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 Medicines Company’s Kengreal may be on the road to approval, with FDA reviewers backing its use as a post-angioplasty anticlotting agent one year after the agency rejected the drug for this and another indication. Read More
Japan’s drug authority will grant conditional approval to human embryonic and somatic stem cell therapies based on limited clinical data, under a new approval pathway meant to speed patient access to innovative products. Read More
Canadian biotech company Tekmira will restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, following the FDA’s downgrading of a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
The FDA and Health Canada will meet May 15 in White Oak, Md., to discuss a wide range of international pharma guidelines — the first joint meeting since the agencies formed a Joint Regulatory Cooperation Council in 2011. Read More
Pharma companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of drug’s approval or rejection, according to April 1 guidance that sets specific timelines for every step of the dispute resolution process. Read More
Drugmakers are being asked to partner with the U.S. National Institutes of Health, academics and biotechnology companies to develop new antibiotics, under a White House plan announced March 27. Read More
A German government agency says the EU’s plan for implementing a clinical trials database lets drugmakers withhold too much information — including study protocols, methods and trial results — under the exemption for commercial confidentiality. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More