufacturing Solutions, announced the launch of its Xcelerate Integrated Solutions™ platform to address a rapidly growing market need. This platform will serve the increasing demand...

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