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At least 75 percent of clinical trials are extended by six weeks or more because of failure to enroll enough patients, a new study finds, but help may be on the way in the form of “big data.” Read More
Chelsea Therapeutics’ second encounter with an FDA advisory panel over its blood pressure drug Northera has garnered an even stronger positive nod than a 2012 vote that resulted in a surprise complete response letter. Read More
Japanese authorities Friday launched an investigation into claims that falsified clinical trial data was used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More
Over the next five years, the FDA plans to release a host of guidances to implement the standardization of electronic drug applications and other regulatory submissions. Read More
PhRMA is resisting the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
The European Medicines Agency has postponed indefinitely a controversial transparency initiative that would make publicly available detailed information from clinical study reports contained in new drug applications. Read More
Discussions with Alimera ahead of a January advisory committee meeting led the FDA to conclude that the company’s diabetic macular edema drug would be approvable with labeling changes and additional safety data — foregoing the need for the meeting and additional clinical trials. Read More
Manufacturers of antibacterial soaps and body washes may be mandated by the FDA to submit clinical outcome study data on the safety and efficacy of their products, bringing them in line with the agency’s regulation of other over-the-counter medications. Read More
While MiMedx disagrees with the FDA’s reasoning for requiring BLAs — and, hence, clinical trials — for its regenerative, human cellular and tissue-based products (HCT/Ps), the company says it will oblige the agency to set precedence for future products developed by competitors. Read More
The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead.Read More
Drugmakers could be required to submit less data for antibiotics and antifungals that affect limited patient populations if a new House bill aimed at building on the success of the Generating Antibiotics Now Act is passed into law. Read More