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Surrogate Endpoints: Benefits, Issues And The Future

On a mild day in April 2016, a Marriott Hotel conference room in Hyattsville, Md., was the scene of one of the most politically charged panel meetings the US Food and Drug Administration held in years. A throng of parents and young boys in wheelchairs hoped to convince a committee to endorse the use of a controversial drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease.

Clinical Trials Research and Development Strategies Outlook 2019

Pharma Told To Get It Right First Time On Clinical Trial Data

Drug companies are complying with their obligation to submit clinical trial results to the US-based database, but major errors in their submissions prevent the results from being uploaded in a timely manner.

Clinical Trials Outlook 2019 Market Intelligence

Ovarian Cancer Pipeline Review: Sponsors Plan Frontline Punch, Smart Combinations

Combination studies of drugs for ovarian cancer have heavy focus on PARP, PD-1/L1 and VEGF mechanisms.

Commercial ImmunoOncology Cancer

INFOGRAPHIC: Winners In 2019 Launches

Highlighting key late-stage drugs that could reach their first markets during 2019, including first-in-class products, medicines likely to become standards of care, and products introduced for major new indications.

Policy & Regulation Approvals Research & Development