Articles
Overcoming the challenges of clinical trial recruitment using big data technologies
The problem defined: Any prospective new drug must successfully pass a succession of three clinical trials phases, before it can apply for market approval.
These trials represent a significant investment for a pharma company and, as they are prone to delays...
Articles
Cell based therapy and FDA review: Partnering for success at your pre-IND meeting
Regenerative and cell-based therapies have only recently begun to deliver on the promise they have portended for years, creating opportunities to positively impact patient outcomes and professional success.
In the same way that these new and exciting biological approaches have...
Clinical Trials
Recipharm opens new GMP suite for clinical trial material
Recipharm, the contract development and manufacturing organisation (CDMO), has opened a newly built GMP suite for clinical trial material (CTM) manufacture at its facility in Research Triangle Park, North Carolina, USA. The suite, which represents a...
Clinical Trials
MGC Diagnostics Announces Clinical Study to Evaluate the Diagnostic Accuracy of FOT
MGC Diagnostics Corporation , a global medical technology company, today announced a new clinical study collaboration with Restech Srl to evaluate the diagnostic accuracy of the forced oscillation technique (“FOT”) to detect lung function abnormalities. Worldwide enrollment, expected to...
Clinical Trials
Inovio Ebola Vaccine Demonstrates Robust Immune Responses with Favorable Safety Profile in Expanded Clinical Trial
Inovio Pharmaceuticals, Inc. announced preliminary results from the expanded stage of its phase I study, EBOV-001. The expanded study examined different regimens of its Ebola DNA vaccine INO-4201 using intradermal (skin) administration. The results across both...
Clinical Trials
Cytori Receives FDA Approval for Burn Clinical Trial Related to BARDA Contract
Cytori Therapeutics, Inc. announced that the U.S. FDA has approved an IDE for a pilot clinical trial to evaluate Cytori Cell Therapy™ in patients with thermal burn injury. This trial, named the RELIEF trial, is a...
Clinical Trials
Kiadis Pharma receives regulatory approval for next trials for ATIR101 and ATIR201
Kiadis Pharma N.V. , a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders announces that it has obtained regulatory approval from the national authority in Belgium. The FAGG,...
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