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Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More
HHS on Sept. 2 proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
A decline in spending on clinical research following implementation of the Physician Payment Sunshine Act could change the clinical trial landscape if it becomes an ongoing trend, an expert warns. Read More
Concordia Healthcare is acquiring UK-based Amdipharm Mercury for $3.5 billion, in a deal that greatly expands the Canadian drugmaker’s generic portfolio and global reach. Read More
GlaxoSmithKline’s Breo Ellipta failed to meet its primary goal in a pivotal clinical trial of curbing death risk in patients suffering from chronic pulmonary obstructive disease. Read More
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More