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The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More
The FDA is asking Acura Pharmaceuticals to conduct an additional study to prove its abuse-deterrent painkiller can actually deter abuse, throwing a wrench into the small drugmaker’s plans for approval. Read More
Rigel Pharmaceuticals said Wednesday it will not initiate any new studies of R348 for the treatment of dry eye disease, after the compound failed to meet its primary and secondary endpoints in a recently completed Phase II trial. Read More
The EU-based Innovative Medicines Initiative is launching a $4.5 billion decade-long effort to improve the success rate of clinical trials for certain drugs by 30 percent and boost exclusivity to entice sponsors to develop the drugs. Read More
The goal of recruiting sufficient numbers of minority patients at U.S. clinical trial sites is hardly ever reached, rather than hard to reach, a trials expert says. Read More
Patient recruitment remains one of the biggest roadblocks to speedy clinical trials, but the problem could be eased with greater use of electronic health records, a panel of experts told lawmakers July 10. Read More
Manufacturers of botulinum toxin intended to erase facial wrinkles should develop safeguards that reduce the risk of inadvertent injection and other safety issues with the product, according to the FDA. Read More
Drugmakers want the FDA to harmonize new draft guidance on conducting clinical trials for resistant pneumonia treatments with EU regulations to ease development burdens. Read More
Difficulties finding the right patients for clinical trials and high active pharmaceutical ingredient costs are among the most pressing challenges in bringing new antibiotics for resistant infections to market. Read More
The FDA hopes to spur development of pediatric rare disease treatments through a series of forthcoming guidances that will address issues such as how to conduct clinical trials for pediatric oncology products and common challenges in developing rare disease treatments. Read More
A European public-private partnership is launching a new $4.5 billion decade-long effort to improve the success rate of clinical trials on certain drugs by 30 percent and boost exclusivity to make manufacturing treatments more enticing. Read More
The Duchenne muscular dystrophy community wants the FDA to consider patients’ and caregivers’ views when conducting risk-benefit analyses in clinical trials of new treatments for the disease. Read More