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Novartis publishes CTL019 data for acute lymphoblastic leukemia

Thursday, October 16, 2014 11:55 AM

Novartis and the University of Pennsylvania's Perelman School of Medicine have announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor (CAR) therapy CTL019.

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

Thursday, October 16, 2014 11:49 AM

The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

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WILEX subsidiary Heidelberg Pharma, Roche extend collaboration

Thursday, October 16, 2014 09:00 AM

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.

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CytRx launches discovery laboratory to develop anti-cancer drug platform

Thursday, October 16, 2014 08:31 AM

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.

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

Thursday, October 16, 2014 08:00 AM

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.

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Astellas, Harvard Medical School investigator collaborate

Thursday, October 16, 2014 07:30 AM

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.  

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Exostar, BT partner

Thursday, October 16, 2014 07:00 AM

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.

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Celerion joins Cardiac Safety Research Consortium

Thursday, October 16, 2014 07:00 AM

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.

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

Thursday, October 16, 2014 06:30 AM

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.

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KCR launches KCR Date Forecaster app for medical appointment scheduling

Wednesday, October 15, 2014 09:00 PM

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. 

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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Standout sponsors reveal how they shorten regulatory, clinical cycle times

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