Industry News

FDA approves Ofev to treat idiopathic pulmonary fibrosis

Centerwatch - Thu, 2014-10-16 07:49
The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
Categories: Industry News

WILEX subsidiary Heidelberg Pharma, Roche extend collaboration

Centerwatch - Thu, 2014-10-16 05:00
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.
Categories: Industry News

CytRx launches discovery laboratory to develop anti-cancer drug platform

Centerwatch - Thu, 2014-10-16 04:31
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.
Categories: Industry News

MHRA sets up ‘one-stop shop’ for advice on regenerative medicine

Centerwatch - Thu, 2014-10-16 04:00
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.
Categories: Industry News

Astellas, Harvard Medical School investigator collaborate

Centerwatch - Thu, 2014-10-16 03:30
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.  
Categories: Industry News

Exostar, BT partner

Centerwatch - Thu, 2014-10-16 03:00
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.
Categories: Industry News

Celerion joins Cardiac Safety Research Consortium

Centerwatch - Thu, 2014-10-16 03:00
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.
Categories: Industry News

CCRM, RepliCel to partner on development of cell therapies for tendon repair

Centerwatch - Thu, 2014-10-16 02:30
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.
Categories: Industry News

KCR launches KCR Date Forecaster app for medical appointment scheduling

Centerwatch - Wed, 2014-10-15 17:00
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. 
Categories: Industry News

Bristol-Myers Squibb, Pharmacyclics and Janssen collaborate

Centerwatch - Wed, 2014-10-15 16:00
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.
Categories: Industry News

Alexion, Cincinnati Children’s launch rare disease innovation fund

Centerwatch - Wed, 2014-10-15 14:30
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.
Categories: Industry News

Impax to acquire Tower Holdings and Lineage Therapeutics

Centerwatch - Wed, 2014-10-15 14:00
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.
Categories: Industry News

Aastrom Biosciences to change name to Vericel, move headquarters to Massachusetts

Centerwatch - Wed, 2014-10-15 13:30
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.
Categories: Industry News

Clinical Conductor CTMS launches oncology updates

Centerwatch - Wed, 2014-10-15 09:45
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.
Categories: Industry News

Medidata updates Medidata Clinical Cloud

Centerwatch - Wed, 2014-10-15 09:40
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.
Categories: Industry News

NICE develops new guidelines for antibiotic resistance

Centerwatch - Wed, 2014-10-15 09:39
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.
Categories: Industry News

NIH invests $32 million to increase utility of biomedical research data

Centerwatch - Wed, 2014-10-15 09:22
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.
Categories: Industry News

Covance, Novartis collaborate to develop a clinical data warehouse

Centerwatch - Wed, 2014-10-15 09:21
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.
Categories: Industry News

Accenture launches Cloud for R&D, forms Cloud Coalition

Centerwatch - Wed, 2014-10-15 09:19
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.
Categories: Industry News

Written Requests Issued

FDA News - Wed, 2014-10-15 08:38
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies
Categories: Industry News
Syndicate content