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The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
Wilex’s Germany-based subsidiary Heidelberg Pharma and Roche have extended an existing 2013 license agreement to apply the antibody drug conjugate (ADC) technology for the further development of Roche antibodies. The aim is to identify and develop novel Antibody Targeted Amanitin Conjugates (ATACs) based on Heidelberg Pharma's patented technology to couple α-Amanitin to antibodies.
CytRx, a Los Angeles-Calif.-based biopharmaceutical R&D company specializing in oncology, has commenced operations at its new discovery laboratory in Freiburg, Germany. The new laboratory will conduct discovery and translational research to create drug candidates that utilize novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors.
The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovation Office has set up a portal for all regulatory queries concerning regenerative medicines, the Regenerative Medicines Regulatory Advice Service. A “one-stop shop” service, it will provide a single point of access from the four regulators in the field: the Human Tissue Authority (HTA), the Human Fertilization and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), which will provide a coordinated single response service for free regulatory advice.
Astellas Pharma, based in Tokyo, Japan, has formed a research collaboration with an investigator at Harvard Medical School in Boston, Mass., focused on discovering the pathologic mechanism for retinitis pigmentosa and identification of new therapeutic targets. Astellas and Harvard aim to provide a new treatment option, possibly gene therapy, to retinitis pigmentosa patients who have difficulty maintaining good vision.
Exostar, a Herndon, Va.-based provider of secure, cloud-based solutions that improve collaboration, information sharing and supply chain management for communities of partners, has become a specialist member of the BT for Life Sciences partner ecosystem. Exostar’s secure identity and access management (IAM) and enterprise federation solutions now can be paired with BT’s Workbench Informatics solution for scientists.
Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.
RepliCel Life Sciences, a Vancouver-based clinical stage regenerative medicine company focused on the development of autologous cell therapies, is the newest member of the Center for Commercialization of Regenerative Medicine’s (CCRM) industry consortium, a Canadian not-for-profit organization.
KCR, a European CRO, has launched KCR Date Forecaster, a mobile application providing patients with smart scheduling and automatic reminders for doctor appointments and medical examinations.
Bristol-Myers Squibb, Pharmacyclics and Janssen R&D have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of BMS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.
Alexion Pharmaceuticals, a Cambridge, Mass.-based developer of breakthrough therapies for patients with severe and life-threatening rare diseases, and Cincinnati Children’s Hospital Medical Center have established the Alexion Rare Disease Innovation Fund for the advancement of research in rare disease.
Hayward, Calif.-based Impax Laboratories will acquire Tower Holdings, including operating subsidiaries CorePharma, based in Middlesex, N.J., Amedra Pharmaceuticals, based in Horsham, Penn., and Lineage Therapeutics, also based in Horsham, for $700 million in cash, subject to certain customary purchase price adjustments.
Aastrom Biosciences, a developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, plans to change its corporate name to Vericel and move its corporate headquarters from Ann Arbor, Mich., to Cambridge, Mass. The corporate name change is subject to the approval of Aastrom's shareholders. Aastrom will continue to maintain manufacturing facilities in Cambridge and Ann Arbor.
Clinical Conductor, created by Rochester, N.Y.-based Bio-Optronics, a provider of software and services to healthcare and life sciences organizations, has launched new enhancements to the Clinical Conductor CTMS. This oncology-focused release is the first of several and adds advanced features and functionalities designed to optimize the management and execution of oncology studies at organizations of all sizes and makeups.
Medidata, a New York-based global provider of cloud-based solutions for clinical research, has announced the latest release of the Medidata Clinical Cloud and the immediate availability of new capabilities and enhancements that broaden the company’s platform of advanced technologies and data analytics. The new features are designed to optimize clinical trial processes and enhance sponsor-site relationships.
NICE is developing two new guidelines to help tackle the growing threat of antibiotic resistance. The first is on safe and effective antimicrobial stewardship in relation to the use of antimicrobials in health and social care, and the second is a public health guideline that will focus on changing people’s knowledge, attitudes and behaviors in relation to the use of antimicrobials.
The NIH has invested to develop new strategies to analyze and leverage increasingly complex biomedical data sets, often referred to as Big Data. These NIH multi-institute awards constitute an initial investment of nearly $32 million by NIH’s Big Data to Knowledge (BD2K) initiative, which is projected to have a total investment of nearly $656 million through 2020, pending available funds.
Covance has entered an in-kind collaboration with Novartis Institutes for Biomedical Research (NIBR) to accelerate the development of a state-of-the-art clinical data warehouse designed to support data integration and meta-analysis for preclinical and clinical research.
Accenture, an Ireland-based global management consulting, technology services and outsourcing company, has launched Accenture Life Sciences Cloud for R&D, which speeds clinical development, helps improve patient outcomes and creates greater R&D efficiency through a new single analytics platform that brings together multiple internal and external data sources across clinical, safety, regulatory and operational functions.
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies