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A potential cure for amyotrophic lateral sclerosis (ALS) remained elusive this week as two pharma companies shuttered trials that just barely missed the efficacy mark. Read More
The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and sometimes decades — to evaluate, adopt and fully implement new technologies and methods. Read More
Over the past week, the FDA issued a notice of Abbott’s withdrawal of Cylert NDA, draft guidance on generally accepted scientific knowledge and final guidance on covariates in randomized clinical trials. Read More
The FDA issued four guidance documents on Thursday covering a variety of topics, including efficacy endpoints for antidiabetic drugs, adjusting for covariates in randomized clinical trials, electronic submission of study data and tissue containment systems used during power morcellation procedures.Read More
This month, our review of recent clinical trial results features a drug for anemia due to chronic kidney disease that saw success after an FDA complete response letter, positive results for an ovarian cancer treatment and a hemophilia therapy as well as a lymphoma drug trial derailed by a serious adverse reaction.Read More
A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Read More
India-based drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) has drawn two FDA warning letters in recent weeks over untested glycerin in gastrointestinal products for children, among other serious current good manufacturing practice (cGMP) violations. Read More
The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance. Read More
The International Council on Harmonisation (ICH) has released a draft guideline on good clinical practice (GCP), designed to facilitate acceptance of clinical trial data by ICH member countries and regions. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA’s sterilization pilot. Read More