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.
Johnson & Johnson subsidiary Janssen has launched a human clinical trial of its experimental Ebola vaccine in the UK, with much larger clinical trials expected to start this spring in the U.S. and Africa. Read More
Gilead Sciences has signed an exclusive deal with CVS Health Corp. to cover its hepatitis C drugs Sovaldi and Harvoni, a move that follows rival AbbVie’s exclusive deal late last month with pharmacy benefit giant Express Scripts to cover its combination therapy. Read More
Ranbaxy’s 180-day marketing exclusivity period for its version of Novartis’ blockbuster hypertension drug Diovan ended yesterday, prompting a flood of generic competition. Read More
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
Investigators conducting clinical trials in India could for the first time face up to five years in jail for trial violations if lawmakers approve a proposed bill, a possibility that could further hinder the country’s clinical trials industry, one expert says. Read More
In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
The FDA moved one step closer to clearing the first biosimilar in the U.S. after agency staff recommended approval of Sandoz’s chemotherapy side-effect drug Zarzio, a version of Amgen’s blockbuster Neupogen. Read More
Halozyme Therapeutics’ pegylated recombinant human hyaluronidase last month won orphan drug designation for pancreatic cancer from the European Medicines Agency, marking the therapy’s second orphan drug win in 2014. Read More