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Central nervous system drugs that treat conditions such as Alzheimer’s and Parkinson’s disease lag behind other drugs in clinical development and approval times, a recent report finds. Read More
The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More
Pharma companies today spend on average $2.6 billion to get new products to market, a 145 percent increase in R&D costs compared with a decade ago, the Tufts Center for the Study of Drug Development reports. Read More
Drug and device manufacturers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More
The EU ombudsman is questioning the European Medicines Agency’s claim that it wasn’t violating any laws when it allowed AbbVie to redact information from clinical study reports. Read More
Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, now have a centralized place to bring their ideas for advice, thanks to a new streamlined system that replaces the old fragmented process. Read More
The FDA expects to release rules on international clinical trials by the end of next year, according to HHS’ 2015 agenda, which was unveiled Nov. 24. Read More
Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says. Read More
Reversing course, the UK’s healthcare cost agency now is recommending Janssen’s Stelara for psoriatic arthritis after the drugmaker agreed to provide the drug at a discount. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
A federal judge has paved the way for generic entry of Cubist’s antibiotic Cubicin by 2016 after striking down four out of five patents challenged by Hospira. Read More
A House bill would for the first time require drugmakers to create and disclose an expanded access policy in exchange for receiving breakthrough therapy designation, redeeming a priority review voucher or having the drug become a qualified infectious disease product. Read More