US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus ...
Boehringer Ingelheim has obtained marketing approval for Striverdi Respimat (olodaterol), a long-lasting bronchodilator indicated for chronic obstructive pulmonary disease (COPD), in the UK, Denmark and Iceland. This approval is based ...
The Intellectual Property & Science business of Thomson Reuters has announced the addition of clinical trials intelligence to the Thomson Reuters Cortellis suite, a comprehensive information solution for drug discovery and development. ...
Foundation Medicine, molecular information company, has announced that results from a 24-month, multi-institution collaboration demonstrating the analytic validation of its cancer genomic profiling assay, FoundationOne, were published in ...
Tags: Foundation Medicine
Israel-based Cardiosonic announced it is currently enrolling patients in the TIVUS II clinical trial, designed to assess the safety, efficacy and performance of its TIVUS system using a next generation multidirectional catheter. TIVUS ...
Tags: Cardiosonic, Clinical Trial
Cystic Fibrosis Foundation Therapeutics (CFFT), an affiliate of the CF Foundation, has provided $1.7m research award to US-based Savara Pharmaceuticals for advancing the development of AeroVanc (vancomycin hydrochloride inhalation powder). ...
PLC Systems, a medical device company, has obtained an approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to initiate a single-arm clinical trial in Japan using its RenalGuard therapy. This approval is based on MHLW's ...
Tags: PLC Systems, Renalguard Therapy
Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
US-based Pulsar Vascular has obtained CE Mark approval for its PulseRider device, designed to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy. With this CE Mark approval, the company now has full ...
Tags: Pulsar Vascular, CE Mark Approval
Biotronik, a manufacturer of cardio and endovascular medical devices, has announced that its DREAMS scaffold (DRug Eluting Absorbable Metal Scaffold) has been successfully implanted in the first coronary artery disease patient in Germany as ...
Tags: Biotronik, medical devices
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
The European Medicines Agency has launched a new version of the European clinical trials database, EudraCT V9. This new version marks the initial step of a process through which summary clinical trial results will be made publicly ...
Israeli pharmaceutical company Protalix BioTherapeutics has announced initial positive results from its Phase I clinical trial of oral glucocerebrosidase (GCD), or oral GCD (PRX-112), in patients with Gaucher disease. In the trial, oral ...
US-based drug delivery contract development and manufacturing organization (CDMO) Particle Sciences has completed manufacturing of vaginal rings with new architecture, essentially a powdered filled tube intended for HIV prevention. The ...
Tags: HIV Prevention, Particle Sciences
St. Jude Medical, a global medical device company, has completed the acquisition of Nanostim, a developer of miniaturized, leadless pacemakers. St. Jude Medical and Nanostim have entered into a series of agreements in May 2011, pursuant ...
Tags: St.Jude Medical, medical device