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Astellas and Pfizer Announce Amendment to Clinical Research Protocol for Phase 3 PROSPER Trial of enzalutamide

Astellas Pharma Inc and Pfizer Inc announced the amendment of the protocol for the registrational PROSPER trial, a multi-national, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of XTANDI in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC)....

HedgePath Pharma Announces granting of Type-C meeting request by FDA and provides positive clinical trial update

HedgePath Pharmaceuticals, Inc , a clinical stage biopharmaceutical company that discovers,ย develops and plans to commercialize innovative therapeutics for patients with cancer. Announced theย grant of a Type-C Guidance Meeting Request by the U.S. FDA concerning further guidance...

KUKA Medical Robotics at the CMEF in Shanghai:ย robots assist surgeons dur-ing operations

KUKA is showcasing the possibilities of using sensitive robots to support doc-tors at the flagship show for the medical technology sector, China International Medical Equipment Fair (CMEF) in Shanghai from 15 to 18 May 2017 ย ...

AstraZeneca Imfinzi significantly reduces the risk of disease in the Phase III PACIFIC trial for lung cancer

AstraZeneca and MedImmune, its global biologics research and development arm announced positive results for the Phase III PACIFIC trial, a randomised. Double-blinded, placebo-controlled multi-centre trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable...

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. Theseย trials represent a significant investment for a pharma company and, as they are prone to delays...

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...

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...

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