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.
To shed light on the regulatory requirements for the development of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More
Industry is praising the FDA for tackling both hiring and retention in its proposed goals for the next PDUFA, touting the proposals as necessary to support the agency’s initiatives. Read More
Gilead Sciences and Emory University have filed two lawsuits in U.S. District Court for the District of New Jersey against an India-based company over the patent rights to the HIV drug Truvada. One of the suits is related to two of the patents; another is related to all four patents. Read More
In yet another move toward precision medicine this week, the FDA is mapping out co-development pathways for companion diagnostic devices to accompany targeted therapies. Read More
The UK’s drug pricing watchdog is recommending reimbursement of AstraZeneca’s drug Brilique for patients with a previous history of heart attacks. Read More
In a move that may hinder companies looking to develop generic Tyvaso, the combination product’s developer is asking the FDA to impose stringent approval requirements on generic competitors. Read More
A federal judge has ordered AbbVie to release documents to the Federal Trade Commission related to its marketing of its testosterone treatment AndroGel. Read More