Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B. The submission was based on a Phase II/III ...
US-based Medtronic has announced that its Micra transcatheter pacing system (TPS) has been implanted in the first patient in Austria as part of the company’s multi-center global clinical trial. The single-arm, pivotal clinical trial ...
Foundation Medicine, a molecular information company, has announced the launch of its second clinical product, FoundationOne Heme, a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma), as well as many ...
Sanofi has released results of a 24-week Phase IIIb clinical trial showing that Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered to patients either before breakfast or the ...
Tags: Diabetes Drug, Medicine
Bolton Medical, a medical device manufacturer, has initiated its Phase II US clinical trial to study the safety and effectiveness of the Treovance abdominal stent-graft with Navitel delivery system. The first two cases were performed on ...
InnaVirVax, a biopharmaceutical company, has commenced a Phase II clinical trial evaluating the therapeutic properties of the VAC-3S vaccine when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection. The ...
Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia facilitated subcutaneous infusion to treat adult patients with ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to Conatus Pharmaceuticals' drug candidate emricasan for the treatment of liver transplant patients with reestablished fibrosis to delay the progression to ...
Echo Therapeutics, a medical device company, has reported positive results from its clinical trial of the Symphony CGM wireless continuous glucose monitoring system in surgical patients in hospital critical care units. Echo Therapeutics ...
Navidea Biopharmaceuticals will collaborate with the University of Alabama at Birmingham (UAB) on a clinical study that will assess the safety and activity of a radiolabeled, humanized monoclonal antibody from its RIGS (radio-immuno-guided ...
VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already ...
DBV Technologies, creator of Viaskin, has entered into a collaboration agreement with BioNet-Asia and the University of Geneva (UNIGE) to work on a whooping cough (pertussis) booster vaccine. The clinical proof of concept product ...
Tags: DBV Technologies, Booster Vaccine
Let's say a large medical device company has developed a new computer heart simulator that the FDA thinks is acceptable for running tests--or a new clinical trial design in a cutting-edge field. In the past, a small, early-stage company ...
Tags: Big Medtechs, public-private Medical Device Innovation Consortium, FDA
Biotronik, a manufacturer of cardiovascular medical devices, has obtained the US Food and Drug Administration (FDA) approval for Phase B of the company’s ongoing ProMRI clinical trial. Biotronik has recently completed Phase A of the ...
Tags: Promri Clinical Trial, Biotronik
US-based Boston Scientific has obtained CE Mark approval for its Vercise deep brain stimulation (DBS) system for the treatment of intractable primary and secondary dystonia. Dystonia is a neurological movement disorder characterized by ...
Tags: Dystonia Treatment, DBS System