We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Medicines Agency is revising the way drugmakers conduct studies of drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The FDA is advising devicemakers that plan to support a premarket submission with data from clinical studies conducted outside the U.S. to meet with the agency before finalizing their trial designs. Read More
The FDA saw an 11 percent increase in inspections carried out as part of a sweeping program to improve inspectors’ understanding of clinical practices during fiscal year 2014. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More
A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More