On December 18, 2015, the U. S. Food and Drug Administration (FDA) expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or metastatic melanoma with pembrolizumab. read more
Ionis Pharmaceuticals Earns $5 Million Milestone Payment from Biogen for Advancing a New Program Under Its Broad Neurology Strategic Collaboration
CARLSBAD, Calif., Dec. 22, 2015 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today it has earned a $5 million milestone payment from Biogen associated with the validation of an undisclosed target to treat patients with an undisclosed neurological disorder. Ionis and Biogen have a broad strategic collaboration to develop drugs to treat patients with neurological disorders. For this newest target, Ionis will continue to evaluate the target with the goal of advancing this program into development. read more
Alexza Pharmaceuticals Announces Interim Results from its Phase 2a Study of AZ-002 (Staccato® alprazolam) in Epilepsy Patients
/PRNewswire/ — Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced interim results of its Phase 2a study of AZ-002 (Staccato® alprazolam) in epilepsy patients. AZ-002 produced a dose-related decrease in mean Standardized Photosensivity Range (SPR), the primary endpoint in the study. AZ-002 is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS). ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs. read more
Duke University Delegation Visits NCKU to Foster Partnership for Ventricular Assist Device
TAINAN, Taiwan–(BUSINESS WIRE)–Dr. Carmelo Alessio Milano, the Surgical Director for Heart Transplant and LAVD Program, from Duke University School of Medicine, United States, led a delegation to visit National Cheng Kung University (NCKU), Tainan, Taiwan, on December 21 for further collaboration on advancing a new cardiac assist device. for more information contact firstname.lastname@example.org
TSO3 Completes Additional Studies, Files Extended U.S. Claims for Breakthrough Medical Device Sterilizer
Company Submits Required Documentation Seeking Clearance to Extend Sterilization Claims to Include up to Eight Channels in a Single Device for its STERIZONE® VP4 Sterilizer – an Industry First
QUÉBEC CITY, Dec. 22, 2015 /CNW Telbec/ – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, has filed with the U.S. Food and Drug Administration recently completed studies that support an expanded indication for use of its STERIZONE® VP4 Sterilizer.
Regulatory clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for flexible endoscopes. read more
Baxalta’s ADYNOVATE Meets Endpoints in Phase 3 Study of Hemophilia A Patients Under 12 Years of Age
BANNOCKBURN, Ill., Dec. 21, 2015 /PRNewswire/ — Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)]. ADYNOVATE was approved by the U.S. Food and Drug Administration (FDA) in November 2015 for use in adolescent and adult hemophilia patients (12 years and older) for on-demand treatment and control of bleeding, and prophylaxis to reduce the frequency of bleeding episodes. read more
Sectra and Major Private Care Provider Extend Cooperation with a New Contract for Two Countries
LINKÖPING, Sweden–(BUSINESS WIRE)–Sectra (STO: SECTB) has signed a new six-year contract with Unilabs, a leading care provider for radiology and laboratory medicine in the Nordic region. The contract comprises Sectra’s IT-solution for the handling and storage of radiology images and patient information (PACS and RIS) for Unilabs’ Swedish and Norwegian businesses. Sectra’s IT solution enhances accessability and simplifies communication of medical images in and between hospitals, thus facilitating radiologists’ everyday work and contributing to better and more efficient care. The order value amounts to approximately EUR 6.5 million. read more
Moberg Pharma expects to announce phase II data for BUPI in January
Moberg Pharma AB (OMX: MOB) today announced that topline data from the clinical phase II-study for BUPI is expected to be announced in January
The BUPI lozenge is investigated in a clinical phase II study with the aim of demonstrating an added benefit to standard pain treatment. Earlier this year, the inclusion period was extended after an amendment of the inclusion criteria which introduced a threshold pain level for patients to be included in the study.
Haselmeier Self-Injection Devices go Connected
Haselmeier has added connectivity to its devices portfolio with the announcement of its new Axis-D-Connect Disposable Pen Injector. Haselmeier has partnered with the Austrian Institute of Technology GmbH (AIT) to equip its Axis-D platform pen with AIT`s cartridge fill-level measurement system. The innovative and patented technology provides a simple and intuitive solution for patients while creating an integrated device solution with a range of features that include: device ID and authentication, electronic health record (HER) integration and remote physician monitoring and interaction. All features which are designed to support better therapy adherence and improved patient outcomes.